QA Specialist - Drug Product

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. Iceland
Reykjavík, Iceland
Posting date: 20 Jul 2020
30687

An exciting opportunity has arisen for a QA Specialist to focus specifically on Drug products. The role based in Iceland is great time to build your portfolio with a leading pharmaceutical company.

Job Responsibilities

  • Provide general QA expertise and support for drug product manufacturing
  • Provide QA support to project teams and perform review of regulatory submission dossier documentation, prior to obtaining regulatory approval.
  • Provide QA expertise during the investigations of Deviations or OOS; and QA approve these and their related CAPAs.
  • Support and approve Change Control records
  • Contribute to the preparation of inspections as per defined and agreed role.
  • Participate in CAPAs resolution of inspection findings.
  • QA review and approval of QMS documentation, e.g. master batch records, SOPs and reports (e.g. hold time studies, media fill reports).
  • Review of batch records and associated documents from drug product manufacturing department before a formal release to the next manufacturing step
  • Contribute to the development, approval and maintenance of quality policies and procedures as required
  • Participate in and provide documentation for business diligence visits.
  • Work closely with drug product manufacturing department to ensure delivery of key project objectives and timelines

Skills and Requirements

  • Minimum of BSc in pharmacy, biotechnology, biochemistry, chemistry or related fields
  • Significant QA or manufacturing experience (5-10 years) working with sterile manufacturing.
  • Thorough understanding of Quality Systems and GMP environment of pharmaceutical manufacturing
  • Excellent written and oral communication skills both in English
  • Strong collaboration skills and ability to build partnerships internally and externally
  • Critical thinking and evaluation of process problems
  • Collaborative team player


To Apply

In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-KB1

#QualityAssurance

close