Senior Executive

6 days ago

Ahmedabad, India Fact Personnel Full time

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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