Thursday, 24 July 2014

India Faces Higher QC Costs As Shasun Shows Value Of Compliance

Increased recognition of FDA scrutiny and the cost of quality failures have led to drug manufacturers in India to double spending on compliance over the past 5 years, according to credit rating agency CRISIL. And investors in India are increasingly aware of the value of such investments, Shasun Pharma seeing shares jump 16% this week after they got through an FDA inspection with only one Form 483.



Shasun has fared better than some of its neighbors in regulatory inspections; with the withdrawal of 2,900 bottles ulcer drug ranitidine stomach is manufactured by Glenmark Pharmaceuticals is a recognized problem. The company still has been caught in the furor over quality control in India, however. In 2012, some people misinterpret a warning black for one of the products customers Shasun as a warning letter to the manufacturer box, resulting in the CEO having to clarify the situation in a television interview.

This week Shasun experienced investors across twitchiness about FDA warnings when the result of a survey sent its shares down 16%. FDA inspectors visited the plant in Tamil Nadu Shasun last month, pointing out what the company calls "483s minor", but generally considered that the installation complies with GMP. Mexican authorities also inspected the plant and concluded the plant was in full compliance. With everyone alert for the next crisis-like Ranbaxy, the result was seen as positive by Shasun remarkable. Claris Lifesciences also gained 7% after the FDA approved its API plant.

The fate of Ranbaxy and other drugmakers in India has put the focus on quality control and led to greater investment by manufacturers. In a report on the trend, CRISIL concluded training expenditure, compliance departments and preventive structured governance can reduce the likelihood of falling out of favor with the FDA. And the size of the U.S. market makes such investments worthwhile, with sales to the country accounting for 30% of India's pharmaceutical exports.

Thursday, 17 July 2014

Engineers And Head Of Accounts – Velosi Integrity And Safety Pakistan – Karachi

Description:

Engineers and Chief Accounts
Jobs for engineers


Velosi Integrity & Safety Pakistan (Pvt0 Ltd (Spanish Multinational Companies, working in Pakistan) is the inspection and supplier of engineering services and working in the field of oil and gas worldwide. Strengthen the engineering team; we are looking for young, energetic candidates for joinfast growing organization.

1. Business Development (Engineer): 02 positions (in Karachi and Lahore) 3-5 years exp in Oil and Gas Sector.

2. Inspection Engineer (LEEA-II): 02 positions (in Karachi and Lahore (3-5 years of experience (Certificate)

3. Inspectors 3.API, Various Positions - Karachi API 510, 570, 580, 653 (Certificate)

4.Lifting Inspection Engineer: Various Positions - Khi 3-5 years experience.

5. Inspection Engineer: various positions - Karachi 3-4 years experience of inspection / audit

6.Engineer: Other Positions: Process Engineer Lahore 3-5 years experience in process design). Mechanical Engineer 3-5 years of experience (Mechanical Design). Instrumentation-Engineer: 3-5 years experience in Process Plants () Mechanical Reliability Engineer 3-5 years of experience (Maintenance of Rotary Equipment). Power - Reliability Engineer: 3-5 years experience in (Petrochemical Plants, Power Generation, Distribution / Protection System).

Preferably candidate should have experience in maintenance, operations /. Support services and engineering back ground.
  • • Knowledge of different methods and techniques of reliability analysis Reliability (RCM, FMECA, Reliability Growth, etc.)
  • • in depth knowledge of NFPA, ICE and other international standards.
  • • Solid understanding RCM methodology proven by at least two plants application.

Head of Accounts 01 Position Karachi

Certified with at least 10 years experience in senior position ACCA, finalists in good standing also apply

Monday, 7 July 2014

Merger Of Moody International In Pakistan

Experience does matter - TUV AUSTRIA Office of Inspection and Certification (Pvt.) Limited - Formerly Moody International Pakistan (Pvt.) Limited



The wait is over as the business industry in Pakistan has witnessed the recent merger of Moody International (Pvt.) Limited - Pakistan TUV Austria Holding AG a company established since 1872, said the CEO of the company a leader Rashid Mehr certification and inspection. Pakistan - its renaming Moody International (Pvt.) Ltd. TUV AUSTRIA Office for Inspection and Certification (Pvt.) Limited will be further elaborated.

Moody International (Pvt.) Ltd., Pakistan began in 1997, almost no customers or brand recognition today is the main company and brand in the field of certification and inspection and ranked as a market leader in our type of industry.

Moody International (Pvt.) Limited Pakistan to be an independent company, recently for the sake of good order and decided amicably concluded with Intertek Moody Group separated.

As a result of this negotiation between the management of Moody International Pakistan and Intertek Moody Group, the company Moody International (Pvt.) Limited Pakistan became independent and 100% thereafter TUV Austria Group AG., Participation acquired Moody International (Pvt.) Limited Pakistan. The board of directors of the company approved the change of name to TUV AUSTRIA Office of Inspection and Certification, with immediate effect.

As they say experience does matter The TUV Austria AG Group's parent company is an internationally renowned brand established since 1872 with its headquarters in Vienna - Austria, one of the most beautiful capitals in the world, providing technical services and engineering high end including but not limited certification and inspection and also other 270 services internationally Dr. Reinhard Preiss said a doctorate in mechanical engineering and principal conductor of the International Board of TUV Austria Holding AG and director of the new company in Pakistan.

He also added that we are very pleased with this investment, as it is a major investment as a group have made in recent years in expanding Brand TUV Austria.

After visiting Pakistan a couple of times I and my colleagues felt that other Austrian Pakistan is really a good country, but unfortunately, a victim of perception and reality is different from what is heard through International Media. I love Pakistan and its people unrivaled hospitality and encourage all investors to use this opportunity and invest in Pakistan especiallyif want to complete their business portfolio. We are also pleased with the smooth transition from one to another in Pakistan demogratic government and people of Pakistan had we chosen the leader of their choice. Soon have a new government sworn under the table guidance of Mian Nawaz Sharif, who is known to have friendly business policies and he is very sincere to change the perception and the general situation of the country, congratulate the people of Pakistan have completed a choice successful. We believe that investing in Pakistan is very important for our future expansion plans and brand loyalty in South Asia and the Middle East.

Rashid Mehr said the company motto is quality, not quantity with HSE to be the primary factor in our business. From our initial experience with them we can tell you inhale and exhale Quality quality only. His attitude is no compromise on quality and the policy of "zero tolerance" for unethical practices and HSE.

Therefore, along with Pakistan, are now in a much stronger position than before, since we can now offer much more than before to our customers. The new ideology believes in the sky as the limit for the future growth and its customers will benefit more in terms of quality, quantity and delivery and this new venture will bring good news for existing and new customers. Since it is a known fact that already enjoyed a leading position in the market, both in the certification business and Inspection in Pakistan, with more than 3,000 customers and 200 employees throughout Pakistan, the newly merged company would like to reiterate the same position for many years to come.

Therefore, after this acquisition, customers will have access to the range of new and existing wide services. With the guarantee of quality work 100% delivered and with the new structure, the company assures its customers that except for renaming the company TUV Austria Office of Inspection and Certification, the entire team will remain intact and will the same for many years to come and this change does not affect in any way hinder the quality, quantity and delivery of services in any way currently envisaged, instead of this change will bring more energy and commitment to service thedelivery.

Tuesday, 24 June 2014

Pakistani Company Ramps Up Mango Exports To U.S.

A Pakistani exporter expects to sell 250 tonnes of mangoes to the U.S. and Canada this year.

Based in Karachi Pakistan, Farm Export Ltd. expects its shipments in North America in 2014 to be worth about $ 1 million, said Zulfikar Momin, an official Farm.

Following approval of the Department of irradiated mangoes from Pakistan Agriculture U.S., the country began exporting to the U.S. in 2011. Pakistan India and Thailand, which both started shipping irradiated mangoes to the U.S. in 2007.

First U.S. shipments Farm arrived by air June 13 in Texas. They were irradiated in the center of the USDA Animal and Health Inspection Service Animal Health in Gulfport, Mississippi, Momin said.

Early in the season, the fruit is sold in Houston and Dallas, Momin said. The company plans to expand its distribution to New York and Atlanta later in the season.

Fruit was sold at $ 25 per case, in mid-June, Momin said.

The company expects to ship by air every two weeks in August.

At the beginning of the season, Farm Sending Sindhri mangoes. Later, Anwar sent Ratols.

2,014 Expected volumes Farm would be a huge increase from 2013, when the U.S. received 8.3 tonnes of mangoes worth $ 17,000 all Pakistani sources, according to the Foreign Agricultural Service of USDA.

The U.S. imported 487,254 tonnes of mangoes worth $ 471 million from all sources in 2013.

Thursday, 5 June 2014

Compliance With RoHS 2 For Medical Devices

RoHS2 the new directive, Restriction of Hazardous Substances in Electrical Equipment, RoHS 2 (2011/65/EU) Electrical and adopted by the European Union in May 2011 is intended to replace the RoHS Directive (2002/95/EC). The new directive makes no mention of the new restricted substances, but has, however, a broader scope, affecting the documentation requirements for the performance of many companies.


NEW HEALTH PRODUCTS PRODUCT CATEGORIES

some of the new products include monitoring and control instruments and other non-electrical and electronic equipment of any other category. Although omitted above, physicians and health products In Vitro devices are now also covered by the Directive. RoHS 2 also lists restricted hazardous substances and the maximum permissible concentration in homogeneous materials as follows: Lead (Pb, 0.1%), mercury (Hg, 0.1%), Cadmium (Cd, 0.01%), Hexavalent Chromium (Cr VI, 0.1%), polybrominated biphenyls (PBB, 0.1%) and polybrominated diphenyl ethers (PBDEs, 0.1%).

AFFECTS HOW MEDICAL DEVICES?

Meets compliance 2 now refer to other medical devices such as magnetic resonance imaging equipment (MRI), computed tomography machines, equipment and X-ray July 22, 2014 is the deadline for MRI equipment machines and CT scan to demonstrate compliance with the RoHS legislation, whereas in vitro doctors and equipment chain reaction (PCR) have a time frame for compliance extended until July 22, 2017. Products implantable medical assets are not covered by RoHS standards 2 and spare parts that are already on the market before the deadlines mentioned above are excluded from compliance with the Directive.

WHAT ARE THE OBLIGATIONS OF MANUFACTURERS?

The new directive includes some changes to the legal requirements that have a direct impact on the responsibilities of manufacturers, requiring them to:

  •     Release a signed Declaration of Conformity (DoC)
  •     Technical documentation produce one record according to EN 50581:2012 or equivalent that meets the requirements of module A of Annex II to Decision 768/2008/EC
  •     OK test results of material for analysis by the IEC 62321 standard
  •     Keep the declaration of conformity and technical documentation file for a period of 10 years after the product has been put on the market
  •     Get the CE mark to demonstrate compliance with RoHS Standards 2

The CE marking now plays a dual role. This means that manufacturers are required to certify compliance with RoHS requirements not only as part of the technical documentation, but in the declaration of conformity of the EU. Consequently, the CE marking cannot be applied until the manufacturer can demonstrate compliance with RoHS 2.

In addition, an assessment of compliance, audit results / possible test results from suppliers, the use of standards and statements of compliance providers must also be provided with the technical documentation. This is why companies that were not affected by the scope of the original Directive will now have the difficult responsibility to develop and assemble all the necessary documents and avoid the risk of facing sanctions for non-compliance. The new Directive and the dual role of the brand also hits manufacturers already comply with CE RoHS, as this could involve more tests and documentation.

SGS HEALTH SERVICES CAN HELP

whatever the challenge, the team at SGS medical device is able to provide expert support of RoHS 2 compliance. As part of SGS - the parent company of verification, testing and certification in the world - we specialize in the partial and complete testing of finished products, and provide options for nondestructive testing.

Our RoHS related services for medical devices include:


  •     Complete Product and Material Testing to IEC 62321 standards
  •     Gap Analysis and Process Consulting
  •     Risk Assessment Product
  •     REACH-Annex 17
  •     RoHS Certificate of Compliance
  •     REACH-SVHC

Monday, 2 June 2014

Bureau Veritas Strengthens Its Position In US Oil & Gas With The Acquisition Of DTI

Neuilly -sur -Seine, France, June 2, 2014 - Bureau Veritas recently acquired DTI DiversiTech, Inc. (DTI), a U.S. company specialized in inspection and audit for the oil and gas sector.

Founded in 1989 and headquartered in Texas, DTI is the leading U.S. in the inspection of subsea equipment and termination used in offshore drilling operations, a market estimated at USD 150 million.

The company employs more than 85 people and generated revenues of approximately EUR 15 million (USD 20.3 million) in the year ended August 31, 2013.

DTI Bureau Veritas will strengthen its presence in the oil and gas market in the United States, particularly in the Gulf of Mexico. This region offers significant growth prospects that are driving investment in new drilling and production infrastructure.

Didier Michaud - Daniel, Bureau Veritas ' CEO, said:

" The oil and gas is increasingly using our services amid growing technological challenges in exploration and production offshore, in a stricter regulatory environment. Integration of DTI strengthens and reinforces our expertise and capabilities the situation in the U.S. technical group. "

Gerald Falls, DTI President and CEO, added:

"We are delighted to be part of Bureau Veritas. Our complementary activities enable us to offer additional services to our customers and to accelerate the expansion of DTI."

Workforce Bureau Veritas North America now reaches over 6000.

Download the press release in PDF format

About Bureau Veritas

Bureau Veritas is a world leader in laboratory testing, inspection and certification. Created in 1828, the Group has more than 64,000 employees at about 1,330 offices and laboratories in 140 countries. Bureau Veritas helps its clients improve their performance by offering services and innovative solutions in order to ensure that their assets, products, infrastructure and processes meet standards and regulations in terms of quality, health and safety, environmental protection and social responsibility.
Bureau Veritas is listed on Euronext Paris and belongs to the principal Next 20.
Compartment a, code ISIN FR 0006174348, stock symbol: BVI.

Wednesday, 28 May 2014

Merger Of Moody International In Pakistan

Experience does matter - TUV AUSTRIA Office of Inspection and Certification (Pvt.) Limited - Formerly Moody International Pakistan (Pvt.) Limited


The wait is over as the business industry in Pakistan has witnessed the recent merger of Moody International (Pvt.) Limited - Pakistan TUV Austria Holding AG a company established since 1872 , said the CEO of the company a leader Rashid Mehr certification and inspection. Pakistan - it’s renaming Moody International (Pvt.) Ltd. TUV AUSTRIA Office for Inspection and Certification (Pvt.) Limited will be further elaborated.

Moody International (Pvt.) Ltd., Pakistan began in 1997, almost no customers or brand recognition today is the main company and brand in the field of certification and inspection and ranked as a market leader in our type of industry.

Moody International (Pvt.) Limited Pakistan to be an independent company, recently for the sake of good order and decided amicably concluded with Intertek Moody Group separated.

As a result of this negotiation between the management of Moody International Pakistan and Intertek Moody Group, the company Moody International (Pvt.) Limited Pakistan became independent and 100 % thereafter TUV Austria Group AG. , Participation acquired Moody International (Pvt.) Limited Pakistan. The board of directors of the company approved the change of name to TUV AUSTRIA Office of Inspection and Certification, with immediate effect.

As they say experience does matter The TUV Austria AG Group 's parent company is an internationally renowned brand established since 1872 with its headquarters in Vienna - Austria, one of the most beautiful capitals in the world, providing technical services and engineering high end including but not limited certification and inspection and also other 270 services internationally Dr. Reinhard Preiss said a doctorate in mechanical engineering and principal conductor of the International Board of TUV Austria Holding AG and director of the new company in Pakistan.

He also added that we are very pleased with this investment, as it is a major investment as a group have made in recent years in expanding Brand TUV Austria.

After visiting Pakistan a couple of times I and my colleagues felt that other Austrian Pakistan is really a good country , but unfortunately , a victim of perception and reality is different from what is heard through International Media. I love Pakistan and its people unrivaled hospitality and encourage all investors to use this opportunity and invest in Pakistan especiallyif want to complete their business portfolio. We are also pleased with the smooth transition from one to another in Pakistan demogratic government and people of Pakistan had we chosen the leader of their choice.

Soon have a new government sworn under the table guidance of Mian Nawaz Sharif , who is known to have friendly business policies and he is very sincere to change the perception and the general situation of the country, congratulate the people of Pakistan have completed a choice successful . We believe that investing in Pakistan is very important for our future expansion plans and brand loyalty in South Asia and the Middle East.

Rashid Mehr said the company motto is quality, not quantity with HSE to be the primary factor in our business. From our initial experience with them we can tell you inhale and exhale Quality quality only. His attitude is no compromise on quality and the policy of "zero tolerance" for unethical practices and HSE.

Therefore, along with Pakistan, are now in a much stronger position than before, since we can now offer much more than before to our customers. The new ideology believes in the sky as the limit for the future growth and its customers will benefit more in terms of quality, quantity and delivery and this new venture will bring good news for existing and new customers. Since it is a known fact that already enjoyed a leading position in the market, both in the certification business and Inspection in Pakistan, with more than 3,000 customers and 200 employees throughout Pakistan, the newly merged company would like to reiterate the same position for many years to come.

Therefore, after this acquisition, customers will have access to the range of new and existing wide services. With the guarantee of quality work 100 % delivered and with the new structure, the company assures its customers that except for renaming the company TUV Austria Office of Inspection and Certification, the entire team will remain intact and will the same for many years to come and this change does not affect in any way hinder the quality, quantity and delivery of services in any way currently envisaged, instead of this change will bring more energy and commitment to service thedelivery.