Beschreibung
For our client in Basel we are looking for Compliance Engineer for a yearly contract.
Duration: to
Location: Basel
Workload: 100%
About the role:
Compliance Engineer ensures that all engineering relevant processes for investment projects and repair & maintenance are fully cGMP compliant and acts as SPOC for GMP issues in technical/engineering topics in the pilot plant.
Major Accountabilities:
- Performs 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.
- Keeps the oversight of all qualified equipment including processes for proper documentation and archiving (life cycle management).
- Prepares/Reviews GxP documents and forms to be used within assigned projects (Risk Assessments, Q Plans and Reports, Release Sheets, Test Sheets, Project Specific SOPs)
- Prepares/Reviews commissioning documents and forms to be used within assigned projects (Commissioning Plan, FAT/SAT Protocols, Test Sheets, Handover Sheets)
- Ensures standardization in the qualification/commissioning process over the different projects in the pilot plant
- Supports and manages the training process for the engineering and its external partners.
- Executes GMP trainings regarding engineering compliance topics for the engineering team and external partners.
- Perform regular quality reviews of the equipment changes; actively manages the Equipment Change Control process from the initiation to closeout ensuring timely execution of the change control process, eg following up pending approvals changes, overdue/open changes.
- Prepares 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.
- Supports Root Cause Analysis for equipment relevant deviations.
- Author/Reviewer and Update of SOPs and FRMs for equipment qualification.
Candidate Profile:
Education: Degree in mechanical, process or chemical engineering (Dipl. Ing. Or M.Sc. or B.Sc. or equivalent).
Languages: Fluent in German and English.
Experience:
- Technical knowhow in pharmaceutical, chemical and/or infrastructure engineering.
- Extended interdisciplinary technical knowhow.
- Engineering experience in the chemical/pharmaceutical industry.
- IT: Experience MS Office Package, Trackwise (advantageous)
Technical/Professional Knowledge and Skills:
- 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).
- Qualification/validation (extended Knowledge in equipment qualification in pharmaceutical industry).
- Interpersonal Skills (good communication skills, coaches and inspires people to achieve team goals; delivers training to maintain state-of-the-art knowledge).
- Safety/Environmental/cGMP (provides pragmatic solutions to ensure compliance with all regulations).
For further details please contact Beata Arciszewska:
email: (see below)
tel: (see below)