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Barden are delighted to be supporting our client in their search for a QA Validation Lead. Our client is a premier provider of vaccine services, covering the entire spectrum from discovery to commercialisation.
ABOUT THE ROLE:
As a QA Validation Lead, you will play a pivotal role in ensuring the quality and compliance of validation and equipment qualification activities. This role involves overseeing computerized systems and lab equipment qualification, aligning with all relevant regulations, company policies, and contractual obligations. By reviewing and approving commissioning and qualification activities, you’ll contribute to the meticulous execution of validation lifecycle documents. Additionally, you will provide essential guidance for equipment lifecycle documentation, actively participate in investigations, review SOPs, deviations, and collaborate on customer audits and regulatory inspections.
Department Description:
In this role, you’ll report directly to QA Director, collaborating closely to achieve the quality assurance goals.
Your Responsibilities:
- Oversee validation and equipment qualification activities, ensuring compliance with regulations and obligations.
- Review and approve commissioning and qualification activities, encompassing the validation lifecycle process
- Provide guidance for creating equipment lifecycle documentation, including protocols, assessments, and technical specifications
- Participate or lead investigations related to qualification discrepancies
- Review and approve SOPs, deviations, and other key quality documents
- Participate in customer audits and regulatory inspections
- Collaborate with internal and external stakeholders to ensure effective communication
- Align with company’s quality strategy and contribute to continuous improvement
- Fulfil additional tasks as directed by the QA department management
ABOUT THE PERSON:
The ideal candidate for this position will have the following:
- Minimum of a bachelor’s degree in biology, biotechnology, or a relevant discipline
- A minimum of 6 years of QA experience in the biotech/pharmaceutical industry, with preference given to those with vaccine or biologics experience
- Strong understanding of cGMP requirements, GCPs, GLPs, GAMP, and Part 11 compliance
- Excellent knowledge of validation principles and industry best practices
- Familiarity with audit challenges and regulatory inspections
- Effective problem-solving skills and adaptability in a fast-paced environment
- Exceptional written and oral communication skills for cross-functional interaction
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.
