Global Quality Assurance Manager
Vor 7 Tagen
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products.
OverviewWe have proven expertise in bringing customer products to market faster, enhancing product performance, and ensuring reliable clinical and commercial product supply.
SalaryThe estimated annual salary for this role is between CHF 90,000 and CHF 120,000 depending on experience.
About the RoleThe Deputy Responsible Person acts as the back-up for the Responsible Person, upholding Cham's Quality Management System, and leading local EHS initiatives and guidelines.
- Act as the Deputy RP for foreign trade pursuant to section 3 and article 23, of the Medicinal Products Licensing Ordinance (Arzneimittel-Bewilligungsverordnung "AMBV"; Classified Compilation of Federal Legislation "SR" 812.212.1).
- Co-manage the Cham Quality Management System, its compliance and continued effectiveness.
- Ensure that the medicinal products are distributed in accordance with the requirements under the Good Distribution Practice (GDP).
- Collaborate with manufacturing sites on regulatory inspection readiness and inspection management, as well as regulatory responses if needed.
- Monitor and facilitate activities required to guarantee the qualified status of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements.
- Champion EHS compliance in Cham, maintain & uphold corporate & local EHS standards and develop an EHS security roadmap with corporate stakeholders.
- Manage regulatory inspections (e.g Swissmedic) and maintain internal audit self-inspections compliance.
To be successful in this role, you will need:
- Bachelor's degree in life science (Biology, Chemistry, Pharmacy or a related field).
- At least 8 years of experience in GMP/GDP sector, with a strong preference for sterile manufacturing experience.
- Swissmedic registration is a strong asset.
- Fluent in English and strong knowledge of German.
- Excellent communication and presentation skills, with proven ability to present information to diverse audiences.
- Experience collaborating in international and fast-paced manufacturing environments.
- Demonstrated understanding of ERP systems (JDE, SAP, ...) is a plus.
We offer a dynamic and multicultural environment in Cham, with opportunities for personal development within an international company.
You will benefit from a competitive annual salary, pension plan, and 25 days of legal holidays.
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