Commissioning & Qualification Engineer
Commissioning & Qualification Engineer
Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.
For one of our clients specialized in the pharmaceutical area, we are looking for an experienced Commissioning & Qualification Engineer with proven experience in a pharma company.
This is a 5 Months contracting position starting in July with extension possibilities.
Responsibilities:
- In charge of commissioning and qualification (C&Q) activities for Technical Services department in order to ensure that: - Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities - Qualification/Validation Master plans are up to date and established for all ongoing projects in QC
- Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners
- Coordination and oversight of external suppliers
- Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics
Must Haves:
- Bachelor/Master Degree in technical or natural sciences
- minimum of 3 years of working experience within pharma company in C&Q equivalent position
- Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
- Know-how of quality assurance principles and experience working with cross-department stakeholders
- Know-how of ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Strong communication skills in English
- German language is a plus
- Self time management
Location: Bern
Start Date: 05/07/2021
End date: 31/12/2021
Workload: 100%
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