About the role
AI summarisedAssist the manager in supervising a team to meet production targets and schedules while strictly maintaining cGMP, safety, and housekeeping standards. Perform various technical tasks compliant with cGMP, company SOPs, and safety regulations.
Life SciencesOnsite
Key Responsibilities
- Monitor production activities to ensure processes align with descriptions and SOPs.
- Accurately complete batch documentation adhering to quality and safety standards.
- Assist the Production Leader in day-to-day production activities and approve required production cycles.
- Ensure optimum allocation of personnel and equipment, liaising with associated departments regarding daily issues.
- Report and assist in investigating quality deviations and troubleshooting processing problems.
- Ensure adherence to cGMP and GDP (Good Documentation Practice).
- Approve and closeout safety work permits.
- Provide oversight during preventive and breakdown maintenance, including Operations oversight of CM/PM/Calibration activities.
- Lead Continuous Improvement activities as assigned to enhance Quality and Efficiency.
- Operate pharmaceutical production equipment (e.g., high-speed filling lines, Autoclave, depyrogenation tunnel) as per SOPs and Batch Record.
Requirements
- Strict adherence to cGMP and GDP throughout all tasks.
- Ability to perform formulation activities, including dispensing Drug substance(s) and excipients, as per SOPs.
- Proficiency in performing materials and process (SAP) transactions at each manufacturing step per SOPs.
- Strictly follow aseptic techniques for aseptic operations when required.
- Ability to perform routine QC sampling and in-process testing (e.g., bioburden, water sampling) if required.
- Willingness to perform chemical/mathematical calculations for potency and endotoxin levels if required.
- Maintain strict compliance with all SOPs and report quality issues immediately.