Requirements: English
Company: Sintetica
Region: Mendrisio , Ticino
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Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica''s mission is to improve therapies by enhancing product formulations and usability for clinicians and patients.
We collaborate with clinical experts to understand unmet needs and push the limits of science and technology to make therapies safer and easier to perform. We supply millions of doses annually across various therapeutic classes, including anaesthesia and analgesia, while expanding our healthcare offerings.
To strengthen our Quality Assurance team in Mendrisio (Canton Ticino), we are seeking a Quality Assurance Specialist reporting directly to the Quality Assurance Manager.
Position Summary
This role is part of the Quality Assurance department, crucial for maintaining high-quality standards of processes and products. The ideal candidate is curious, detail-oriented, passionate about compliance and quality, eager to learn through cross-functional collaboration, and motivated to contribute to continuous improvement at the manufacturing site. It offers a meaningful professional challenge in a dynamic, quality-driven environment.
Main Tasks and Responsibilities
- Manage deviations and Change Control processes
- Handle investigations and define corrective and preventive actions (CAPA) in collaboration with relevant site functions
- Manage Standard Operating Procedures (SOPs) and documentation related to cGxP, coordinating with other units and managers
- Define personnel training plans and coordinate training activities
- Participate in self-inspections
- Manage suppliers in accordance with company policy (qualification, audits, complaints, change notifications)
- Analyze KPIs and monitor data for continuous quality system improvement
- Draft and issue documentation supporting the site quality system (risk assessments, technical reports, user requirements, etc.)
- Support and participate in inspections by regulatory authorities or customers
- Contribute to industrial project implementation aligned with company timelines
Required Skills and Core Competencies
- Degree in a technical or scientific field (Chemistry, Pharmacy, Engineering, or equivalent)
- Minimum of 5 years of experience in the pharmaceutical industry
- Experience in producing injectable and terminally sterilized products is a plus
- Strong knowledge of pharmaceutical industry regulations, including Annex 1 and cGxP
- Fluent in Italian and proficient in English; knowledge of French is advantageous
- Excellent communication, proactive, autonomous, accurate, and team-oriented
- Strong organizational skills, flexibility, quick learner, committed to continuous improvement
We Offer
Full-time permanent employment in a young, dynamic environment with a positive culture. Sintetica promotes diversity and gender equality.
Additional Information
- Seniority level: Entry level
- Employment type: Full-time
- Job function: Quality Assurance
- Industry: Pharmaceutical Manufacturing
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