The candidates will provide a quality support to the Quality Systems, Operational Quality and Technical Quality teams as required.
- Provide Quality Operations support to approved vendors and ensure that any risks are communicated effectively.
- Review pharmaceutical product batch files for timely release by Responsible Person (RP) or certification by Qualified Person (QP).
- Provide QA support to the business during root cause analysis investigation
- Raise in a timely manner on request or using own initiative Third party notification, CAPA, Deviation and Change Control.
- Support activities required to effectively maintain the company Pharmaceutical Quality System
- Monitor alerts for potential overdues for Complaints, CAPA, Deviation and Change Control.
- Evidence of Ad hoc quality support and communication of risks
- Evidence of completion of assigned Quality and Technical Agreements to eliminate any overdue
- Evidence of tracking & follow up on all outstanding assigned Quality and Technical Agreements
- Evidence of completion of assigned internal and external audits
- Evidence of participating reviews of OOS and RCAs in a timely manner and timely escalations to HOQ/QP as required.
- Evidence of timely working with relevant stakeholders to achieve timely completion of all CAPAs relating to Customer audits Internal Audit audits CAPAs.
- Evidence of successfully participating in internal audits on a bi-annual basis to cover all areas of the business.
- Evidence of timely completion of Adhoc and other tasks as assigned.