Description
Quality Project Specialist NOVJP (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Support the supervisor in the timely release of GMP relevant documents
- Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP in R&D
- Perform review of GMP groups (e.g. manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, analytical raw data, qualification documents etc.)
- Clarify simple deficiencies in GMP documents with the line unit experts in own responsibility
- Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up
- Provide support for quality relevant electronic systems (e.g. GLIMS, TQW, TEDI, ESOP)
- Write and complete GMP relevant documents in own area of responsibility (e.g CoAs, CoCs , BRR sheets, test scripts, SOPs)
- File and archive documents owned by Quality Assurance (e.g. audit reports, CoAs, CoCs, BRR sheets etc)
- Act as a contact person to the needs of the line unit (e.g. CoA needs from different customers, such as e.g. CMC, Qualified Persons; distribution of TEDI documents to external customers, etc.)
- Support the line function in the use of GMP relevant IT tools and processes
- Collaborate with other associates to support the service function of Quality Assurance
- Contribute to the evaluation of new tools (e.g. IT systems, processes)
- Participate in knowledge exchange in R&D
- Participate in training of new and temporary employees
Main qualifications
- Working experience in Quality Assurance and GMP standards gained from previous projects, including ethical, health safety and environment (HSE), and information security (ISEC) standards
- Good working knowledge of supporting projects with agreed quality and delivery dates, passing of internal and external inspections
- Good knowledge of Standard Operating Procedures and quality relevant electronic systems (e.g. GLIMS, TQW, TEDI, ESOP)
- Experience in training employees
Main advantages:
- Varied tasks in a renowned company
- Flat hierarchies
- 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:
Juliane Grewenig
Referencenumber:
Make contact:
Phone:
Email: