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Quality Control - API

Keywords / Skills : QC, QC Chemist, Quality Control, Quality Control Executive

1 - 5 years
Posted: 2018-10-17

Pharmaceutical/ Biotechnology
0.00 - 4.00 lacs
Posted On
17th Oct 2018
Job Description
• Raw material, In Process samples and finished product inspection/ testing/ approval.

• Production process control in coordination with Production.

• Product traceability - Reserve Samples.

• Customer complaints relating to quality of the product.

• Identification recording and evaluation of all Nonconforming products.

• Corrective and preventive actions as and where applicable.

• Adherence to Product Specifications and Good Laboratory Practice

• Maintenance and Calibration of Measuring and Testing Equipment/ Instrument belonging to the Quality Control Laboratory in coordination with Maintenance Department.

• Preparation/ Review and maintenance of Product specifications, Analytical reports and Quality Records.

• Review of cleaning validation/ Process validation protocols.

• Issue of Raw data book/ Checklists/ log sheets for record entries.

• Updation of Stability protocols and calibration records of all Laboratory Equipment/ Instruments.

• Investigation of OOS results.

About Company

Biocon is Asia’s premier biopharmaceutical company that is driven by the vision to make a difference to global healthcare through improved access to high quality, life-saving biotherapeutics by making them affordable for patients across the world.

We have evolved from manufacturing pharmaceuticals like statins and immunosuppresants, to discovering, developing and producing biologics in chronic therapies such as diabetes, oncology and immunology for global markets. This has translated into a diversified and differentiated pipeline of fermentation-derived complex generics, biosimilars that include insulins and monoclonal antibodies, and novel biologics.

Biocon is among the few companies globally to have received approvals for its biosimilars from developed countries like the U.S., EU, Australia and Japan. Our credibility as a serious player in the biosimilars sector was first established with the Japanese approval for Insulin Glargine. The credibility was enhanced when Biocon, along with partner Mylan, became the first globally to get biosimilar Trastuzumab and Pegfilgrastim approved in the U.S. in 2017 and 2018, respectively. We were also among the first few to receive Insulin Glargine approval in Europe and Australia for Insulin Glargine, both in partnership with Mylan. We have also established our presence in key emerging markets through safe, effective and high quality biosimilars including recombinant human insulin.

A combination of specialized talent, state-of-the-art research and manufacturing infrastructure and a culture of deep science and regulatory compliance have differentiated us in the marketplace and given us a distinct competitive edge. It has also led to Biocon being recognized as a credible global biopharmaceuticals player.
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