Job for M.Sc. - Microbiology/ Biotechnology/M.Pharma as Sr. Manager – Quality Assurance in Panacea Biotec

Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Post: Sr. Manager – Quality Assurance

Job Description:

To laydown Quality Assurance system to ensure cGMP/ cGLP compliance at Plant/Quality control department as per quality standards.
To authorize /Approve the Standard Operating procedure, Validation protocol and reports, stability testing protocol and reports, specification etc.
To approve or hold or reject the finished product, in process bulk, final bulk, inactive raw material or active raw material.
To approve or reject the request the request for issuance of batch Processing record from production
To ensure implementation, and when necessary revision of documents like standard operating procedure, Site master file, Validation Master Plan, Calibration planner, Validation protocol, and reports, stability testing protocol and reports, specification etc.
To co-ordinate with other departments for audits by the external agencies and regulatory authorities.
To control distribution, retrieval, archival, destruction and storage of quality documents.
To evaluate the performance of subordinates.
To ensure the material and products are stored in appropriate storage condition
To ensure the vendor approval and approval of contact manufacturing sites as per approved procedure.
To ensure the completeness and correctness of CDL summary protocol
To ensure proper training to all personnel’s.
To ensure all IPQA activities pertaining to vaccine formulation
To ensure the release of CDL released batch of product.
To coordinate with Q&C and RA for filling of dossier and PFS.
Personnel’s from Biological Operation with vaccine background having good exposure of GMP environment are preferred.

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Additional Information:
Experience: 12-15 Years
Age: 30-38 years
Location: Baddi
Education: M.Sc. - Microbiology/ Biotechnology/M.Pharma
Industry Type: Pharma/Biotech/Vaccines
Functional Area: QA
Last Date: 27^th Sep., 2013