Preferred candidates must be an approved Lead Auditor and must have current experience of EU GMDP audits of some of the following:
Third-party Manufacturer(s), Testing Laboratory, Warehouse and Transportation
- External Audits
- Complete QTAs
- Complete Stability Report Reviews
- Complete internal and external “For Cause Audits” & Leading Internal Audits
- Complete elemental impurities risk & excipient risk assessment
- Ad hoc quality support for setting up new CMO
- External Audit of all product formulations (Solid dose, APIs, Sterile, Liquid formulations).
- Review Analytical method transfers
- Quality and technical agreements to be completed in order of risk and engage with stakeholders to complete new / updates in a timely manner.
- Take a lead in agreeing with stakeholders & tracking to completion of all CAPAs relating to Customer audit of Waymade & Internal Audit audits CAPAs.
- Lead timely discussion of OOS with other Technical Managers and plan appropriate timely face to face or telecon discussion with all stakeholders.
- Complete assigned internal and external audits
- Lead Auditor for Internal Audits on a Bi-annually basis
- Support internal staff auditor development.
- Evidence for completion of assigned elemental impurities risk & excipient risk assessment
- Evidence of Ad hoc quality support for setting up new CMO
- Evidence of completion of assigned Quality and Technical Agreements to eliminate any overdues.
- Evidence of tracking & follow up on all outstanding assigned Quality and Technical Agreements.
- Evidence of completion of assigned internal and external audits.
- Evidence of Leading 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 audit of Internal Audit audits CAPAs.
- Evidence of successfully leading of 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.
- Completion of assigned elemental impurities risk & excipient risk assessment & Nitrosamines risk assessment does not hold up batch release.