Function Summary
The QA QC Expert is responsible for the quality oversight of Drug Substance batch testing and release, as well as QA oversight for Quality Control (QC) activities at the Incyte Bioplant facility in Yverdon-les-Bains. This includes batch disposition preparation, analytical method transfers/validation, laboratory equipment qualification, and routine testing, ensuring compliance with Incyte Quality policies, cGMP, Swiss, EU, and US FDA regulations.
Key Responsibilities
Drug Substance/Product Release
- Collect and review all records required for Drug Substance/product batch disposition and shipping.
- Chair weekly Drug Substance/product disposition meetings and maintain related KPIs.
- Review DS/DP QC data for release.
- Release materials including raw materials and QC materials/reagents (e.g., standards, controls).
- Approve sampling plans.
Quality Control Oversight
- Manage day-to-day QA oversight of the QC laboratory.
- QA lead for method transfers and validation, including approval of protocols and reports.
- QA representative for laboratory SOPs development, updates, and periodic reviews.
- QA approval of specifications and analytical methods.
- QA contact for QC deviations, OOS, and OOT as well as for Change controls.
- Review and approve stability protocols and reports.
- Approve LIMS master data changes.
- QA oversight for environmental and utilities monitoring programs, if needed.
- QA point of contact for Biologic Process Sciences SOPs and equipment commissioning/qualification.
- Support commissioning and qualification of laboratory equipment.
- Lead or contribute to risk assessments.
- Coach QC personnel on quality compliance matters.
- Support the preparation of Annual Product Reviews (QC part).
- Ensure QA oversight for all quality events related to QC activities.
- Contribute to the maintenance of Incyte’s Quality System.
- Support Health Authorities’ inspection readiness programs and act as Subject Matter Expert in area of expertise, including the support for submission/filling dossier review.
- Interpret and implement GMP, regulatory requirements, and Quality Systems regulations applicable to QC.
- Support QA team in related support functions including incoming goods and vendor assessments.
- Foster understanding and application of cGMPs by Bioplant employees.
- Perform all responsibilities in accordance with company policies, procedures, applicable regulations, and safety requirements.
- Promote a strong culture of Quality, business integrity, and ethics.
- Act within compliance and legal requirements as well as company guidelines.
Reporting Line
Delegation to: Manager Release, QA QC.
Requirements
- Bachelor’s or academic degree in a relevant field (Chemical Engineering, Bio-engineering, Bioprocessing, Pharmacy, Chemistry, Biotechnology).
- Expertise in Microbiology and/or Chemical/Biochemical.
- Minimum 5 years’ experience in a GMP environment.
- Demonstrated experience in QA for QC topics; experience in batch release preferred.
- Thorough knowledge of biotechnology processes, laboratory equipment, and cGMP/cGDP.
- Familiarity with global regulatory requirements applicable to pharmaceutical manufacturing and testing requested.
- Proficiency in quality systems and computerized systems integration.
- Experience in Health Authorities inspections requested.
- Ability to make pragmatic and compliant decisions.
- Strong interpersonal skills and ability to interact effectively across disciplines.
- Strong result orientation, flexibility, and commitment to teamwork.
- Excellent written and verbal communication skills in English and French.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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