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Life Sciences

QA Manager (m/f/d)

Hessen, Frankfurt Am Main

For our client, an international pharmaceutical company in Frankfurt area, we are looking for a QA Manager (m/f/d).

Ihre Aufgaben

 

  • The QA Manager Projects is responsible for ensuring compliance and act as quality advocate in the CMC projects he/she is assigned.
  • Specifially he/she is responsible for ensuring effective quality standards are followed within the project (CMC strategies, project plans and deliverables) and at the interface to CMOs.
  • In the respective project team he/she provides quality and compliance knowledge (either by own experience or by being able to acquire the required information by their network)
  • They are focal point and lead in conducting investigations and solving of quality events (OOS, deviations, RQN, technical complaints).
  • Additionally they are responsible to ensure integration and application of quality risk management principles into the project
  • Set-up and coordination of quality agreements with respective CMOs and contract labs.
  • Full project team member in CMC team for assigned project responsible for all quality/compliance aspects
  • Identification of quality/compliance risks and bringing them to the table. Definition of mitigation plan in the team and ensure follow up of agreed action plan
  • establish and maintain up-to-dateProject Quality Risk Mapping
  • In scientific discussion provide quality/compliance perspective
  • Evaluate project proposals and scenarios taking into account technical and regulatory constraints
  • In the interface to CMOs support contract negotiations related to compliance aspects, lead on compilation of quality agreements, provide audit support
  • In late stage development, ensure quality aspects of work packages process characterization,

 

Ihr Profil

 

  • PhD or Master in Science (University), Chemistry, Biochemistry, Biotechnology, Chemical engineering or Pharmacist
  • 7+ years of professional experience in quality related roles of increasing responsibility in development and/or manufacturing of pharmaceutical products, preferable experiencewith projects in late stage development/submission and with CMO involvement
  • Excellent knowledge of cGMP requirements,internal and authority guidances, quality systems and quality management systems
  • Experience with outsourcing of activities and management of CMOs
  • Experience as auditor is appreciated
  • Fluency in English, verbally as well as in writing

Job ID: 11234

IHR ANSPRECHPARTNER

Lillian Fatehi

Recruiterin
069 – 66 80 50 646

ÜBER APRIORI

APRIORI ist eine spezialisierte Personalberatung. Wir vermitteln kompetente Fach- und Führungskräfte aus den Bereichen IT & SAP, Life Sciences und Engineering.

069-668050175

FRANKFURT

APRIORI – business solutions AG
MesseTurm 24. Etage
Friedrich-Ebert-Anlage 49
60308 Frankfurt

Tel. (069) 66 80 50-175
Fax (069) 66 80 50-400

BERLIN

APRIORI - business solutions AG
Atrium Tower 7. Etage
Eichhornstraße 3
10785 Berlin

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