Sintetica Couvet

Quality Assurance Manager - Couvet site (Neuchâtel)

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 for the benefit of 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 Couvet, we are currently looking for the Quality Assurance Manager

 

Position summary

Within the Corporate Compliance & Innovative Projects Unit, reporting hierarchically to the site Director and functionally to the QA Corporate Director, the Quality Assurance Manager is responsible for the Company's Quality System ensuring the ongoing reliability of the entire manufacturing process as well as the quality of the final product on site. The QA Manager ensures the proper application of the GMP, the correct execution of all certifications with the accredited bodies, and the overall alignment to the Corporate Quality procedures.

 

Key tasks and responsibilities

The QA Manager (he/she) will be responsible for

  •  Measuring and improving the QA performance according to the relevant KPIs
  •  Managing and overseeing all QA activities including validations, qualifications, Execution of batch record review, validation, qualification of equipment utilities and machines, Deviation, complaints and Change Control management, Supplier qualification for finished and semi-finished products, materials, raw materials and their periodic requalification …etc.   The incumbent will be responsible and focused on
  •  Leading and developing the existing QA Team of 10 resources
  •  Implementing the policy of Quality Assurance according to Corporate QA guidelines
  •  Defining SOPs (Standard Operating Procedures) and GMP-related documentation along with other involved units/ department Managers and secure compliance with GMP
  •  Analysis and evaluation of monitoring data and key performances indexes in order to insure a continuous improvement of the quality system
  •  Quality investigations and definition of corrective and preventive actions
  •  Issuance of Master Batch Records, validation and qualification protocols, reports and GMP related documents (risk analysis, technical reports, etc.)
  • Managing self-inspection and third parties' inspections
  • Assuring that all QA Activities are performed in time and in accordance to finished product release processes 
  • Carrying on controls and audits of the internal Quality system

 

Required qualification and experience  

  •  Master/Doctor's degree in Pharmacy, in Chemistry, Engineering, or related technical science disciplines
  •  Over 10 – 15 years' experience - with successful team management - within the pharmaceutical industry, in QA or Production, preferably gained in small-medium Pharmaceuticals with marketing authorization (GMP certificated) released by local Health authorities (FDA, Swissmedic,…)
  •  Expertise in injectable aseptically filled products (manufacturing) and terminally sterilized products will be a must, together with excellent knowledge and expertise in pharmaceutical GMP procedures
  •  Digital thinker, the QAM will contribute to and promote Sintetica' innovation and digitalization process

 

Skills

  •  Excellent knowledge of French and English, verbal and written. Italian would be an asset
  •  Strong management and leadership skills to lead and motivate the team
  •  Organizational capabilities
  •  Excellent relational and communication skills, keen to collaborate proactively
  •  Pragmatic and with a problem-solving attitude
  •  Strong commitment to continuous improvement

We look for someone with Swiss work permit or willing to relocate.

 

We offer

Fulltime permanent employment in a young, dynamic working environment and positive culture. Couvet is located in the beautiful nature of the Val-de-Travers, Canton of Neuchatel, Switzerland.

Sintetica promotes Diversity and Gender Equality.

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