Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

QP-Swiss based start-up Pharmaceuticals-Munich

  • Location

    Munich

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Rob Steel

  • Contact email:

    r.steel@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2020-10-25

  • Startdate:

    ASAP

Hamlyn Williams have partnered up with an innovative swiss start-up pharmaceutical company that is going through a phase of growth. Essentially the company develops and manufactures products in novel forms with delivery on an international scale.

Due to company growth, they are looking for a QP to join their quality assurance team on a permanent basis. Roles and responsibilities include but are not limited to:

  • Performance of the tasks as a Qualified Person in accordance with § 14 AMG (German drug law) for the manufacture and testing of externally manufactured medicinal products
  • Batch certification for the marketing of medicinal products according to EU GMP guidelines, Annex 16
  • Coordination, organization and execution of Audits
  • Creation, review and negotiation of Technical Quality Agreements with contract manufacturing organizations and service providers
  • Qualification of suppliers and service providers
  • Processing, review and approval of Deviations, CAPAs, Complaints and Change Requests Assessment of PQRs
  • Creation and review of SOPs and GMP/registration documents
  • Ensure compliance with the EU guidelines for Good Distribution Practice (GDP) and the requirements of the narcotics act
  • Coordination of product launches from QA perspective
  • Maintenance and further development of the Quality Management System
  • Participation in Customer audits and Authority inspections and follow-up of observations

To be considered for this role, you will be:

  • Fluent in German and English
  • Certified QP-Newly qualified QP’s will be considered
  • Ideally come from a pharmacist background but natural sciences background can also be considered
  • Minimum of 3 years in QA/QC

Attach an updated CV to be considered