Join Our Team as a CQV Specialist (m/w/d)
We are seeking new team members to join us in the pharmaceutical and biotechnology sector in Switzerland. If you are passionate about Validation and Quality Systems, we would love to hear from you.
What We Are Looking For
The Commissioning Qualification Validation (CQV) Specialist will undertake a variety of tasks related to the validation of equipment and facilities. The role involves coordinating the installation of equipment, drafting IQ/OQ/PQ protocols, executing these protocols, and documenting the results according to cGMP requirements.
Key Accountabilities
- Engagement in all validation activities, including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, and Risk Assessment.
- Preparation of validation documentation deliverables such as URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, IOQ, OQ, PQ).
- Execution of IQ/OQ and PQ for equipment, systems, and utilities, alongside writing reports on completed validation activities.
- Identification of efficiencies in the validation program and application of lessons learned while remaining informed of industry regulatory changes related to equipment and facility validation.
- Performance of assigned Quality Systems activities, including Document Management, Change Control, Non-Conformities, and CAPA’s.
- Writing and/or revising procedures related to Engineering activities.
- Supporting the Engineering group in preparing validation, requalification, and maintenance programs.
Your Background and Experience Should Include
- Education Required: Bachelor’s Degree in a Science or Technical field.
- Language: Proficiency in English is required; German is a significant plus.
- Work Experience: 3-6 years in the Pharmaceutical Industry.
- Skills:
- Excellent technical writing skills and the ability to document all work thoroughly, accurately, and in a timely manner.
- Strong written and oral communication skills, with the ability to work interdepartmentally effectively.
- Exceptional organizational and time management skills.
We look forward to receiving your CV. Apply online using the form below. Please note that only applications matching the job profile will be considered.
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