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6 Oos Investigations Jobs

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5.0 - 10.0 years

0 Lacs

amritsar, punjab

On-site

As a QA Manager at Systacare, a trusted name in the pharmaceutical industry, your primary responsibility will be to ensure adherence to regulatory requirements and maintain the highest standards of compliance in injectable manufacturing. With a strong focus on innovation, compliance, and patient safety, Systacare is expanding its team and is seeking passionate professionals to join the organization. You will lead and manage the QA team to ensure compliance with cGMP, regulatory standards, and company SOPs. Your role will involve overseeing quality systems, including deviation management, change control, CAPA, OOS, and OOT investigations. It will be crucial for you to ensure quality assurance...

Posted 1 week ago

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3.0 - 7.0 years

0 Lacs

rajkot, gujarat

On-site

You will be responsible for writing and proposing revisions to Standard Operating Procedures, Analytical Methods, Lab Reports, and related Forms. You will perform reviews to support Validation, Document Control, and Change Control systems. Additionally, coordination and maintenance of the stability program for new product development and existing products will be under your purview. Tracking and reporting on Quality System Metrics relevant to testing, OOS Investigations, and training to support Quality Systems Reporting is also a key aspect of this role. Furthermore, you will provide QA Support for Audits and Inspections. To be considered for this position, you must have an M.sc in Microbiol...

Posted 2 weeks ago

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2.0 - 6.0 years

0 Lacs

andhra pradesh

On-site

The responsibilities and duties of this role include: - Performing sampling and analysis of Raw materials, Packing materials, In process, Intermediate, and Finished products. - Conducting calibration of Quality Control instruments. - Carrying out Stability/Holding time studies. - Managing Reference Standards and qualifying Working Standards. - Ensuring Analyst qualifications are met. - Conducting Analytical Method Validation. - Managing Control samples (Retain sample). - Conducting OOS investigations (Phase-1). The ideal candidate should have: - 2-3 years of experience in Pharmaceutical Quality Control. - Educational background in M.Pharmacy/B.Pharmacy/M.Sc. (Chemistry)/B.Sc. (Chemistry). - ...

Posted 2 weeks ago

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10.0 - 15.0 years

0 Lacs

karnataka

On-site

As a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd, you will be responsible for overseeing the Gamma Irradiation of Sun Pharma products at third-party gamma irradiation sterilization sites. Your primary role will involve supervising the sterilization process, monitoring the irradiation of batches, and ensuring compliance with quality assurance regulations and auditing techniques. Key responsibilities include: - Demonstrating a sound understanding of pharmaceutical manufacturing processes for both non-sterile and sterile formulations. - Supervising the Gamma sterilization site used for sterilizing drug products and components. - Monitoring the receipt and dispatch of ...

Posted 1 month ago

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3.0 - 8.0 years

5 - 10 Lacs

Medak

Work from Office

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for metho...

Posted 3 months ago

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2.0 - 6.0 years

3 - 5 Lacs

Medak

Work from Office

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC. Responsible for allotting the work to the chemist within the raw material section. Responsible for performing the calibrations of all instruments in raw material section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents,...

Posted 3 months ago

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