Careers · Quality Management
Pharmaceutical Quality Management Specialist and GMP Consultant (m/f/d)
To strengthen our team, we are looking for a pharmacist, chemist or scientist with experience in pharmaceutical quality management, or an experienced practitioner from this field.
A&O Pharma GmbH is a growing company with sites in southern and northern Germany. We advise and support pharmaceutical companies in implementing, maintaining and optimising their processes within the pharmaceutical quality system.
We hold manufacturing authorisations for batch release at both sites and carry out batch certification of investigational medicinal products and authorised medicinal products. This sets us apart from most consulting firms. Our services are complemented by our own laboratory in Itzehoe for the chemical and pharmaceutical analysis of medicinal products and active substances.
Your responsibilities
- Performing quality assurance tasks within A&O Pharma GmbH
- Preparing documentation for the batch release of medicinal products and investigational medicinal products
- Advising our clients on GMP matters and quality-related systems and processes
- Supporting clients in setting up, maintaining and optimising their quality management system
- Supporting the preparation of SOPs and other quality management documents, internally and for clients
- Advising on the validation of software, manufacturing processes and analytical methods, internally and for clients
- Advising on equipment and facility qualification, internally and for clients
- Supporting regulatory inspections and internal client audits
- Planning, conducting and following up audits as part of supplier qualification
What you bring
- University degree in a science subject, ideally pharmacy, or vocational training in the pharmaceutical sector with several years of relevant experience
- Sound knowledge of the applicable pharmaceutical guidelines and legislation, including the EU GMP Guide, AMG and AMWHV
- Experience in quality management at pharmaceutical companies
- Familiarity with validation and qualification
- Enjoy getting to grips with new and varied topics, with good analytical and organisational skills
- Strong communication skills, initiative and a sense of responsibility
- Enjoy working in a team
- Fluent written and spoken German and English
- Willingness to travel to clients occasionally
What you get
- A permanent position, part-time (at least 50 per cent) or full-time, as you prefer
- A varied role
- Attractive salary
- Thorough induction and ongoing training
- Flexible working hours that take client requirements into account
- Option to work from home or remotely
- Company pension scheme
- Flat hierarchy and a team culture of mutual respect
