Join to apply for the Quality Assurance Specialist - Couvet Site (Neuchâtel) role at Sintetica
Join to apply for the Quality Assurance Specialist - Couvet Site (Neuchâtel) role at Sintetica
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The position supports our Quality Assurance Manager by establishing and maintaining the company’s entire operational & quality system.
Tasks And Responsibilities
Monitor data and key performances indicators to ensure continuous improvement
Prepare, evaluate and approve controlled documents and GMP-related documentation in collaboration with other department managers
Actively participate in the preparation and management of regulatory inspections and customer audits. Act as a reference or support person when responding to observations. Contribute to the follow-up of post-inspection commitments
Conduct internal GMP audits and participate in regulatory inspections
Lead and review deviation investigations, root cause analysis, impact assessments, and corrective/preventive actions
Contribute to the complaint’s investigation in collaboration with involved managers and follow-up with the customers
Define and implement the strategy for equipment qualification and validation of manufacturing, cleaning and sterilization processes and analytical methods.
Evaluate and approve change controls, ensuring implementation and compliance
Participate in the Supplier qualification and their periodic requalification, if needed
Issuance of Master Batch Records, batch record review and release activities
Provide training on GMP, GDP and quality related topics.
Required Skills And Core Competences
Bachelor/Master degree in related technical science (pharmacy, chemistry or equivalent)
5-7 years’ experience in the pharmaceutical field, QA & production. Experience gained preferably in small-medium pharmaceuticals with marketing authorization released by the local health authorities
Knowledge of the pharmaceutical industry and expertise in injectables production both aseptic and terminally sterilized processes with strong knowledge of aseptic behavior and ability to ensure compliance with aseptic techniques in classified areas
Practical understanding and application of a Contamination Control Strategy in sterile manufacturing
Solid expertise in Annex 1 (EU GMP) requirements, including interventions in classified areas and contamination risk control
French and English fluent
Good experience in the use of MS software
Strong relational, communication, adaptability, proactive approach, pragmatic and problem-solving skills
360° commitment to develop expertise in activities requiring high flexibility
Able to work independently and as part of a team to complete assigned tasks within established deadlines.
Seniority level Seniority level Mid-Senior level
Employment type Employment type Full-time
Job function Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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