Responsable Person - GMP/GDP

Randstad (Switzerland) Ltd.

  • Publication date:

    15 June 2024
  • Workload:

    100%
  • Contract type:

    Unlimited employment
  • Place of work:

    Basel

Responsable Person - GMP/GDP

job details
For our client based in Basel and specialized in pharma area, we're looking for a QA Manager - Responsable Person


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 language skills is a plus.
For our client based in Basel and specialized in pharma area, we're looking for a QA Manager - Responsable Person


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 language skills is a plus.

Margot Ferraton