Long Description
- Execute and supervise filling and formulation area operations in accordance with approved SOPs and defined inspection standards.
- Maintain accurate, real-time documentation in BMR/BPR, equipment logbooks.
- Execute and supervise training of operators on aseptic operation and practices
- Ensure strict adherence to approved SOPs.
- Ensure discipline, proper gowning compliance, and acceptable cleanroom behavior in the classified area.
- Ensure compliance with data integrity (ALCOA+) principles throughout documentation activities.
Competencies
Education
Graduation in PharmacyPost Graduation in Biotechnology
Work Experience
Minimum 2 to 4 years of relevant experience in filling and formulation of sterile injectable Vial and PFS products, along with proven experience in handling and facing regulatory audits.
