The role provides daily operational support to the Process Coordinator. The technician will focus on manufacturing, filling, inspection, and packing pharmaceuticals (both sterile and non-sterile). They will follow Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs), ensuring compliance with cGMP (current Good Manufacturing Practices).
What will you do?
Responsibilities:
* Operation & Manufacturing: Set up and operate bulk formulation, filling, inspection, and packing lines, ensuring correct processes for both sterile and non-sterile products.
* Quality Control: Complete batch documentation accurately, perform in-process checks, and ensure compliance with SOPs to maintain high-quality standards.
* Equipment Maintenance: Perform equipment checks, cleaning (including CIP and SIP activities), and report any issues.
* Operational Support: Assist with project validation, new product introduction, SAP transactions, and work with quality systems for GMP changes.
* Leadership & Team Support: Monitor team progress, track downtime, ensure accurate batch records, and provide leadership in the absence of the Production Coordinator.
GMP Responsibilities
* Ensure all processes (manufacturing, filling, inspection, and packing) comply with GMP.
* Support deviations and investigations and carry out good manufacturing practices.
* Maintain a tidy and compliant environment.
EH&S (Environment, Health & Safety) Responsibilities
* Follow emergency procedures and ensure safe work systems are adhered to.
* Report accidents, near misses, and breaches of safety protocols.
Who we are looking for:
Minimum Requirements/Qualifications:
* Experience in a pharmaceutical or regulated environment (MHRA and FDA regulations).
* Knowledge of clean room operations and aseptic manufacturing.
* Strong English and Math skills; a scientific background is crucial (e.g., A-Levels).
* Previous supervisory experience or ability to develop individuals.
* Lean systems and continuous improvement experience (Green Belt preferred).
* Understanding of pharmaceutical systems with HMI involvement.
* Aseptic block license (if required).
Work Schedule:
24/7 shift pattern
Working environment:
Good Manufacturing Practices (GMP) ; cleanroom environment
Environmental Conditions:
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
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