Requirements: English
Company: CTC Resourcing Solutions
Region: wallis, switzerland , Wallis
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CQV Specialist 6073
JP00004404
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CQV Specialist to be based in the Valais area, Switzerland.
This is an initial contract ideally starting September 2024 until March 2025 with extension already planned.
The Commissioning Qualification Validation engineer carries out a variety of tasks related to the validation of equipment and facilities. The scope of activities includes the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according to cGMP requirements.
Responsibilities:
- Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
- The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
- Prepare validation documents.
- Execution of IQ/OQ and PQ for equipment, systems and utilities.
- Write reports of completed validation activities.
- Work to identify efficiencies in the validation program approach.
- Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment/facility validation.
- Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPAs.
- Writing and/or revising procedures applicable to the Engineering activities.
- Support the Engineering group to prepare the validation, requalification, and maintenance program.
- Perform other duties as assigned.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- Bachelors Degree in Science or Technical field.
- Minimum 3 years experience in Pharma Industry.
- Fluent in English is a must, German is a plus.
- Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
- Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
- Excellent organizational and time management skills.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the ''apply now'' button, or write an email to us, or reach out to us on the phone.
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