Quality Assurance Specialist - Mendrisio, Schweiz - Sintetica

Beschreibung

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 anesthesia and analgesia, while expanding to address further healthcare needs.

To strengthen our Quality Assurance team in Mendrisio (Canton Ticino), we are currently looking for a Quality Assurance Specialist mainly skilled in validation activities.

Position summary

The resource will be integrated in the Quality Assurance Team and will contribute to establish and maintain the Company's Quality System and ensure the ongoing reliability of the manufacturing process. Focusing on QA processes, he/she will be responsible for the proper qualification of the equipment and installations, and for the process validation.

Essential tasks and responsibilities

• Editing and issuance of qualification documents as well as final reports and GMP related documents (risk analysis, technical reports, etc.)
• Execution of qualification of equipment, utilities and machines, process validation and cleaning validation processes
• Analysis and evaluation of KPI and data monitoring to ensure a continuous improvement of the quality system
• Deviation and Change Control management
• Quality investigations and definition of corrective and preventive actions
• Definition of Standard Operating Procedures (SOP) and GMP-related documentation along with other relevant units/ department Managers
• Contribution to the implementation of innovative industrial Projects.
• Involvement in self-inspections and in third parties inspections
• Drawing of validation protocols, and final validation and qualification reports
• Definition of staff training plans and coordination of training and education activities.
• Cooperation with production and maintenance to define Gantt of shutdown activities and in general Gantt for qualification activities in order to have close alignment.

More specifically, the position includes the following tasks:

• Plan and coordinate validation activities in collaboration with the concerned department manager.
• Develop and maintain relationships with external validation service suppliers and planning their interventions.
• Based on the documentation, deliver Training to employees who are involved in validation activities.
• Participate to issue the Validation Master Plan and the Validation Project Plans related to the industrial projects.
• Accomplish planned validation tasks, with the support of external or internal staff.
• Assure that the installation of new machines and utilities is performed according to relevant documentation (QD, IQ, QO, etc.).

Required skills and core competences

• Bachelor/Master degree in technical scientific subjects (Chemistry, Pharmacy, Engineering or equivalent)
• 5 years' experience in the pharmaceutical field, production, or quality assurance
• Expertise in injectables anesthetics (Production) and terminally sterilized products will be considered an asset.
• Good knowledge of the pharmaceutical industry and expertise in pharmaceutical manufacturing and GMP procedures will be considered an asset
• Fluent in spoken and written Italian and English, knowledge of French will be considered an asset.
• Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude.
• Management and organizational skills, flexibility, learning agility and strategic thinking.
• Commitment to continuous improvement.
• Preference will be given to candidates of Swiss nationality and residents (Permit B - C)

We offer

Fulltime permanent employment in a young, dynamic work environment and positive culture.

Sintetica promotes Diversity and Gender Equality.