Formulation Operator (Pharmaceutical Manufacturing)

Job summary

This role involves supporting the Drug Product Manufacturing facility by executing formulation processes in compliance with GMP standards. The position is crucial for ensuring high-quality production and operational improvements.

Qualifications

• Proactive and positive mindset, capable of working independently and in teams.
• Experience as an operator in aseptic pharmaceutical manufacturing or a similar GMP-regulated environment.
• Strong understanding of GMP requirements, aseptic techniques, and cleanroom behavior.
• Flexibility to adapt to changing tasks and shift patterns.
• Proficient in reading, writing, and speaking English.

Responsibilities

Working Hours

• Execute formulation processes according to the production plan and customer programs.
• Conduct documentation activities ensuring compliance with Good Documentation Practices (GDP) and GMP.
• Support batch review and documentation, identifying deviations and suggesting improvements.
• Collaborate across departments to optimize workflows and minimize downtime.
• Participate in tech transfer activities, equipment qualification, process validation, and Aseptic Process Simulation (APS).
• Maintain cleanroom standards within the facility.
• Contribute to enhancing safety, quality, reliability, and efficiency in the department.
• Initially scheduled during regular daytime hours, transitioning to fixed shifts as operations expand.

Tools

• Familiarity with standard operating procedures (SOPs), work instructions (WIs), and manufacturing batch records (MBRs) in English.