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 QA Project & Process Validation Responsible. Reporting directly to the QA Manager, this role ensures the compliance, robustness, and continuous improvement of production processes through validation, change management and strategic projects. It is a key role in guaranteeing product quality and patient safety.Main Tasks and Responsibilities
Issuing and updating process validation plans in accordance with the Validation Master Plan.
Drafting process validation protocols providing rationale, guidelines, operating procedures, and registration forms.
Issuing, reviewing, and approving final reports summarizing the outcome of process validation activities.
Assessing the results of process validation studies, together with the Quality Assurance Manager, the Qualified Person, and the Heads of Production and Quality Control.
Supervising, reviewing, and approving, in agreement with the Quality Assurance Manager, process validation protocols produced by third parties.
Analyzing and periodically evaluating monitoring data and changes to identify potential improvements and/or issues and propose corrective actions.
Participating in the management of audits and inspections conducted by third parties, supporting the Quality Assurance Manager.
Coordinating interdepartmental activities for the planning of process validation, ensuring compliance with validation plans and production process requirements.
Coordinating, reviewing, and approving changes related to products and manufacturing processes, as well as the resulting activities.
Coordinating, reviewing, and approving company strategic projects and the activities arising from them.
Training personnel involved in process validation activities based on protocols and operating procedures.
Updating the company health risk analysis and contamination control strategy in collaboration with the Quality Assurance team.
Supporting the Quality Assurance Manager in drafting CAPA plans (when necessary).
Drafting and reviewing quality agreements with clients and ensuring their maintenance.
Reviewing, issuing, and maintaining technical specifications in collaboration with the Quality Assurance team.
Working with department managers in defining SOPs and documents required to maintain GMP compliance.
Ensuring proper maintenance of the technical documentation archive, including both current and obsolete records.
Required Skills and Core Competencies
Degree 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 regulations.
At least 5 years of experience in the pharmaceutical industry.
Experience 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 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.
Preference will be given to candidates of Swiss nationality and residents (Permit B -C)We offerFull-time permanent employment in a young, dynamic work environment and positive culture.Sintetica promotes Diversity and Gender Equality.
