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Job

Qualified Person/ Junior Qualified Person

  • Location

    Schorndorf, Germany

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    €100,000-€120,000

  • Contact:

    Jonathan Olmedo

  • Contact email:

    j.olmedo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    26 days ago

  • Expiry date:

    2019-11-17

Qualified Person/ Junior Qualified Person role! 

Our Client in Schorndorf is the flagship EU manufacturing location for large scale reliable supply of complex controlled release oral solid dose forms through state-of-the-art fluid bed granulation and hot melt extrusion capabilities, integrated development, commercial manufacture, and packaging.

 

Requirements:

  • Pharmacist with approbation as a pharmacist or comparable
  • Suitability for designation as a Qualified Person according to AMG §15 (1) and (4)
  • Ideally, experience with clinical investigational medicinal products
  • Several years of professional experience in the GMP-regulated environment
  • Work experience in quality assurance as well as audit experience desired
  • Assertive personality; Flexibility and resilience; team Player
  • Fluent German and English spoken and written

 Responsibilities:

  • Certification of drug batches as a knowledgeable person
  • Participation in the development, production, testing, and approval of medicinal products as a qualified person in accordance with §§ 13, 15 AMG
  • Information and advice to employees, physicians, and other healthcare stakeholders through a product risk assessment of drugs
  • Keeping a continuous register of all released batches in accordance with § 19 AMG in conjunction with § 17 AMWHV
  • Final evaluation and approval of deviations and complaints
  • Auditing of manufacturing and testing facilities
  • Ensuring the proper retention of restitution patterns
  • Participation in the supervision of customer audits and official inspections

 

Interested? Click on the apply button below!