GM - Quality Assurance - Vaccines/Pharma

- Demonstrate Comprehensive leadership and management of Quality Management System (QMS)

- Design & demonstrate strong and visible support for the QMS and ensure its implementation at manufacturing sites.

- Lead and build Empowered QA Teams and provide them continuous support in achieving quality output.

- Oversee the quality assurance operations and ensures that products are manufactured, tested released in a way that takes account of the requirements of cGMP and other regulatory requirements.

- Strong understanding of Fermentation, master cell banking, aseptic work including disinfectants effectiveness, autoclaving, QC biological testing, cross contamination concerning live banking/viral material , GMP, media fills, sterility testing.

- Strong drive to lead site QA operation with sound understanding of Regulatory Audits and Self Inspection, Quality Policy, Deviation management, CAPA system, Validations, Training Management Systems, Complaint Management System, Risk Analysis & Mitigation and associated operations.

- Experienced to deal with foreign consultants & inspectors.

- Knowledge of current Good Manufacturing Practices, quality systems and quality assurance is required, along with working knowledge of manufacturing process steps and quality control for biologics product manufacturing, aseptic filling, utilities, and facilities.

- Sound technical skills including working knowledge of biologics and pharmaceutical production, quality assurance, and testing technologies.

- Experience complying with international regulatory standards.

- Experience with contract operations and implementation of quality systems

- Ability to diplomatically enforce Quality expectations.

- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

- Strong commitment to individual and team development with particular emphasis on delivery of Quality Training.

- In ensuring that processes are established for capturing, documenting, communicating and measuring delivery against all customers’ requirements.

- Timely completion projects.

Qualification

- M.Sc. and Ph.D. Biotechnology/Biochemistry/Microbiology/

- Chemistry/Life Sciences/related field

Experience : Minimum 12 to 18 years of relevant experience in pharmaceutical sterile bulk antigens (Biologicals)

Preferred Industry – Any reputed Biotechnology organization