Job Description
Key Responsibilities
- Preparation and implementation of SOPs, STPs, formats, and records for injectable operations including cartridge / PFS and isolator-based filling lines.
- Execution of document control activities including issuance, revision, and archival.
- Initiation and tracking of change controls related to facility, equipment, utilities, and documentation.
- Support deviation documentation and investigations during commissioning and qualification phases. - Support CAPA implementation and tracking.
- Cross-functional coordination with QA, QC, Engineering, Validation, and Projects teams.
Qualifications
Education: B.Pharm / M.Pharm / B.Sc / M.Sc
Experience: 7–8 years in Injectable / Sterile Operations QMS
Preferred Exposure: Cartridge / PFS manufacturing and isolator-based aseptic filling lines
