Quality Assurance Specialist - Mendrisio Site (Ticino)

Mendrisio , Ticino, Switzerland

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: TN Switzerland
Region: Mendrisio , Ticino

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Client:

Sintetica

Location:

Mendrisio, Switzerland

Job Category:

Other

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Job Reference:

2c8afaf5e6c5

Job Views:

3

Posted:

12.05.2025

Expiry Date:

26.06.2025

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Job Description:

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 companys 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.

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