Requirements: English
Company: Aret & Cocchi Technology
Region: Mendrisio , 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 an Equipment & Machine Qualification Responsible to report directly to the Quality Assurance Manager.
Position summary
Sintetica is looking for a proactive and detail-oriented professional to join its Quality Assurance Team.
In this role, the selected candidate will play a key part in establishing and maintaining the Companys Quality System, ensuring the ongoing reliability of manufacturing processes. He/she will assume full ownership of QA-related activities, with end-to-end responsibility for the qualification and validation of equipment, installations, and measurement systems.
Functionally reporting to the Quality Assurance Manager, the candidate will independently manage validation and requalification processes, ensuring full compliance with internal procedures and applicable regulatory standards.
This is a highly visible position with a direct impact on product quality and operational excellence.
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
- Analysis and evaluation of KPI and data monitoring to ensure a continuous improvement of the quality system
- Deviation, Quality investigations, CAPAs and Change Control management
- Definition of Standard Operating Procedures (SOP) and GxP-related documentation along with other relevant units/department Managers
- Contribution to the implementation of innovative industrial Projects in line with company strategic timelines
- Involvement both in self-inspections and inspections
- Drawing of validation protocols and final validation and qualification reports providing rationale, , operational methods and registration forms according to the relevant guidelines
- Definition of staff training plans and coordination of training activities. Training must be based on protocols and operational procedures, and tailored to personnel involved in qualification 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
- Coordination with internal stakeholders to ensure respect of qualification schedules, especially during shutdown periods
- Supervision, review, and approval of qualification protocols issued by third-party entities, in collaboration with the Quality Assurance Manager
- Definition of contracts with internal and external suppliers for qualification services of machines, systems, and processes
- Ensure the correct maintenance of the technical documentation archive, including both current and obsolete documentation
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.)
- Coordination, review, and approval of changes related to machines and systems, and the resulting qualification activities
- Coordination of decommissioning activities of equipment and systems, according to company procedures
- Active contribution to defining operational procedures and documents required to maintain GMP compliance, in collaboration with department heads
Nice to have:
- Management of audits by authorities, customers, certifying bodies
- Quality Risk