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Associate Quality Manager/rp
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Location: Vienna (Hybrid Working)- Job type: Permanent
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- Responsibility for planning, coordination, implementation and monitoring Quality Assurance activities across the Austria and CEE region- Troubleshooting of quality issues arising in Austria and CEE countries;
- Preparation and execution of internal/external GDP/GMP- audits
- Oversight on Complaints, recall handling and Out of Stock-reporting and main contact person for the Austrian competent authority
- Implementation of new processes for Mundipharma (e.g., Change Control) for the region in cooperation with Head of EU Quality and global quality systems.
- Preparation for inspections and audits conducted by external parties
- Preparation of Audits and CEE support in Audits / inspections
- Product Quality Review
- Management of the quality assurance system (in accordance with the current version of EU GDP/GMP guideline as well as national legislations)
- Management of CAPAs (CAPA tracking CEE and follow up) and Deviations
- Management of Quality Agreements, Technical Agreements and Contracts, Maintenance of licences
- Development of required Standards Operating Procedures (SOPs), Quality Manual and SMF
- Oversight on Management of qualification and validation activities (e.g. computer systems)
- NMVO: Serialization contact person, Alert Handling for Mundipharma Products, contracts in the region (maintenance)
Qualifications
- University degree in Pharmacy, Human or Veterinary Medicine, Dentistry, Chemistry, Biology or food
- and biotechnology)
- Proven experience working in quality management in relation to wholesalers
- Strong background with GDP in the pharmaceuticals industry
- Previous Designation as General Manager according to the Trade Law for the respective businesses and OR Qualification to act as such.
- At least one year of qualified employment in one or more companies, which have been granted a wholesale license.
- High degree of professionalism and in accordance with the company’s code of Ethics and Business Conduct.
What we offer in return- opportunities for learning & development- 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, centred around Integrity and Patients-Centricity, are at the heart of everything we do.
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Additional Job Description:
Primary Location:
AT Vienna
Job Posting Date:
2024-11-25
Job Type:
Permanent
