Purpose Statement

• Ensure operational efficiency and compliance by managing technical documentation, addressing non-conformances, and implementing corrective actions.
• Streamline processes and drive continuous improvement across manufacturing operations.
• Effective change management, thereby fostering process enhancements and ensuring compliance with regulatory standards. 

Operations and Technical

• Conduct technical writing and collaborate with Operations and cross-functional team to investigate non-conformance issues.
• Develop and implement corrective and preventive measures together with the Operations team and cross-functional team.
• Manage change processes to enhance operations.
• Develop and conduct training modules for Operations and new employee onboarding.
• Analyze key performance indicators and execute strategies to optimize workflows.
• Author and revise GMP-related documents.
• Collaborate on the creation, revision, and enhancement of electronic batch records.
• Lead or participate in projects aimed at enhancing operations or new product introduction.
• Utilize quality management systems and operations-related software, such as Trackwise, LIMS, SAP, POMSnet, Delta-V or others.
• Prepare and support regulatory inspections and internal audit.
• Engage in projects aimed at continuous operational improvement.
• Engage in regular GEMBA walkdowns.
• Organize regular meetings with cross-functional teams to discuss and update daily operational matters.

Safety

• Ensures a safe work environment by adhering to regulatory and global/local Environmental, Health, and Safety (EHS) policies.

Quality

• Ensure investigations are conducted and completed promptly and to a high standard.
• Ensure that process improvements are relevant and beneficial to the manufacturing operations.
• Verify the accuracy of impact assessments and ensure corrective and preventive actions are relevant.
• Serve as point of contact for change management documentation and investigations during audits and inspections.

Schedule

• Strive to complete investigations in a timely manner to minimize any potential impact on batch release timelines or shipment schedules.
• Ensure that process improvement changes are executed on schedule as planned for the production run.