Our client is one of the fastest growing Biopharmaceutical clients based in Hyderabad.

Job Purpose: The QA Head will lead and deliver Quality and Regulatory Affairs across our biopharmaceutical manufacturing plant, including bulk production, formulations, QC, utilities, and more.

Reporting to: MD

Job Profile:

- Lead and deliver Quality and Regulatory Affairs across the plant, covering bulk production, formulations, QC, utilities, and more.

- Set up systems, processes, procedures, conduct internal audits, file dossiers, and oversee all the quality procedures relevant to various international markets.

- Lead international audits like USFDA/EMEA/ANVISA, etc.

- Prepare and Review QMS documents like SOPs, Change Control, Deviations, CAPA, etc.

- Handling of Deviation Management, Market Complaints, OOS/OOT, Failure Investigation and CAPA and Change Management

- Vigilance of all manufacturing and packaging operations to ensure shop floor compliance & All-Time Readiness (ATR)

- Review of Batch Production Records and batch release and related logbooks.

- Inventory management of QA department.

- To conduct and monitoring of Process validation, Process verification, cleaning validation, and Hold time study of various products.

- To review Master documents like Batch manufacturing records and Batch Packing records.

- Review of SOP's, STP's and product validation reports.

- Review of Master & Executed Batch Manufacturing/Packaging documents.

- To co-ordinate and provide necessary support for ANDA submission to Regulatory Affairs.

- Review and Approval of Process validation and Cleaning Validation protocol and Report.

- Handling of all regulatory & customer audits.

- Preparation and submission of compliance reports.

Candidate Profile:

- Education: MSc/ M. Pharma/ M. Tech in Biotechnology/ Microbiology/ Chemistry or related field.

- Relevant experience of about 15-20 years in a biopharmaceutical manufacturing company.

- Experience in automation and compliance is a must.

- Experienced in handling multiple international audits of USFDA/EMEA/ANVISA etc is a must.

- Strong interpersonal and analytical skills,

- Knowledge of biological processes and bioproducts.

Note: Due to the paucity of time, only shortlisted candidates will be connected.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.