Senior Quality & Technical Specialist

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JOB BACKGROUND:

The candidates will have significant experience within the Pharmaceutical Industry across a number of the following disciplines: Quality Systems, Quality Operations, QC Laboratory, Analytical or Process Validation, Manufacturing, Production or Warehouse.

Understand and describe the difference challenges associated with manufacturing various pharmaceutical dosage forms and understand the key quality attributes.

Provide Guidance and support to the growing number of contract manufacturing organisations within the Atnahs portfolio, ensuring that Quality Actions are effectively managed.

KEY RESPONSIBILITIES:

  • Review and approve process and analytical method transfers
  • Review and approve Quality and Technical Agreements to ensure key responsibilities are documented
  • Where required provide on site Quality support for product transfers or when required
  • Effectively manage the Quality aspects of several Contract Manufacturing Organisations
  • Lead timely discussion of OOS with other Technical Managers and plan appropriate timely face to face or telecom discussion with all stakeholders
  • Complete assigned internal audits
  • Support internal staff 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 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 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 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

 

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