Associate Principal QA Specialist (CQV)

We are recruiting an Associate Principal QA Specialist (CQV) to join a leading Pharmaceutical organisation in Berkshire on an initial 6 month contract. We are seeking a dedicated professional to support GMP operations by managing quality assurance activities across validation and technical services functions. Based in a central hub, this role offers a chance to impact site performance and ensure regulatory compliance in a multi-product GMP setting. This pivotal position involves collaborating closely with various departments to uphold quality standards, manage compliance issues, and promote continuous improvement initiatives, helping shape a robust and compliant quality environment across the facility.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Associate Principal QA Specialist (CQV) will be varied however the key duties and responsibilities are as follows:

• Provide shoulder-to-shoulder review, approval, and support for the management of quality records such as Deviations, CAPA, Change Controls, and Investigations to uphold GMP standards.
• Oversee daily quality assurance activities within Validation and Technical Services areas, ensuring alignment with corporate requirements, standards, and regulatory guidelines including USFDA and European regulations.
• Utilize GMP knowledge to manage and escalate major and critical compliance issues via the site’s QMS processes.
• Actively identify, suggest, and contribute to continuous improvement initiatives to enhance quality systems and performance.
• As the QA SME, support departmental Quality Councils and project meetings, offering technical guidance and strategic input.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Associate Principal QA Specialist (CQV) we are looking to identify the following on your profile and past history:

• A Degree or higher level in a scientific discipline (e.g., Pharmaceutical Chemistry, Quality Assurance, Quality Management).
• Proven experience spanning 5–10 years in a QA role within a GMP biotech or pharmaceutical environment, demonstrating comprehensive knowledge of validation and GMP compliance.
• Familiarity with database management, risk-based decision making, and PQS processes, along with strong communication and interpersonal skills.
• Excellent problem-solving, organizational, and decision-making abilities, with a commitment to quality and continuous improvement.

Key Words: QA / QC / GMP / Validation / Technical Services / CQV / Regulatory Compliance / Continuous Improvement / Quality Systems / Biotech / Pharmaceutical / CAPA / Deviations / Change Controls / Investigations / Audit Readiness / PQS / Risk Based Decision Making / Pharmaceutical / Biotechnology / #LI-DNI

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".