JOB SUMMARY
The Production Associate is responsible, under the authority of the Production Manager, for documenting, following up on investigations, continuous improvement projects and the implementation of data integrity at departmental level.
JOB RESPONSIBILITIES
1 Specific to the job
- Monitor and apply the systems set up to investigate any deviations detected that may impact the quality of manufactured products prior to batch release, in accordance with Pfizer quality standards and regulatory requirements:
- Processing of production investigations
- Processing of investigations linked to complaints received from external customers .
- Monitor, review and approve investigations.
- Follow-up, review and approve commitment tracking and CAPAs resulting from investigations.
- Preparation and communication of monthly or quarterly quality metrics to monitor the performance of quality functions.
- Participate in internal and external audits.
- Creation of change controls and follow-up of actions.
- Implementation of data integrity plan and action tracking, reconciliation, paper control, backup and restore, alarm management and audit trail ...…
- Ensure DI assessment for new equipment acquisitions
- Follow-up of continuous improvement projects and lead progress
2 EHS responsabilities
- Comply with Pfizer, regulatory and other requirements (EHS policy, instructions, etc.)
- Actively participate in the hazard identification and risk control program by proposing EHS ideas,
- Propose projects to improve EHS metrics
- Notify management of any actual and/or potential non-conformities (active reporting).
Qualification and Preferred Requirements:
- Master degree in biology or eqyuivalent
- min 2 years experience in pharma industry , ( in Quality assurance for example)
- Strong analytical and problem-solving skills
- Proficiency in using manufacturing software and systems
