Description
- As a modern company, our client manages to constantly develop further and break new ground.
Compliance Engineer NOVJP (m/f)
Reference: -en
Start: 01/19
Duration: 12 MM++
Main tasks:
- Perform the periodic review of qualified equipment according to the planned intervals and updates the necessary equipment documentation
- Responsible for the service provider qualification; reviews regularly the performed services within the pilot plant and verifies the qualification status / initiates the qualification process for new service providers
- Keep the oversight of all qualified equipment including processes for proper documentation and archiving (life cycle management)
- Prepare / Review GxP documents and forms to be used within assigned projects (Risk Assessments, Q Plans and Reports, Release Sheets, Test Sheets, Project Specific SOPs)
- Prepare / Review commissioning documents and forms to be used within assigned projects (Commissioning Plan, FAT/SAT Protocols, Test Sheets, Handover Sheets)
- Ensure standardization in the qualification/commissioning process over the different projects in the pilot plant
- Support and manages the training process for the engineering and its external partners.
- Execute GMP trainings regarding engineering compliance topics for the engineering team and external partners.
- Perform regular quality reviews of the equipment changes; actively manage the Equipment Change Control process from the initiation to closeout ensuring timely execution of the change control process, e.g. following up pending approvals changes, overdue / open changes
- Prepare GMP Inspections and coordinates follow-ups in the Engineering area
- Implementation of new/revised guidelines (QM, TGD, SOPs, etc.); execution of gap assessments and owner of corresponding actions
- Support Root Cause Analysis for equipment relevant deviations
- Author/reviewer and update of SOPs and FRMs for equipment qualification
Main qualifications
- Degree in mechanical, process or chemical engineering (Dipl. Ing. Or M.Sc. or B.Sc. or equivalent)
- Technical knowhow in pharmaceutical, chemical and/or infrastructure engineering
- Extended interdisciplinary technical knowhow
- Engineering experience in the chemical / pharmaceutical industry
- Very good skills working with MS Office Package, Trackwise skills advantageous
- Knowledge in GMP business (extended Knowledge and understanding of all health authority guidelines and best industry practices)
- Technical knowledge (technical chemical and/or biological knowledge, broad GMP-knowledge, IT-knowledge, continuous improvement)
- Extended knowledge of qualification and validation and equipment
- Fluency in German and English
Main advantages:
- A very renowned company
- You will work in an international 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.
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