Manager Regulatory Affairs und Quality Assurance (m/w/d)

Ort: München, Bayern, Deutschland
Gehalt: a. A.
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
Jetzt bewerben

Manager Regulatory Affairs & Quality Assurance (m/w/d)

This position is to be filled full-time (40 h/week).

This tasks are awaiting you:

  • create, review, maintain and track Standard Operating Procedures for compliance with GMP and GDP regulatory requirements, guidelines, and industry standards
  • train employees on SOPs, GMP, GDP and quality related matters
  • organize and supervise the execution of the QMS
  • coordinate and participate during the assessment and evaluation of suppliers, CMO's, CDMO's and other service providers of the company
  • conduct preaudit, audits and assist with regulatory inspections, follow up on audit responses and assist in verifying CAPA effectiveness
  • compilation and establishment of technical agreements/quality agreements
  • to record, administer and follow up deviations, customer complaints, and change control
  • to review, analyse, and recommend approval for data generated from manufacturers and/or laboratories to ensure that the products and processes, raw materials, components and validations, are appropriately analysed, documented and approved/released
  • to release APIs and other products which need not to be released by the company's QP
  • Exchanges with the competent Authority
  • Oversee storage of pharmaceutical products in accordance with §7 AMWHV
  • Documentation and archiving of protocols/documents from audits, manufacture, packing and storage
  • confirms the compliance of each batch of bulk medicinal products to the requirements provided
  • Auditing of suppliers/contract manufacturers and contract warehouses in order to ascertain their GMP/GDP compliance
  • Training of internal and external employees considering the activities in ensuring quality of stored pharmaceutical products

What you need to get startet:

  • Natural scientific background (Chemistry /Medicinal Chemistry/Pharmaceutical
  • chemistry/Biology/Pharmacist degree)
  • Min 5 years, ideally 10 years' experience across APIs, ideally also in Formulations
  • RA experience: API DMF/CEP submissions
  • QA experience: General knowledge in API, Pre-formulation and pharmaceutical technology.SOP's document drafting, as well as API QA releases. Very good understanding of key
  • business processes within supply chain, product lifecycle processes.
  • General knowledge and experience in cGMP, GDP, ICH, QA system, internal compliance and
  • Audits: Ability to perform and compile audits of manufacturing sites (mainly API) to ensure
  • the compliance of our suppliers. Ideally certified auditor.
  • Fluent in German and English
  • Availability for travels in Europe and abroad (Asia, India)

Your contact person for this position is Ms Franziska Mayr

You can reach her directly at:

T: +49 (0)89 5519 7774

M: f.mayr(at)progressive.de

Jetzt bewerben