Role: Senior Quality Assurance Specialist

Location : Bengaluru

Position Summary : The Senior Quality Assurance (QA) Specialist has operational responsibility of policies, procedures, and documentation to maintain compliance and alignment with current regulatory guidance and regulations. The ideal candidate is one who is a self-starter, with the goal of maintaining a robust Quality Management System (QMS) for a GMP Pharmaceutical Production Facility. The Senior QA Specialist's role is expected to provide high quality work product in a timely manner

Key Duties & Responsibilities:

- Review of batch records, Certificates of Analysis (CofA) and other Quality related documentation

- Create and revise quality assurance policies and procedures.

- Work collaboratively with other departments to conduct deviation investigations and write reports.

- Provide QA review of excursion/non-conformances, deviations, OOT, OOS, and CAPA Reports.

- Track and trend Key Performance Quality Indicators (KPQIs)

- Review and approve method transfer, specifications, validation protocols, and summary reports.

- Review and approve supplier, service provider, and subcontractor surveys.

- Assist in customer audits, regulatory inspections and conduct internal audits.

- Participate in preparation of response to client audit and regulatory inspection.

- Serve as Quality representative on assigned client projects.

- Understand and apply ICH, USP, FDA, EU and ISO standards and guidance effectively.

- Train and provide mentorship to co-workers as needed

Education:

Minimum of B.Sc / M.Sc. degree in a physical science discipline (preferably Chemistry or Biochemistry) or PhD Experience 7+ years of applicable industry experience Preferred: M.Sc degree in a physical science discipline (preferably Chemistry or Biochemistry) with 5+ years of applicable industry experience. PhD with 3 years of experience GMP Exposure and auditing experience preferred. Preferred certification such as CQA from ASQ

Functional/Technical Competencies & Skillsets:

- Must be proficient in reviewing executed batch records, and data associated with a variety of analytical techniques including, but not limited to, analytical balances, pH meters, HPLC, LCMS, GC, GCMS, FTIR, UV/Vis spectroscopy, and moisture analysis by Karl Fischer.

- Demonstrate skills to review data packets for technical and regulatory compliance errors.

- Demonstrate skills to write scientifically sound investigations of deviations and OOS events.

- Demonstrate ability to effectively follow good documentation policies.

- Must be willing to work both independently and as a team player with a positive attitude.

- Detail-oriented mindset with excellent critical thinking, multi-tasking, and organizational skills.

- Clear, effective, and professional communication with colleagues, clients, and contractors

- Effective time management strategies to ensure work is performed within required timelines

- Stay current with pharmaceutical industry regulatory requirements and standards