Dipharma SA is a successful company made of dynamic, experienced and proactive people who share the same values and strongly feel they are doing something that matters to them and to the community. We are committed to give access to affordable and potentially improved generic drugs to patients affected by rare metabolic disorders.

To maintain the Company Quality System updated and a high level of GMP and GDP compliance, we are looking for a QA Specialist.

The QA Specialist will be integrated in the Quality Assurance Team and will report to the Quality Assurance Manager / Technical Responsible. He or she will work with the team to maintain a high level of quality in accordance with Site SOP’s, regulatory guidelines and cGXP compliance requirements.

Key Responsibilities

• Share best practices, knowledge, challenges and lessons learned across the whole Dipharma’s team in order to improve the performance of quality globally
• Ensures compliance of the site to the Quality Systems and manages the on time completion of Quality System actions, investigations, CAPA, change control, and other Quality System documentation (e.g. Site Master File, Validation Master Plan, Technical Agreements etc)
• Participate in customers’ audits and regulatory inspections
• Draw up/review/approve SOPs
• Management of deviations, CAPAs, Change Controls
• Be involved in the activities related to suppliers’ qualification and customers/distributors’ qualification.

Qualifications

• Bachelors Degree required, preferably with a minimum of five (5) years of experience in a quality position in the pharmaceutical industry
• High level of English, both written and spoken
• Experience with pharmaceutical processes, techniques, and quality assurance expectations
• Must have working knowledge of applicable cGMPs/GDP and compliance topics
• Working knowledge of audit/inspection management, response writing, change control and CAPA management programs strongly preferred
• Expertise with SAP, ADIUTO and TraceLink is a plus
• Knowledge of product release and validation support
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If interested, send your application to michela.carcano@dipharma.ch. Applications not in line with the requirements will not be followed up.