Quality & Technical Manager – Auditor

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JOB BACKGROUND:

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

KEY RESPONSIBILITIES:

  • 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

KEY ACCOUNTABILITIES

  • 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.

 

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