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 in all correspondence.

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