Associate Quality Manager/RP

Posted 2 Days Ago
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Vienna
Entry level
Healthtech • Pharmaceutical
The Role
The Associate Quality Manager/RP will oversee Quality Assurance activities, troubleshoot quality issues, prepare for audits, manage the quality assurance system, and ensure compliance with GDP/GMP guidelines across Austria and the CEE region.
Summary Generated by Built In

For this position, a collective agreement entry-level salary based on full-time employment amounts to €2,818.00 gross per month. We offer a market-competitive overpayment depending on qualifications and experience.

  • Location: Vienna (Hybrid Working - 1100 Wien)

  • 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

  • Fluent in German and English
  • 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
  • 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. 

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:

    AT Vienna

    Job Posting Date:

    2024-11-25

    Job Type:

    Permanent

    The Company
    Cambridgeshire
    2,154 Employees
    On-site Workplace
    Year Founded: 1952

    What We Do

    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 and debilitating disease areas.

    Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great place to work.

    For more information visit www.mundipharma.com

    See our community guidelines: mundipharma.com/social-media-community-guidelines

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