Quality Specialist

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JOB BACKGROUND:

The candidates will provide a quality support to the Quality Systems, Operational Quality and Technical Quality teams as required.

KEY RESPONSIBILITIES:

  • 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.

KEY ACCOUNTABILITIES

  • 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.

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