QA Specialist - Drug Product job in Reykjavík, Iceland

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Good Pharmacovigilance Practice (GVP)

Location: Iceland

This vacancy has now expired. Please see similar roles below...

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

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