Role Accountabilities
- Lead, mentor, and motivate the CQA Investigation team to meet company goals, maintain safety standards, and ensure high performance.
- Allocate investigation activities to the team, ensuring adherence to approved procedures and regulatory standards.
- Oversee the corporate investigation team’s participation in critical investigations across GMP, GLP, GCP, Discovery, and Development verticals, ensuring depth and adequacy.
- Monitor closed investigations for compliance and adequacy in all verticals (GMP, GLP, GCP).
- Ensure continuous improvement of investigation processes in line with regulatory expectations.
- Train and qualify the personnel involved in the investigation across GxP verticals.
- Establish, monitor and maintain the investigation governance and excellence program across GxP verticals.
- Investigation of Data Integrity incidents, if any, and resolution.
- Conduct internal audits as a Subject Matter Expert for OUs and provide audit support.
- Ensure adherence to safety work standards and SOPs during investigation activities.
- Review and approve change controls, risk assessments, CAPAs, and SOPs.
- Present data for Quality Management Review meetings as required.
- Ensure timely completion of team training and qualification requirements.
- Provide training on investigation adequacy and related topics to the CQA team and other relevant stakeholders.
- Identify team development needs and create personalized development plans.
- Handle regulatory and client audits, support internal audits, and ensure compliance with KPIs.
- Liaise with department and OU heads to address risks identified in audits and ensure timely closure of QMS actions.
- Collaborate with site quality and manufacturing teams to resolve compliance issues.
Experience:
- About 16+ years of work experience in the pharmaceutical or biotech industry or CDMO sector.
Skills and Capabilities
- Technical knowledge in API, Biologics, and Formulations.
- Should have minimum 16 years of work experience in Pharmaceutical or biotech industry or CDMO sector.
- Life Science QMS procedures.
- Interpersonal skills to establish collaboration with cross-functional teams.
- Establish good Interpersonal skills with cross-functional teams.
- Capable of thinking scientifically to address complex problems and develop solutions.
- Work as a team and have a collaborative mindset.
- Good communication skills
Education
- M.Sc / M. Pharm/ B. Pharm/ MTech/B.Tech.
Apply: https://careers.syngeneintl.com/job/Bangalore-Corporate-Investigation-Lead/1250279100/