Quality Assurance Consultant (m/w/d)
- Siemensdamm 62, 13627 Berlin, Germany
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
- Assist clients in identifying processes that require quality management measures.
- Support clients in setting up and maintaining quality compliant systems and processes.
- Function as “responsible person” according to 52a AMG or as “BtM representative” or as “qualified person” according to 14 AMG or as a quality management representative for our clients.
- Create relevant SOP’s in accordance with legal requirements and applicable standards.
- Verify or prepare documents for quality agreements.
- Prepare government inspections and audits of client and contract manufactures.
- Submitting applications for dealer licenses or drug licenses for clients and support/advise contract manufacturers/CMOs.
- Advise clients on quality issues and compliance/implementation of quality guidelines.
- Successfully completed a university degree in a life science, ideally in pharmacy
- Mother Tongue in German; and fluent in English
- Ideally have exercised the functions of a “Responsible Person” according to 52a AMG or as a “BtM Representative” or as a “Qualified Person” according to 14 AMG or have professional experience as Quality Management Officer.
- Thorough knowledge of regulatory guidelines: GDP, GMP, GCP, ISO9001 or ISO 13485.
- Multiple years of experience in the quality management of a pharmaceutical company or a contract manufacturer or medical device manufacturer.
- Strong Analytical and Organizational skills, as well as problem solving and consulting skills.
- In-Depth knowledge of the relevant national and international standards and guidelines in pharmaceutical and medical device compliance law. In addition, you are ready to expand your knowledge in this area continuously.
- Very good MS Office skills.
- Excellent Communication skills.
- Perform a variety of interesting projects and varied tasks.
- Cooperation with various clients from the pharmaceutical sector.
- A flexible, dynamic and pleasant working atmosphere.
- Opportunities for learning and development.