Location: Solothurn, Switzerland
Start: January 2019
Duration: 6 Months +
Key Responsibilities and Deliverables:
* Commissioning execution and approval. Includes vendor supervision on their testing scope and quality.
* Installation and Operational Qualification execution and approval. Includes vendor supervision on their testing scope and quality.
* Creation and approval of Commissioning and qualification reports.
* Support with resolving any deficiencies and deviations that may occur during commissioning and qualification.
* Update of User Requirement Specifications and other design documents to as-built state if required after commissioning & qualification.
* Ongoing support for assigned systems, including follow-up with vendors if necessary until handover of systems to the User.
* Background in either engineering or related scientific area
* Several years of experience in qualification / commissioning of manufacturing plants in GMP area
* Fluent English language written and verbal communication skills, German is a plus
* GMP knowledge and knowledge of EMA and FDA predicate rules
* Able to work with minimum oversight fulfilling deliverables within target dates
If you`re interested in this Job-Opportunity, please contact me.
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