Overview
Quality Assurance Specialist – Mendrisio Site (Ticino) Jobs in Mendrisio, Ticino, Switzerland at Sintetica
Title: Quality Assurance Specialist – Mendrisio Site (Ticino)
Company: Sintetica
Location: Mendrisio, Ticino, Switzerland
Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica’s mission is to continuously strive to improve therapies by enhancing its products’ formulations and usability to benefit clinicians and patients.
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year, we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.
To strengthen our Quality Assurance team in Mendrisio (Canton Ticino), we are looking for a Quality Assurance Specialist to report directly to the Quality Assurance Manager.
Position Summary
This position is part of the Quality Assurance department, a key function in ensuring the high-quality standards of the company’s processes and products. The ideal candidate is a curious and detail-oriented professional, passionate about compliance and quality, eager to expand their knowledge through cross-functional collaboration, and motivated to actively contribute to the continuous improvement of the manufacturing site. This role represents a valuable professional challenge for individuals looking to make a meaningful impact in a dynamic and quality-driven environment.
Main Tasks And Responsibilities
Management of deviations and Change Control processes
Handling of investigations and definition of corrective and preventive actions (CAPA) in collaboration with relevant site functions
Management of Standard Operating Procedures (SOPs) and documentation related to cGxP, in coordination with other units, departments, and responsible managers
Definition of personnel training plans and coordination of related training activities
Active participation in self-inspections
Supplier management in compliance with company policy (qualification, on-site audits, complaints, change notifications)
Analysis and evaluation of KPIs, and monitoring of data to ensure continuous improvement of the quality system
Drafting and issuing of documentation supporting the site quality system (including but not limited to risk assessments, technical reports, user requirements, etc.)
Support and participation in inspections conducted by regulatory authorities or customers
Contribution to the implementation of industrial projects in line with the timelines defined by the company strategy
Required Skills And Core Competencies
Degree in a technical or scientific field (Chemistry, Pharmacy, Engineering, or equivalent)
At least 5 years of experience in the pharmaceutical industry
Experience in the production of injectable and terminally sterilized products (considered a plus)
Strong knowledge of the pharmaceutical industry, Annex 1, and cGxP regulations
Excellent command of Italian and good knowledge of English; knowledge of French is considered an advantage
Excellent communication skills, proactivity, autonomy, accuracy, and a team-oriented attitude
Strong organizational and management skills, flexibility, ability to learn quickly, and commitment to continuous improvement
We offer
Full-time permanent employment in a young, dynamic work environment and positive culture.
Sintetica promotes Diversity and Gender Equality.
