Head - Quality Assurance (Biologics)

We have job opportunity with leading pharmaceutical company for Head Of Quality Assurance based in Gujarat.

Key Responsibilities:

· Establish SMART objectives, roles and responsibilities and define Key Performance Index (KPIs) to evaluate Quality function

· Lead design and upgrade of Quality Management systems and processes to enhance current Quality Systems in line with Corporate Quality Policy

· Establish & execute a strong documentation Review/Authorization process of all GMP Documents. Review and approve Specifications, Standard Testing Procedures, Artworks, Protocols/ reports of Process Validation, Cleaning Validation, Instrument/Equipment Qualification Document and Stability Study Protocols. Manage, review and ensure compliance as per all Apex documents.

· Oversee IPQA and engineering activities and ensure compliance

· Align & work seamlessly with functions in other domains including Plasma Procurement, Research & Development, Cold Chain Operations, Engineering, etc. to establish a Quality driven culture for achieving business goals

· Co-host inspections and audits and manage auditor queries when required during regulatory audits to ultimately accomplish approval for products

· Report updates and progress on a weekly basis that includes resolve and/or escalate issues. Initiate and champion project teams to aggressively resolve urgent and important issues in Quality Operations

· Support and monitor progress on discrepancy investigation, CAPAs raised during internal and external audits. Drive investigations and monitor reporting in the event of incidents, market complaints, returns and recalls

· Prepare/ guide preparation of CAPEX requirements highlighting the need for creating/expanding a facility, the potential, the scope, etc.; seek approval from Operations head / BU head for Expansion projects

· Recommend design / equipment/ technology required for the plant to respective stakeholders

· Manage Quality team performance via HR processes, train and mentor/develop talents to the highest standards while actively recruiting external talents to fill internal gaps and expansion needs

· Identify continuous improvement opportunities, coach & mentor teams to build a culture of high performance.

Qualifications & Additional Experience:

· The position requires a PhD. / MS/ MSc. / M Pharm. degree or equivalent in a science or health care field with a preferred focus on biochemistry, microbiology, chemistry, or equivalent science program.

· Minimum of 15 -20 years of experience in GMP focused Pharmaceutical &Biologics (minimum work experience of 3 years mandatory in Biologics)

Note: If interested, please contact to Priya Narvekar 02266500718/pt@factjobs.com