Qualified Person & Director QA GMP (m/f/d)

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort

 

To support their expanding Quality Assurance Team we are looking for a:

Qualified Person & Director QA GMP (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    München

  • Art der Anstellung:

    permanent

  • Kennziffer:

    26655

  • Aktualisierung:

    2021-09-09

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Your tasks

  • Ensure that the (investigational) medicinal products have been manufactured and checked in accordance with applicable laws and in accordance with EU-Good Manufacturing Practice (GMP) principles and guidelines
  • Evaluation, confirmation and certification of batches on the basis of GMP compliant manufacture and testing according to the EU GMP guidelines, Annex 16
  • Act/perform the tasks of a Qualified Person (QP) in accordance with Annex 16 of the EU GMP Guidelines and the Code of Practice for Qualified Persons for products manufactured or packaged by contracted manufacturing organizations
  • Review of batch records and disposition of batches as a QP under EU Directive 2001/83/EC and comply with all the applicable GMPs, national legislation and requirements of the relevant Quality Agreement
  • Monitoring the compliance with pharmaceutical regulations
  • Evaluation of deviations and changes
  • Review and approval of Quality Assurance Agreements
  • Support, develop and maintain the Quality Management System (QMS), and drive continuous improvement within the QMS
  • Perform internal audit/self-inspections
  • Perform vendor selection, maintenance & for cause audits (contract manufacturers, testing facilities, raw material suppliers, etc.)
  • Primary resource for pharmaceutical product release, ensures batches meet manufacturing authorization requirements and fulfil requirements in Quality and/or Technical agreements as applicable
  • Assist in the drafting and approval of master batch manufacturing records
  • Review and approve SOPs, validation protocols, change requests, annual Product Quality Reviews and Planned Process Variations in accordance with company procedures and guidelines
  • Provide support in the preparation and hosting of regulatory inspections

Ihre Qualifikation

  • Degree in pharmacy with license to practice as a pharmacist or equivalent
  • Qualification/legibility to perform the duties as QP in accordance with §15 AMG
  • Three or more years’ experience performing the duties of a QP with expertise (practical experience) in the release of multiple licensed and unlicensed dosage forms (biologics and sterile product manufacture and supply)
  • Thorough understanding of US, EU and local regulatory requirements governing the duties/role of a QP, sterile (biological) product manufacture, testing and release
  • Previous experience in implementation of quality management systems and processes supporting the development of large molecule biologics
  • Thorough understanding of national and international laws, regulations and guidelines regarding GMP
  • Good understanding of the EU Clinical Trial Directive
  • Several years of professional experience in a GMP-regulated environment
  • Lead Auditor with expertise in IT systems audits, excipient/raw material suppliers, Contract Manufacturing Organizations, Contract Distribution and Manufacturing Organizations and wholesale dealers/equivalent organizations
  • Fluent in written and verbal English and German
  • Excellent organization and communication skills
  • Assertive and team-oriented personality
  • Highly motivated, self-driven and dependable
  • Champions a top down quality culture within the business

Your contact person

Beate Aschoff
Senior Personalberaterin

Address

Optares Medical GmbH & Co. KG
Beate Aschoff
Heiligengeist Höfe 8
26121 Oldenburg