Quality Assurance Sr Specialist [Production Support]
Teva Pharmaceuticals View all jobs
- Żejtun, Malta Island
- Permanent
- Full-time
- Issue manufacturing and packaging documentation, including sample labels, in compliance with cGMP and production plans using ERP and EDMS systems, ensuring no operational delays.
- Issue production and warehouse logbooks as required.
- Review manufacturing and packaging documentation, as well as electronic batch reports in MES, ensuring compliance with cGMP and timely processing.
- Perform inspection lot usage decisions, results recording, and approvals within ERP and MES systems.
- Compile and analyze data required for reporting and process verification following batch review.
- Review contract manufacturing batch documentation and approve it for packaging processes in ERP systems.
- Create and update Manufacturing Master Batch Records in EDMS and MES.
- Review and approve Packaging Master Batch Records in EDMS, including PVL (Parameter Value List) and PMBRS (Packaging Master Batch Records) in MES.
- Compile assigned Product Quality Reviews on a monthly basis.
- Deliver and maintain training on new and updated Standard Operating Procedures (SOPs), ensuring compliance at all times.
- Maintain up-to-date training records on the company's training platform.
- Report deviations from approved SOPs and support investigations related to documentation, quality, or production issues.
- Participate in continuous improvement initiatives and cross-functional projects.
- Support the QA Technical Coordinator in problem-solving, cost reduction, and efficiency improvement initiatives.
- Perform additional duties as assigned.
- O-Level standard of education (mandatory) with relevant experience in the pharmaceutical industry.
- A-Level or Diploma qualification is considered an asset.
- Strong attention to detail and accuracy
- Effective communication and organizational skills
- Proactive, reliable, and results-driven
- Proficiency in Microsoft Office applications
- Ability to work under pressure and meet deadlines
- Strong teamwork and collaboration skills