Biologist as Head of Department Qualification/Validation - Quality Assurance

Biologist as Head of Department Qualification/Validation - Quality Assurance

BioNTech

Idar-Oberstein, Germany

Here, you’ll achieve greatness

At BioNTech IMFS, you accomplish an important contribution to the manufacturing of cellular medical products and gene therapeutics for the use in clinical studies. Your duties in detail are:

  • Management of the Department Qualification/Validation with 3 employees;
  • Creation, review and release of GMP-relevant regulations, documents and contracts in relation with Qualification/Validation;
  • Creation of the Validation Master Plan;
  • Supervision of Qualification and Validation measures in the departments of production, quality control and CS (QA-Oversight);
  • Creation of overall SOPs and protocols for the conduction of qualification and validation measures;
  • Processing of deviations, changes and CAPA-measures;
  • Training of the employees in qualification and validation relevant topics.

What you have to offer:

  • Completed scientific university degree or similar qualification;
  • Profound knowledge of the national and international GMP regulations for clinical test samples, ATMPs and authorised medicines;
  • At least 5 years practical experiences in the field of quality assurance especially in the field of audits, contracts, supplier qualification and authorities communication;
  • Extensive practical experiences in the field of Qualification (RA, DQ, IQ, OQ, PQ) and Validation under GMP;
  • Reliability, team spirit and organizational talent;
  • Safe handling of MS Office programs and very good command of German and English spoken and written.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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