Beschreibung
Associate Quality Manager - NOVJP (m/f)
Reference: -en
Start: asap
Duration: 14 MM++
Main tasks:
- Perform review of GMP relevant documents for compliance with SOPs across several customer groups
- Perform review and approval of GMP relevant documents derived from approved sources (e.g. analytical working sheet templates, GLIMS specifications)
- Negotiate deficiencies in GMP documents with the line unit
- Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up
- Propose and survey implementation of agreed preventive actions
- Act as contact person for QA questions of quality relevant electronic systems (e.g. IMOS, GLIMS, TQW, QP database, TEDI, ESOPS, Pathlore), and/or as a contact person to the needs of the line unit (e.g. CoA needs from different customers; TEDI formats, etc.)
- Write and complete GMP relevant documents in own area of responsibility (e.g CoAs, CoCs , BRR sheets, test scripts, SOPs with extended applicability)
- Perform statistical interpretation of trending data collected by QA (e.g. in TQW or audit database) and compile trending reports and suggest conclusions
- Evaluate new QA tools (e.g. IT systems, processes)
- Participate in training and coaching of new and temporary employees in QA and from associated line functions
Main qualifications
- Basic degree in scientific, laboratory, manufacturing or relevant discipline (e.g. apprenticeship, Bachelor or equivalent; Associates of Arts degree)
- At least profound experience in a corresponding line unit function (e.g. laboratory, manufacture, packaging, IT)
- Negotiation and communication skills to address GMP related questions with the line unit experts, in order to maintain GMP records in a compliant status
- Sound scientific, technical and regulatory knowledge in a specific area
- Detailed knowledge of relevant GMPs, working knowledge of safety and environmental regulations and guidelines
- Good knowledge of drug development
- Good organizational skills
- Proven ability to analyze and evaluate GMP compliance
- Knowledge and flexibility to work with relevant IT systems
Main advantages:
- A very renowned company
- Interesting tasks in a multinational environment
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Svenja Weiß
Referencenumber:
Make contact:
Email: