QA Senior Specialist - Validation

Dundalk
1 month ago
Applications closed

Related Jobs

View all jobs

Sterility Assurance Manager (12 Month Fixed Term Contract)

Outside IR35 STEM Contractors - Oxford/Cambridge/Midlands/Central England

Director, Medical Evaluation & Case Processing Oversight

Team Lead (MSAT Biology)

Radiopharmaceutical QP

QA – CSQ/CQV Specialist

We are actively seeking to recruit a CSQ/CQV to become a key member of the Quality Team of a leading Pharmaceutical Multinational.

The successful candidate will provide QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the site supporting the transition from project phase through to sustaining phase with respect to validation activities

Responsibilities

  • Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.

  • Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria.

  • Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements.

  • Review SOPs relating to qualification/validation activities.

  • Provision of support in Regulatory inspections and Client audits.

  • Provision of QA Validations expertise to maintain validation status of the facility.

  • Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.

  • Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables.

  • Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training.

    Education background/ Experience

  • B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).

  • Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment.

  • Thorough understanding of the validation requirements associated with a cGMP manufacturing facility

  • Strong technical aptitude is required.

  • Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.

  • Knowledge of trouble shooting and problem-solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Jobs

CSL Behring Jobs UK: Careers, Salaries, Locations & How to Get Hired

CSL Behring is one of the world’s leading biopharmaceutical companies specialising in plasma-derived therapies, recombinant proteins, gene therapy, vaccines, and rare disease treatments. If you’re a UK job seeker looking for a career with real purpose, strong scientific standards, and long-term progression, CSL Behring roles can be an excellent fit, especially if you have experience in biotech, pharma manufacturing, quality, engineering, supply chain, clinical operations, regulatory, pharmacovigilance, or commercial. This guide is written for UK candidates who want to understand what CSL Behring jobs typically involve, which roles to target, where opportunities may be based, what skills recruiters look for, and how to tailor your application to stand out.

Careers

How Many Biotechnology Tools Do You Need to Know to Get a Biotech Job?

If you are trying to break into biotechnology or progress your career, it can feel like the list of tools you are expected to know is endless. One job advert asks for PCR, another mentions cell culture, another lists bioinformatics pipelines, automation platforms or GMP systems. LinkedIn makes it worse, with people sharing long skills lists that make you wonder if you are already behind. Here is the reality most biotech employers will not say out loud: they are not hiring you because you know every tool. They are hiring you because you understand biological systems, can work accurately and safely, follow protocols, interpret results and contribute reliably to a team. Tools matter, but only when they support those outcomes. So how many biotechnology tools do you actually need to know to get a job? The answer depends on the role you are targeting, but for most job seekers it is far fewer than you think. This article breaks down what employers really expect, which tools are essential, which are role-specific, and how to focus your learning so you look employable rather than overwhelmed.

Jobs

What Hiring Managers Look for First in Biotechnology Job Applications (UK Guide)

Hiring managers in biotechnology do not start by reading your CV word for word. They scan for credibility, relevance and risk. In a regulated, evidence-driven sector like biotech, the first question is simple: is this person safe, competent and genuinely capable of contributing in this environment? Whether you are applying for roles in research, manufacturing, quality, regulatory, clinical, bioinformatics or commercial biotech, the strongest applications make the right signals obvious in the first 10–20 seconds. This in-depth guide explains exactly what hiring managers in UK biotechnology look for first, how they assess CVs, cover letters and portfolios, and why capable candidates are often rejected. Use it as a practical checklist before you apply.

🍪 We use cookies to enhance your browsing experience on our website. By continuing to use this site, you consent to the use of cookies as described in our Cookie Policy. You can review our Cookie Policy for more information.