Proclinical is partnering with a with a leading biotechnology company that specialises in RNAi therapeutics to advertise a vacancy for a Person in Plant QA position. The organisation uses this innovative form of therapy to treat rare genetic, cardio metabolic, acute hepatic infectious, central nervous system (CNS) and ocular diseases. The Office Coordinator will join this company in their office in the Netherlands. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
The Person in Plant QA will provide on-site Quality Operations and compliance management for a drug substance contract manufacturing organisation. They will manage manufacturing and disposition activities, as well as deviations, CAPA, and change controls. They will also ensure the CMO meets client and health authority expectations regarding the cGMP manufacturing. Finally, the Person in Plant QA will contribute to the team based collaborative environment promoting commitment to continuous improvement and achievement of goals.
Job Responsibilities:
- Performing pre-campaign readiness assessments to confirm the completion of requirements prior to manufacturing.
- Providing oversight of the CMOs quality management system (QMS) to confirm adherence to the quality technical agreements.
- Providing effective oversight of manufacturing operations at the CMOs, including on the floor support (at the drug substance CMO); actively observing manufacturing operations for drug substance on a routine basis to ensure compliance to cGMPs.
- Reviewing and approving CMO batch records, validation reports, test data packages, deviations, and changing controls.
- Evaluating and investigating manufacturing and lab deviations; providing direction and recommendations as to future course of actions.
- Interfacing with CMO's QA regarding any potential compliance gaps, significant/major deviation resolution and regulatory inspections.
- Maintaining a risk-based ranking of outstanding compliance gaps and remediations tasks.
- Actively supporting the Material Review Board (MRB) and other forums for major investigations involving third party manufactured or tested products; preparing and presenting the information to senior management in support of the process.
- Managing required disposition activities needed for the release of raw materials, drug substances, drug products, and finished goods.
- Developing, negotiating, and maintaining the quality technical agreements per the established procedures to support manufacturing and testing.
- Working with CMOs to evaluate inspection readiness and ensuring that appropriate corrective actions are taken to support our client expectations and successful inspection outcomes.
- Representing client Quality during any regulatory inspections of the CMOs, providing strategic and tactical guidance as needed.
- Preparing health authority audit observation responses; participating in external audits of CMOs, ensuring compliance with all appropriate and regulatory agency cGMP regulations and policy.
- Developing and supporting authoring of the annual product quality review data summaries and sections in conjunction with the CMOs.
- Implementing and monitoring vendor management key performance indicators at CMOs.
- Reporting on performances at CMOs for overall site metrics, key issues to be presented at the relevant quality review meeting.
Skills and Requirements:
- At least 8 years of experience in pharmaceutical/biopharmaceutical drug substance operations, preferably with roles in both Manufacturing and Quality.
- Experience with batch record review and release.
- Strong experience with leading and managing quality investigations.
- Knowledge of Risk Management tools.
- Strong working knowledge of cGMP requirements as applicable to drug substance.
- Experience in managing CMOs and driving process improvements.
- Strong auditing experience.
- Capable of travelling approximately 50% of the time.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Gilles Maricaux at +44 203 854 0104 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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