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.
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.
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