Commissioning & Qualification Engineer

Sector:
Pharmaceutical
Location:
Switzerland
Sub-location:
Any
Currency:
CHF
Job Type:
Any
Salary:
100 per hour
Posted:
07/04/2021
Ref No:
CR/105329

Working for a Medical Device client in Switzerland

Job title: Commissioning & Qualification Engineer

Professional background

• 5 years working experience within pharmaceuticals, biotechnologies or chemical industry

• Know-how of commissioning and qualification requirements according to (c)GMP regulations

• 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

• 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

• Fluent English & Conversational German required

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

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