QA Specialist - Drug Product
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.
- 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
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.