:
• Development and update of Batch Manufacturing Records (BMRs) with guidance from MS&T Technical Transfer (TT) and Technical Specialists.
• Support technical CAPAs that require SOP development, authoring and delivery of associated training.
• Technical BMR data logging and compilation to support Continued Process Verification (CPV) analysis and reporting.
• FMEA authoring and facilitation; document outputs and ensure resulting actions are captured and tracked.
• Training outline development and team training administration (scheduling, materials, records).
• Support technical transfer phases by translating process design information into compliant operational documentation (BMRs, SOPs, forms, logbooks).
• Witness key trials and studies to establish which documents and sections require updating, coordinate review and approval of updates.
• Maintain accurate documentation records within the electronic documentation management system, including version control and change control, ensuring data integrity and audit readiness.
• Provide proficient data entry and spreadsheet management support for trackers, logs and trending dashboards used by MS&T.
Minimum Requirements/Qualifications:
To thrive in this role, you should possess the following qualifications and experience:
• Proven working knowledge of Good Manufacturing Practice (GMP) principles for manufacturing documentation and data integrity requirements.
• Experience (typically 3+ years) in pharmaceutical manufacturing or technical services (, MS&T, technical transfer, validation or operations), ideally within sterile drug product manufacturing.
• Demonstrated experience authoring and revising BMRs/MBRs and SOPs, and supporting technical CAPAs, change controls and training delivery.
• Strong analytical, data entry and spreadsheet skills (, Excel) to maintain CPV logs, trackers and trending.
• Familiarity with risk management tools such as FMEA and confidence facilitating cross-functional sessions.
• Experience working with electronic documentation management systems.