Description
Compliance Engineer wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- University degree in Mechanical, Chemical or Process Engineering with experience in the chemical or pharmaceutical industry
- Technical knowhow in Pharmaceutical, Chemical or Infrastructure Engineering and extended interdisciplinary technical knowledge
- Confidence in GMP business, including health authority guidelines and best industry practices along with proficiency in equipment qualification in pharmaceutical industry
- Familiarity with MS Office Package, Trackwise is an advantage
- Ability to coach and train the team to achieve team goals as well as to maintain state-of-the-art knowledge
- Languages: fluent English and German both written and spoken
Your tasks:
- Ensuring periodic review of qualified equipment including processes for proper documentation and archiving (life cycle management) and updating the necessary equipment documentation
- Being responsible for the service provider qualification, inclusive regularly review of the performed services within the pilot plant as well as initiation of the qualification process for new service providers
- Preparing GxP documents, consisting of Risk Assessments, Release Sheets, Test Sheets and Project Specific SOPs as well as commissioning documents, including Commissioning Plan and FAT/SAT Protocols for assigned projects
- Providing GMP trainings regarding engineering compliance topics for the engineering team and external partners as well as implementing of new or revised guidelines, such as QM, TGD and SOPs
- Performing regular quality reviews of the equipment changes along with preparing GMP Inspections and coordinating follow-ups in the Engineering area
Start:
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH13861
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more