Quality Assurance Specialist 3rd Party Products PCI Pharma Services

2.0 - 6.0 years

0 Lacs

rajasthan

On-site

Your role at PCI as part of the Batch File Review Team will involve compiling and reviewing batch documents across various process types such as OSD, Sterile, Biologics, Cell Therapy, and Gene Therapy. You will collaborate closely with internal and external stakeholders, preparing documentation for Quality Person (QP) review, coordinating corrections, and ensuring compliance with regulatory requirements. This position offers a diverse range of responsibilities and serves as an ideal foundation for those considering a future career as a QP. Key Responsibilities: - Compile and review batch documents, ensuring accuracy and completeness prior to QP review. - Collaborate with site personnel to ad...

Posted 3 days ago

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Sr Scientist - Cell Therapy Aurigene Oncology Limited

5.0 - 9.0 years

0 Lacs

karnataka

On-site

As a highly skilled professional with a Ph.D. specializing in Immunology or Immuno-oncology and possessing 5-6 years of experience in academia and/or industry, you will be responsible for developing new cell therapy products. This includes conducting Process Development and validations to advance the product to the next stage. Your role will involve analyzing existing processes to identify areas for improvement, designing and developing new processes, and implementing them to enhance efficiency and productivity. Additionally, you will be tasked with scaling up the production process for seamless tech transfer to the GMP scientists. Your extensive experience in developing process documentatio...

Posted 3 weeks ago

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Analytical Analyst People Partner Talentsutra

2.0 - 4.0 years

6 - 13 Lacs

faridabad

Work from Office

Develop and optimize functional assays for CAR-NK and CAR-T cells; perform in vitro characterization, QC testing, and data analysis; support assay transfer and scale-up in compliance with regulatory standards.

Posted 1 month ago

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Facility and Operations Manager Randstad

10 - 15 years

18 - 25 Lacs

Navi Mumbai

Work from Office

Role & responsibilities: Lead, manage, track, and ensure the timely completion of Quality Management System (QMS)-related documents, Standard Operating Procedures (SOPs), and other departmental paperwork. Ensure the facility operates in full compliance with GMP requirements. Ensure compliance with EHS (Environmental Health & Safety) standards. Lead all aspects of facility operations, including cleanroom maintenance, equipment qualification, and environmental monitoring. Ensure all systems (HVAC, BMS, water systems, etc.) are functioning within validated parameters. Work closely with QA, Validation, and Engineering teams to support new installations, expansions, or requalification efforts. Di...

Posted 4 months ago

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