Job Description

QA Specialist

Key Responsibilities:

• Compile and review batch release documentation to support Qualified Person (QP) certification of Investigational Medicinal Products (IMP) for clinical trials.
• Maintain and update the site's Manufacturing and Importation Authorisation (MIA) in compliance with regulatory requirements; manage the Site Master File.
• Generate and maintain Product Specification Files (PSF) for IMP.
• Provide QA oversight and support for IMP packaging and labeling operations.
• Support the creation and maintenance of Quality Agreements with internal and external partners.
• Provide Quality Assurance input to the Use Date Extension process for IMP.
• Deliver GMP/GDP guidance and training for Clinical Supply Operations across EMEA and Asia regions.
• Investigate non-conformances and quality incidents, ensuring timely resolution and documentation within the Quality Management System (QMS). Track deviations, investigations, and CAPAs.
• Support supplier and customer qualification activities, including documentation review and timely completion of qualification and re-qualification processes for RP review.
• Support Health Authority inspections and internal audits.
• Prepare, review, and maintain procedural documents (SOPs, policies, work instructions).
• Complete change control assessments, CAPA evaluations, and participate in CAPA close-out activities.
• Collaborate cross-functionally to ensure compliance with corporate policies, GMP, and applicable regulatory standards.
• Participate in Operational Excellence (OPEX) programs and promote continuous improvement in quality processes.

Required Qualifications & Skills:

• Bachelor’s degree in a scientific, engineering, or related discipline.
• Minimum of 3 years’ experience in the pharmaceutical or biopharmaceutical industry.
• Strong working knowledge of ICH guidelines, GMP, GDP, data integrity principles, and clinical supply chain operations.
• Ability to work independently and collaboratively across functional teams to meet project timelines in a fast-paced environment.
• Excellent communication, presentation, and critical thinking skills are essential.

The Next Step for you:  

• Should this position be of interest to you please submit your CV to Barry O’Mahony from Next Generation Recruitment using the apply button.
• Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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