Commercial Manufacturing QA Specialist
vor 3 Wochen
The Commercial Manufacturing QA Specialist will contribute to and support commercial QA operations related activities for both Biologics and Small Molecules. This role will be responsible for ensuring the quality of commercial manufacturing processes and products.
Key Responsibilities- Collect and prepare batch documentation, support batch disposition for Commercial Batches, and proceed with batch disposition for assigned products from low-risk rated vendors.
- Review master (MBR) and executed batch records (EBR) for consistency with the regulatory dossier and between Master and Executed batch records.
- Support stability studies management, review and approve CMO reports, and save the documents in Veeva. Use of LIMS for the management of stability studies data.
- Consult with SME and QA colleagues in case of abnormal trend or data.
- Support CMO management with collection and compilation of metrics and review the collected data with the assigned QA.
- Support good practice implementation of the electronic Quality Systems and on-time completion of deviations, change controls, and CAPAs for the commercial manufacturing activities.
- Ensure data integrity and data consistency within the scope of the function.
- Prepare the set of documents required for the GMP applications, obtain the most recent version from CMO when necessary, review the documentation with the GDP QA team for ensuring accuracy and completeness.
- Assure the follow-up of change notification to the Incyte Partners for the changes related to commercial products.
- When relevant, issue and process Deviation, support investigation, and propose CAPA.
- Contribute to the continuous improvement of the Commercial QA operations and beyond.
- Organize the annual GMP and GDP refresher training for Morges and Wilmington for the management of the PO with the trainer and for the logistic of the classroom/virtual training sessions, assure synchronization with Yverdon.
- Assure logistic of the backroom during GMP/GDP inspections and audits hosted by IBI.
- Perform all responsibilities in accordance with company policies, procedures, applicable regulations, and safety requirements.
- Stay current with the applicable regulations and promote Quality across the Incyte organization.
- Bachelor or Master degree in Life Sciences, medical technologies, or engineering.
- Minimum of 5 years work experience in the pharmaceutical industry, with at least 1 year in a QA department.
- Good understanding of GMP requirements.
- Good interpersonal skills.
- Strong work ethic and compliance.
- Good verbal and written communication skills.
- Fluent English level written and spoken (the company language).
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Commercial Manufacturing QA Specialist
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Morges, Waadt, Schweiz Incyte VollzeitJob SummaryThe Commercial Manufacturing QA Specialist will contribute to and support commercial QA operations related activities for both Biologics and Small Molecules. This role will be responsible for collecting and preparing batch documentation, supporting batch disposition for Commercial Batches, and proceeding with batch disposition for assigned...
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