Quality Assurance Specialist (focus on Computer System Validation) - Mendrisio Site (Ticino)

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 SummaryThis 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 computer system validation and quality compliance, 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 ResponsibilitiesKnowledge of Computerized System Validation methodologies and proven experience in the management/drafting and implementation of the Computer System Validation Plan. Specifically:

Definition/formalization of the computerized system validation strategy in compliance with guidelines and Data Integrity principles. Execution of computerized system validation activities, including setting priorities, planning and coordinating the issuance/revision of deliverables, and executing validation protocols (IQ/OQ/PQ), with the support—when necessary—of other departments and/or service providers.

Management of deviations, Change Control and complaint processesHandling of investigations and definition of corrective and preventive actions (CAPA) in collaboration with relevant site functionsManagement of Standard Operating Procedures (SOPs) and documentation related to cGxP, in coordination with other units, departments, and responsible managersActive participation in self-inspectionsAnalysis and evaluation of KPIs, and monitoring of data to ensure continuous improvement of the quality systemDrafting 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 customersContribution to the implementation of industrial projects in line with the timelines defined by the company strategyRequired Skills And Core CompetenciesDegree in a technical or scientific field (Chemistry, Pharmacy, Engineering, or equivalent)Strong knowledge of the pharmaceutical industry:

Annex 1, Annex 11, GAMP5 and cGxP/CFR21p11 regulationsAt least 3 years of experience in the pharmaceutical industryExperience in the production of injectable and terminally sterilized products (considered a plus)Excellent command of Italian and good knowledge of English; knowledge of French is considered an advantageExcellent communication skills, proactivity, autonomy, accuracy, and a team-oriented attitudeStrong organizational and management skills, flexibility, ability to learn quickly, and commitment to continuous improvementWe offerFull-time permanent employment in a young, dynamic work environment and positive culture. Sintetica promotes Diversity and Gender Equality.