QA Specialist, Change Controls & Deviations

Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!

Proclinical is seeking a QA Specialist to support the operational implementation and continuous improvement of Quality Management Systems (QMS) within a pharmaceutical environment. This role focuses on managing Change Controls, Deviations, and CAPA processes from a quality assurance perspective. If you are passionate about contributing to a patient-centric organization and thrive in a fast-paced, collaborative setting, this opportunity could be for you.

Responsibilities:

• Manage Change Controls, including gathering impact assessments, leading risk assessments, and ensuring timely approvals and closures.
• Support internal stakeholders with risk assessments aligned with ICH Q9 principles to implement mitigation measures.
• Oversee the classification and documentation of changes, ensuring traceability and compliance.
• Assist in the initiation, assessment, investigation, and lifecycle management of Deviations, CAPAs, and Change Controls.
• Ensure accurate and compliant documentation of quality events within defined timelines using electronic QMS tools.
• Collaborate with cross-functional teams to facilitate timely closure of quality events.
• Lead or assist in root cause analysis using tools like 5 Whys or Fishbone diagrams.
• Support the creation, revision, and management of QA-controlled documents, including SOPs and Work Instructions.
• Track and ensure SOP training completion for compliance.
• Prepare KPIs and Quality Metrics related to Deviation, CAPA, and Change Control processes.
• Contribute to trend analysis and participate in Quality Review or Management Review meetings.
• Assist in configuring and maintaining the Veeva Vault platform and provide user support as needed.

Key Skills and Requirements:

• Degree in Life Sciences (e.g., Pharmacy, Chemistry, Biology) or equivalent professional experience.
• Experience in a GxP-regulated pharmaceutical environment (GDP or GMP).
• Familiarity with quality system processes such as Deviation, CAPA, and Change Control.
• Knowledge of EU GDP/GMP guidelines, MHRA expectations, and EudraLex Vol 4.
• Proficiency with electronic QMS tools (e.g., Veeva, Trackwise, MasterControl).
• Strong problem-solving skills and ability to adapt to high-speed change.
• Attention to detail, documentation accuracy, and a results-driven mindset.
• Effective communication and collaboration skills.
• Ability to work independently with minimal supervision.

If you are having difficulty in applying or if you have any questions, please contactJosh Goddenat.

Apply Now:

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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.

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