Brunel
Responsibilities
Support Pharmaceutical Quality Systems after project implementation – R&D Quality
- Continuous Quality Improvement projects for the Pharmaceutical Quality System, specifically documentation flow, review process and SAP transactions for new process for media manufacture outsourced to VIA. The process will be mapped, with clear identification of inputs, outputs, timeline, and roles & responsibilities for all parties involved
Evolve Quality Systems support model for Plan to Manufacture project implementation, specifically for R&D
- Update Shop Floor Quality, QTP and Batch Release procedures for clarity, including additional transactional and process steps, for S4/HANA transactions
- Develop and draft procedures for master data governance for R&D, specifying accountabilities for R&D Quality, VIA, and R&D partners
Quality Documentation reviews required for projects execution and milestone delivery
- Executed Media batch record review throughout the term
- Sterilization record reviews throughout the term
- Facility cleaning logbook reviews throughout the term
- Document updates for Operational Quality
- Gap assessments of procedures against Global Quality Standards
SAP S4/HANA transactions
- Master data reviews in SAP
- Routine operational transactions (e.g., stock posting and usage decisions)
- Review of master data requests
- Change control documentation for master data requests
- Issue resolution and tracking and administration
To apply for this job please visit www.brunel.net.
