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Job

Qualified Person

  • Location

    Munich

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Luisa Namadila

  • Contact email:

    l.namadila@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    15 days ago

  • Expiry date:

    2021-05-22

Hamlyn Williams have partnered with a reputable pharmaceutical company with an international footprint who are undergoing a phase of growth.

The company are global leaders in advanced drug delivery technologies with a focus on modified release on oral forms and dispersible oral forms.

As a result of such growth, a QP is needed on a perm basis in Munich with a lucrative salary on offer and flexible working hours

Roles and responsibilities include but are not limited:

  • Performance of the tasks as a Qualified Person in accordance with § 14 AMG (German drug law) for the manufacture and testing of externally manufactured medicinal products
  • Batch certification for the marketing of medicinal products according to EU GMP guidelines, Annex 16
  • Coordination, organization and execution of Audits
  • Creation, review and negotiation of Technical Quality Agreements with contract manufacturing organizations and service providers
  • Qualification of suppliers and service providers
  • Processing, review and approval of Deviations, CAPAs, Complaints and Change Requests
  • Assessment of PQRs
  • Creation and review of SOPs and GMP/registration documents
  • Ensure compliance with the EU guidelines for Good Distribution Practice (GDP) and the requirements of the narcotics act
  • Coordination of product launches from QA perspective
  • Maintenance and further development of the Quality Management System
  • Participation in Customer audits and Authority inspections and follow-up of observations

Successful candidates will have:

  • Minimum of 5 years in QA GMP
  • QP qualified
  • Pharmaceutical background
  • German fluency is preferable but not essential
  • Some line management experience

Attach an updated copy of your resume to be considered