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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 contact Josh Godden at .
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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