Job Description
Key Responsibilities
- Lead development and implementation of SOPs for aseptic, cartridge / PFS, and isolator filling operations.
- Act as Operations owner for project-phase change controls and risk assessments. - Lead deviation investigations during commissioning, qualification, and readiness activities.
- Drive CAPA effectiveness and sustainability from Operations perspective.
- Support audits, mock inspections, and regulatory inspections.
- Strong cross-functional collaboration with QA, QC, Engineering, Validation, and Automation teams.
Qualifications
Qualifications & Experience
Education: B.Pharm / M.Pharm / M.Sc
Experience: 10–11 years in Injectable / Sterile Operations QMS
Mandatory Exposure: Cartridge / PFS manufacturing, isolator-based aseptic lines, greenfield projects
