QA Specialist

Walker Cole International is supporting a leading biopharmaceutical organisation in the appointment of a QA Specialist to support quality operations and technology transfer activities across a GMP-regulated biologics manufacturing environment.

This position will focus on providing Quality Assurance support for commercial manufacturing, product lifecycle management and biologics technology transfer activities, ensuring compliance with GMP requirements and regulatory expectations. The successful candidate will work closely with Manufacturing, Quality Control, Validation, Supply Chain and Technical Operations teams to support ongoing site projects and operational quality initiatives.

Key responsibilities:

• Provide Quality Assurance support across biologics manufacturing and technology transfer activities, with a focus on upstream and downstream processing operations.
• Support quality oversight of GMP manufacturing operations, ensuring compliance with internal procedures and regulatory requirements.
• Review and approve batch manufacturing records and associated GMP documentation.
• Manage and support deviation investigations, CAPAs, change controls and quality risk assessments.
• Provide QA input into new product introduction (NPI), process transfers and product lifecycle management activities.
• Collaborate with Manufacturing, QC, Validation and Supply Chain teams to ensure compliant project execution and operational readiness.
• Support analytical laboratory, packaging and manufacturing quality activities where required.
• Assist with internal audits, regulatory inspections and supplier quality activities.
• Ensure quality systems remain compliant with FDA, EMA and other applicable regulatory standards.
• Support continuous improvement initiatives relating to quality systems, compliance and operational excellence.

Required experience and skills:

• Minimum 6–8 years of Quality Assurance experience within pharmaceutical, biotechnology or other highly regulated manufacturing environments.
• Strong experience supporting biologics manufacturing operations, with particular focus on technology transfer, upstream and downstream processing activities.
• Proven Quality Assurance experience across commercial manufacturing and product lifecycle management.
• Experience supporting one or more of the following functions: New Product Introduction (NPI), Quality Control, Analytical Laboratories, Manufacturing Operations, Packaging, Validation or Supply Chain Quality.
• Strong understanding and practical application of cGMP, GDP, quality management systems and regulatory compliance requirements.
• Experience with batch record review, deviation management, CAPA investigations, change control and quality risk management processes.
• Experience supporting internal audits, regulatory inspections and compliance activities.
• Knowledge of FDA, EMA and international GMP regulations.
• Excellent communication and stakeholder management skills within cross-functional environments.
• Ability to work independently while managing multiple quality priorities within a fast-paced manufacturing environment.

Working pattern:
3–4 days onsite, full-time hours

Employment type:
12-Month Contract

Location:
Dublin, Ireland

Keywords:
QA Specialist | Quality Assurance | GMP | Biologics | Technology Transfer | Tech Transfer | Upstream Processing | Downstream Processing | Batch Record Review | Deviations | CAPA | Change Control | Quality Systems | NPI | Manufacturing Quality | QC | Validation | GDP | FDA | EMA | Pharmaceutical | Biotechnology | Compliance

ID: 107245