Quality Assurance Officer

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Quality Assurance Officer

Apply locations: CH Basel

Job type: Full Time

Posted on: 2 Days Ago

Job Requisition ID: JR1719

Join us and make a difference when it matters most!

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

Role and Responsibilities:

Quality Management System Oversight

1. Accountable for an effective QMS being established/implemented, maintained and operated in line with current GDP & GMP requirements, local regulatory standards, and Mundipharma standards for all relevant product classes.
2. Perform and follow-up activities related to Quality Management Systems.
3. Accountable for maintenance and operation of local GxP change controls, deviations and CAPAs.
4. Accountable for appropriate receiving and handling of complaints, (suspected) product defects, temperature excursions and (suspected) falsified medicinal products, security incidents, product recalls, adverse drug reactions and other safety information.
5. Support Independent Associated Companies regarding quality-related topics.
6. Support Quality Management Reviews and other regular reports to upper management.

Outsourcing and Technical Agreements

1. Maintain and update Technical Quality Agreements with Suppliers and Customers.
2. Escalation of significant quality issues to the superior.
3. Inspections/audits and quality defects.
4. Support and perform adequate Supplier, Customer and Service provider qualification activities including audits.
5. Implement and assure an adequate Self Inspection system.
6. Management of Third Party providers by:
7. Writing new Technical/Supplier agreements.
8. Reviewing Periodic Quality Reviews.
9. Review of third party Change Control, Deviations, CAPA and Complaints using risk management principles.
10. Participate and work collaboratively with internal and external stakeholders on issue resolution to ensure product quality, compliance and supply.
11. Establish effective partnership and relationship with third parties.

What You’ll Bring

1. Bachelor’s degree in chemistry or related field.
2. Professional experience related to pharmacy.
3. A minimum of 2 years’ experience in GxP (e.g. GMP, GDP).
4. GDP knowledge of pharmaceutical products, medical devices and narcotic/psychotropic products, cosmetics, biocides, foods, etc.
5. Proficient in establishing and maintaining a GDP / GMP Quality Management System.
6. Trained auditor for GDP/GMP (or at least acting as co-auditor).
7. Experience in a QA role, particularly in managing pharmaceutical Quality Systems.
8. Experience in managing outsourced activities and third-party service providers.
9. Experience hosting GxP inspections.
10. Experience working in an international setting.
11. Experience working with narcotic/psychotropic products.

Knowledge and Skills

1. Desirable – Knowledge in national and international pharmaceutical legislation.
2. Proactive, pragmatic, independent, organized and self-confident.
3. Customer focused with cross-functional thinking and behavior.
4. Works collaboratively maintaining good working relationships with cross-functional teams and partners actively participating in team success.
5. Proficient in the use of Microsoft Office applications.
6. Competent in the use of databases (preferred).
7. Experience in Supplier Management (preferred).
8. Fluent in spoken and written English. Regional language (German) preferred.

What We Offer in Return

1. Flexible benefits package.
2. Opportunities for learning & development through our varied programme.
3. Collaborative, inclusive work environment.

Diversity and Inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.

About Mundipharma

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.

Join our talent pool

If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.

Additional Job Description:

Primary Location: CH Basel

Job Posting Date: 2025-02-17

Job Type: Fixed Term Contract (Fixed Term)

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