Responsible Person - GMP/GDP
job details
For our client based in Basel and specialized in pharma area, we're looking for a QA Manager - Responsible Person
Responsibilities
Additional Responsibilities:
Profile
Responsibilities
- Support Quality activities in LATAM and MMG operational areas, acting as the Responsible Person for LATAM GmbH and Medical GmbH.
- Execute Quality Management system activities on behalf of IACs to ensure compliance with GxP legislation.
- Provide oversight of Quality Assurance activities for third-party manufacturers, packaging operations, and other outsourced entities in Consumer Health and Ethical areas.
- Conduct Supplier Assurance activities to maintain the qualification status of raw material and packaging suppliers.
- Offer Quality advice and support to internal and external stakeholders.
- Implement and maintain a Quality Management System, complying with relevant regulations.
- Act as the Responsible Person for LATAM GmbH and Medical GmbH, and as Deputy Responsible Person for MLG, MAG, MNE MEA, and MMCO.
Additional Responsibilities:
- Lead Basel Quality Management System activities, including Complaints, Change Control, Recall, Audits, Self-Inspections, and Training.
- Lead Supplier, Customer, and Service provider qualification activities, including audits.
- Implement and update Technical Quality Agreements with Suppliers and Customers. Support and lead Quality Management Reviews and regular reports to upper Management.
- Assist Independent Associated Companies with Quality-related topics.
- Escalate significant Quality issues to superiors.
- Serve as a local expert for GxP-related questions.
- Manage Third-Party providers by updating agreements, conducting Quality Review Meetings, ensuring regulatory documentation, and reviewing stability data.
- Review third-party Change Control, Deviations, CAPA, and Complaints using risk management principles.
- Participate collaboratively with internal and external stakeholders to resolve issues and ensure product quality, compliance, and supply.
- Establish effective partnerships and relationships with third parties.
Profile
- Degree in natural science (Chemistry, Pharmacy, Biology, etc.) or higher.
- Minimum 5 years of QA experience, preferably in a managerial role in the pharmaceutical industry.
- Experience in Quality Supplier Management.
- Excellent knowledge of GMP and GDP regulations for drugs, devices, cosmetics, etc.
- Fluent in spoken and written English & German.
Margot Ferraton
- +41 58 201 54 41
- Geneva Professionals Health Care & Life Sciences
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