Are you an expert in Quality Assurance and looking for a new challenge? Ready to play a key role in maintaining top-tier quality standards?

Proclinical is seeking a Quality Assurance Expert to provide compliance and quality oversight throughout the manufacturing and release process of bulk drug substances (BDS). You will play a key role in ensuring adherence to Good Manufacturing Practices (GMP), regulatory requirements, and continuous improvement initiatives. This position also involves participation in audits, inspections, and cross-functional collaboration to maintain high-quality standards.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Inspect and release raw materials and external bulk drug substances.
• Maintain and update release planning and associated KPIs.
• Oversee archiving activities as required.
• Prepare, evaluate, and approve controlled documents such as SOPs, forms, and specifications.
• Ensure timely review and implementation of documentation for accuracy and compliance.
• Lead or review deviations related to production and laboratory events, including investigations, impact assessments, and corrective/preventive actions (CAPAs).
• Manage deviation and CAPA documentation to ensure timely resolution.
• Evaluate and oversee internal and external change requests, ensuring compliance with GMP and regulatory requirements.
• Provide quality oversight and guidance to production teams during routine activities, fostering adherence to cGMP principles.
• Participate in operational decisions, including on-call support, and report potential issues with appropriate corrective actions.
• Collaborate with production, maintenance, engineering, and QC teams to define and implement process improvements.
• Participate in or lead cross-departmental meetings as needed.
• Support and promote adherence to Environmental, Health, and Safety (EHS) guidelines.

Key Skills and Requirements:

• Strong understanding of GMP principles and regulatory requirements.
• Experience in quality assurance within a pharmaceutical or biopharmaceutical manufacturing environment.
• Proficiency in managing deviations, CAPAs, and change controls.
• Ability to prepare, review, and approve technical documentation.
• Strong problem-solving skills and familiarity with investigation techniques.
• Effective communication and collaboration skills to work across departments.
• Commitment to continuous improvement and quality excellence.
• Awareness of EHS guidelines and ability to promote a safe working environment.
  

If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.

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.

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.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy .