Senior Executive
3 days ago
Role & responsibilities
- Operate and manage freeze drying and lyophilization equipment, including Freeze Dryer, Palltronic Integrity Tester, and CLU.
- Ensure smooth functioning of computerized systems such as eBMR, PLC, SCADA, and manage data integrity, audit trails, and system backups.
- Participate in equipment and area qualification/requalification activities, including LAF (Laminar Air Flow) systems.
- Ensure adherence to and documentation of Change Controls, Risk Assessments (RA), Corrective and Preventive Actions (CAPA), and EHS (Environment, Health, and Safety) protocols.
- Ensure compliance with regulatory standards and assist during audits and inspections.
- Maintain accurate and timely documentation as per GMP guidelines.
Preferred candidate profile
- Bachelors degree in Pharmacy (B. Pharma) – Mandatory
- 4 to 7 years of experience in a sterile pharmaceutical manufacturing environment, specifically in Lyophilizer operations.
- Strong understanding of pharmaceutical regulatory standards, including GMP, FDA, MHRA, etc.
- Familiarity with automation and computerized systems like eBMR, SCADA, PLC.
- Sound knowledge of qualification protocols, equipment handling, and process controls.
- Excellent documentation and communication skills.
- Proactive, team-oriented mindset with the ability to handle audits and cross-functional coordination.
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