Proclinical is seeking a QA Specialist to join a dedicated team. The successful candidate will be responsible for performing QA reviews of manufacturing, QC, and engineering records, as well as reviewing and approving procedures and GMP deviations. This position requires a solid understanding of quality assurance systems, methods, and procedures.

Responsibilities:

Ensure compliance with applicable cGxP regulatory requirements.Review routine manufacturing, QC, and engineering documentation, including batch manufacturing records.Assist in the completion of manufacturing-related customer complaint investigations.Author, review, and approve Standard Operating Procedures (SOPs) and other controlled documents.Identify deviations from accepted practices, evaluate impact, and determine appropriate actions.Review and approve GMP deviation investigations and CAPAs.Identify problems and generate alternatives and recommendations.Complete routine and complex projects/assignments.Perform internal audits and walkthroughs to ensure site compliance with GMP.Participate in site strategic, technical, and operational excellence projects on behalf of QA.Represent the QA function at relevant cross-functional meetings.

Key Skills and Requirements:

Experience in the pharmaceutical industry, ideally within a QA role.Working knowledge of current Good Manufacturing Practices (cGMPs) and quality systems.Familiarity with OPEX Lean tools and root cause analysis tools.Strong audit, investigation, and report writing skills.Proficiency in Microsoft Office applications.Excellent verbal, written, and interpersonal communication skills.Positive attitude and ability to work as part of a team.Resilient and able to deliver in a challenging environment.Ability to engage and manage multiple stakeholders.Curious with a strong learning agility.Operationally excellent and organized with a systematic approach to prioritization.Process-oriented to achieve business objectives.

If you are having difficulty in applying or if you have any questions, please contact Elise Stewart at e.stewart@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.