Senior Quality Assurance Manager OSD
Vor 2 Tagen
Gi Life Sciences is seeking a Senior Quality Assurance Manager for our partner in the Canton of Neuchätel.
About the Role:
This position is accountable for overseeing Quality Control activities at an OSD drug product manufacturing site, including method transfer and verification, analytical and microbiological testing, equipment cleaning residual testing, and environmental monitoring. The successful candidate will ensure all activities meet cGMP requirements and customer expectations.
Key Responsibilities:
- Manage project execution to ensure timely and high-quality completion of analytical activities, in compliance with Quality Management Systems (QMS) and cGMPs.
- Lead OOX results laboratory investigations and deviation investigations, perform impact assessments, and establish corrective actions and preventive measures based on root causes.
- Optimize QC processes, including procedures and daily operations, to reduce lab errors and increase efficiency.
- Oversee the daily management of the Quality Control team, ensuring effective planning, communication, team organization, control, and feedback.
- Represent QC during client visits, audits, regulatory inspections, and health authority audits.
Requirements:
- University studies in chemistry, biochemistry, biology, or pharmacy or equivalent.
- >10 years' experience in OSD QC laboratory management, CMO advantageous.
- Fluency in French and English.
- Solid knowledge of analytical technologies and laboratory workflows, such as HPLC, dissolution, Karl-Fischer analysis, etc.
- Familiarity with electronic data lifecycle management in the laboratory to ensure data reliability and integrity.
- Knowledge of method transfer and validation of drug products, material and product release, as well as stability studies of drugs under different conditions.
- Strong working knowledge to ensure quality control compliance with applicable regulations, i.e., cGMP.
- Organized and rigorous, able to provide leadership and coaching to the QC team to maintain an environment of trust and personal accountability.
- Ability to effectively communicate with the team and all levels of the organization. Work as a strong team partner in the site.
- Ability to take decisions based on scientific risk assessment, to reduce and control the risk of late-stage commercialization project operations.
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