Job Description
- Develops and implements visual inspection procedures, including SOPs and work instructions, for manual, semi-automatic, or fully automatic systems inline with SOP/ Regulatory requirements.
- Ensure Visual inspection is being performed as per respective SOP.
- To ensure availability of sufficient VI inspector as per process requirements.
- Good hands-on KNAPP kit preparation & qualification activity.
- Ensures all products adhere to quality, safety, and regulatory standards (e.g., FDA, EMA, ICH).
- Hires, trains, and manages inspectors, ensuring high-performing, compliant, and motivated staff.
- Monitors inspection processes, analyses data for trends, and initiates corrective actions (CAPA) or process improvements.
- Collaborates with Engineering to validate equipment and maintain inspection limits.
- Collaborates with SCM, MFg. to plan VI activity to meet business requirements.
- Prepare & Reviews batch records, deviation reports, and face internal/regulatory audits.
- Compliance of audit observations.
Skills Required
- Good Manufacturing Practice (GMP)- Expert
- Regulatory Compliance- Expert
- SOP and Document Review & Approval - Expert
- Handling of packing and visual operations- Expert
Qualifications
Educational qualification: B.Sc./ M.Sc./B.Pharm,
Experience: 08 to 12 years in injectable/ sterile packing
Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.
