Head of Quality and Pharmacovigilance

Full Time
Germany
Posted 1 month ago

With a planned turnover of more than EUR 760 million for the current financial year, this is one of the world’s leading companies in the pharmaceutical and healthcare sector. The group’s services encompass the entire chain of the development and manufacture of all current dosage forms and product groups in the field of medicinal and food supplements. With high quality standards, innovative technologies and a clear future orientation, the company has become Europe’s market leader in business-to-business. The company is represented in 27 countries worldwide in eleven countries more than 4,400 employees contribute to the success of the company.

Responsibilities

  • Assuming responsibility for the quality assurance system, as well as the management, maintenance and continuous further development of the global pharmacovigilance system
  • Ensure compliance with the documentation, information and reporting obligations in the field of pharmacovigilance, as well as all legal, company-internal and contractual guidelines on drug safety
  • Ensure the planning, preparation and execution of inspections and audits
  • Support to the medical approval department in connection with the application, modification or renewal of authorizations
  • Creation, review and approval of SOPs
  • Assessment of PQRs, complaint statistics and results from the ongoing stability assessments
  • Monitoring of change control, deviation and OOS procedures
  • Monitoring of the preparation of responsibilities, contracts for services and risk assessments, e.g. with regard to elemental impurities
  • Leadership of the PV team
  • Activity as QP

What should you bring along?

  • Approbation as a pharmacist and knowledge according to § 15 AMG as a qualified person according to § 14 AMG (Qualified Person)
  • Experience working as a qualified person, as well as in the field of drug production or drug testing
  • Analytical thinking and understanding for technical and complex questions
  • High professional competence and knowledge of the legal requirements in the field of drug production, testing and approval
  • Fluent in English, written and speaking
  • High degree of self-initiative and quality awareness
  • Traveling in a global company required

On offer is a growth-oriented, dynamic and international environment in which exciting cross-site tasks as well as active co-operation opportunities are offered. If you are interested in these tasks in a future-oriented company with great market potential, then apply today.

Send your CV to Jgregory@acr-uk.com using the job title as the email subject line