
Operations Specialist
2 weeks ago
The role of Manufacturing Operations Specialist is available at a Pharmaceutical organisation.
Responsibilities include all procedures and processes associated with the manufacture of Commercial Large-Scale Drug Substance at the manufacturing facility.
Key tasks involve preparation, operation, and monitoring of equipment, use of business systems, and carrying out tasks including but not limited to cleaning, validation, in-process testing, and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).
- Work collaboratively with the manufacturing operations group, project design team, the CQV team, and the Automation/CSV reps to facilitate the development and validation of the manufacturing facility.
- Support Equipment Design/HAZOP and Room programming reviews.
- Collaborate with the Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance, and team training.
- Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
- Generate SOPS/Electronic Batch Records.
- Adhere to Right First-Time principals.
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