QA Specialist

CK Group are recruiting for a QA Specialist to join a leading pharmaceutical organisation, that develop and manufacture veterinary products. This role is permanent and based in Dundee.

The Role:

An exciting opportunity has opened for a

QA Specialist

at a manufacturing facility. The QA Specialist will be responsible for ensuring the compliance of materials, products, and components, as well as services related to manufacturing, by establishing and maintaining regulatory and cGxP frameworks.

• Your Background:
• Oversee and approve the handling, release, and documentation of raw materials, packaging, and finished products, ensuring all ERP and compliance requirements are met.
• Participate in managing deviations and implementing corrective and preventive actions (CAPAs) to maintain product quality.
• Review, provide guidance, and authorize change control initiatives to ensure regulatory compliance across the facility.
• Support investigations into customer complaints and provide quality-focused recommendations.
• Monitor and ensure adherence to the site’s ongoing product stability testing programme (FUST).
• Draft, update, review, and approve GMP documentation while offering expert advice on quality practices.
• Assist with internal and external audits, maintaining compliance with the site’s self-assessment and self-audit schedules.

• Demonstrated Quality Assurance experience of 2-3 years, in a regulated Industry, preferably Pharmaceuticals
• Good knowledge and understanding of cGMP, quality systems and quality practices

  associated with production, analytical testing and documentation

• Ability to work with competing priorities and achieve multiple deadlines / timeframes
• Effective communication, negotiation and influencing skills
• Ability to work independently and employ the initiative to find solutions, prioritise and

  exercise discretion

• Has a proactive and flexible approach to work
• Strong attention to detail with a record of driving quality performance with a quality

  focussed attitude

It is essential all applicants hold entitlement to work in the UK. Please quote job reference 161 353 in all correspondence.

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