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Quality Assurance Complaints Specialist (contract) - Wrexham

Quality Assurance Complaints Specialist (contract) - Wrexham

Job Title: Quality Assurance Complaints Specialist (contract) - Wrexham
Contract Type: Contract
Location: Wrexham, Wales
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: QACS1_1500801092
Contact Name: Nathan Wilson
Contact Email: n.wilson@sciproglobal.com
Job Published: July 23, 2017 10:11

Job Description

The successful applicant will have specialist knowledge of EU/US cGMP requirements pertaining to complaints reporting and investigation for medicinal products. In addition they will have sound scientific and technical knowledge in relationship with the manufacture of sterile biological drug products and the linkage to customer complaints.

Main Duties & Responsibilities

The Quality Assurance Complaints Specialist will lead and manage the Complaints process of the Wrexham site to assure that all complaints reported and requests for supporting batch investigations (adverse events and clinical trials) are investigated to the required level and appropriate action taken within the agreed business lead times.

Detailed responsibilities include:

  • Represent the site as the Subject Matter Expert (SME) for site complaints process
  • Initiate incoming partner complaint investigations using the current QMS software
  • Assess complaints for impact on patient safety and where identified, escalate in accordance with local procedures
  • Manage the return and processing of complaint samples requiring further investigation (e.g. laboratory testing)
  • Drive complaints investigations through to completion with agreed business lead times and critically review and approve all investigation conclusions
  • Report all investigation findings to the affiliate or partner
  • Provide general technical support for Medical Information queries and other queries relating to e.g. temperature excursions
  • Provide general technical support to address potential counterfeit queries
  • Ensure staff have adequate complaints training to execute their roles in an efficient and effective manner that is compliant with cGMP expectations
  • Actively trend complaints and escalate adverse signals that have the potential to impact patient safety and / or company reputation
  • Provide complaints data to support local and global metrics, affiliate requirements/reports and periodic reports (e.g. Annual Product Quality Report)
  • Generate monthly complaint reports to identify and evaluate any trend signals observed
  • Use complaints data generated to drive continuous improvements to optimise processes and performance
  • Actively trend complaints and escalate adverse signals that have the potential to impact patient safety and / or company reputation
  • Serve as primary point of contact for complaints initiated by e.g. affiliate offices, GPS (Global Patient Safety), anti-counterfeiting group and regulatory bodies

Experience & Qualifications:

Ideal:

  • 5+ years pharmaceutical experience preferably in sterile manufacturing including previous experience with pharmaceutical drug product complaints.
  • Specialist knowledge of GMP and Quality Assurance in the Biopharmaceutical Industry.
  • Knowledge in the clinical application of drug products.
  • BSc in a science discipline (biology, chemistry, pharmacy)

Minimum:

  • 2+ years pharmaceutical experience preferably in sterile manufacturing.
  • Sound knowledge of GMP and Quality Assurance in the Biopharmaceutical Industry
  • Diploma in a science discipline.