QA Specialist

CK Group are recruiting for a QA Specialist, to join a leading pharmaceutical organisation, that develop and manufacture veterinary products. This role will be working on site in Dundee, on a contract basis for 3 months.

QA Specialist Role:

You'll play a vital part in ensuring the quality and safety of innovative health solutions for animals large and small on a global stage.

Key Responsibilities:

Perform activities for the batch release process to ensure all documentation is checked and available for QP release to meet the OTIF requirements.
Perform activities for Disposition of raw materials and packaging and to ensure all materials are available when required.
Perform QA activities to ensure documentation reviews and feedback are performed in a timely manner.
Deviation Management and working with internal stakeholders & external partners to resolve issues and identify effective CAPA’s in a timely manner.
Review, advise and approve effective change control actions across the Facility ensuring compliance with the necessary regulations.
Write/revise/approve and give advice on quality documentation, Raw Material specs, Finished Product Specifications, MOAs.
Identify revisions / new procedures that impact cGMP activities, as required and ensures the relevant departmental standard operating procedures (SOP’s) are complete & accurate.
Support the audit platform, for both internal & external audit and ensuring compliance to the annual self- assessment / self-audit platform as defined by the Site Quality team.
Review and check QC Documentation including analytical data check, (finished product, excipients, packaging testing results).
Review and provide feedback on Laboratory Investigation Reports and perform QA approval.
Your Background:

Educated to degree level or equivalent in a relevant scientific discipline such as Chemistry or Biology.
Experience in a QA position in a pharmaceutical company.
Good knowledge and understanding of cGMP, quality systems and quality practices associated with deviations, change control, validation including CSV, Vendor Qualification, batch record reviews and Annual Product Reviews.
Ability to work with competing priorities and achieve multiple deadlines / timeframe's.
Effective communication, negotiation and influencing skills.
Ability to work independently and employ the initiative to find solutions, prioritise and exercise discretion.
Strong attention to detail with a record of driving quality performance with a quality focussed attitude.
Apply:

It is essential all applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.

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