Career · Quality Management
Pharmaceutical Quality Management Specialist and GMP Consultant (m/f/d)
To strengthen our team, we are looking for a pharmacist, chemist or natural scientist with experience in pharmaceutical quality management, or an experienced practitioner in 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.
At both sites, we hold the necessary manufacturing authorisations for batch release and carry out batch certification of clinical investigational medicinal products as well as of authorised medicinal products. This sets us apart from most consulting firms. This offering is complemented by our own laboratory for the chemical-pharmaceutical analytics 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 clinical investigational medicinal products
- Advising our clients on GMP matters and quality-relevant systems and processes
- Supporting clients in building, maintaining and optimising their quality management system
- Internal and external support in the preparation of SOPs and other quality management system documents
- Internal and external advice on the validation of software, manufacturing processes and analytical methods
- Internal and external advice on qualifications
- Supporting regulatory inspections and internal client audits
- Planning, conducting and following up audits as part of supplier qualifications
What you bring with you
- Completed university degree in natural sciences, ideally pharmacy, or training in the pharmaceutical field with several years of relevant experience
- Sound knowledge of the applicable guidelines and laws of the pharmaceutical industry, including the EU GMP Guide, AMG and AMWHV
- Experience in quality management at pharmaceutical companies
- Familiarity with the process of validations and qualifications
- Enjoyment of working on new and changing subject areas, along with good analytical and organisational skills
- Strong communication skills, initiative and sense of responsibility
- Enjoyment of working in a team
- Confident written and spoken German and English
- Willingness to travel occasionally to visit clients
What you receive
- A permanent position, available part-time from 50 percent or full-time as preferred
- A varied role
- Attractive remuneration
- Thorough induction and ongoing further training
- Flexible working hours that take client requirements into account
- The option of working from home and mobile working
- Company pension provision
- A flat hierarchy and an appreciative team culture
