Job Description

Established in 1921 in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide, through innovative science and excellence in development, production and marketing. Our people are the biggest asset. That is why we believe in the great place to work culture that promotes creativity, informed risk-taking, an exciting environment and a good feeling in everyday work. To strengthen our team in Couvet (NE), we are currently looking for full-time
Quality Assurance Specialist focus on Qualification/Validation
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.

• 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.