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CQV (Utilities & Facilities) Consultant
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CQV (Utilities & Facilities) Consultant
EFOR3-5 Years
- Posted 21 hours ago
- Be among the first 10 applicants
Job Description
As part of our company's growth, we are seeking an experienced Qualification & Validation Pharmacist to join our team. You will be responsible for:
- Lead and execute commissioning, qualification, and validation (CQV) activities for utilities and facilities (HVAC, water systems, steam, compressed air, etc.).
- Develop and review Qualification protocols (DQ, IQ, OQ, PQ) for utility and facility systems.
- Prepare, execute, and document qualification tests and reports for utilities and facilities.
- Ensure compliance with GMP, FDA, EMA, and relevant industry standards and guidelines.
- Collaborate closely with engineering, QA, and operations teams to support project delivery.
- Identify and resolve technical issues during commissioning and qualification.
- Review and approve technical documentation (URS, SOPs, design documents).
- Participate in risk assessments and change control processes as required.
- Provide technical expertise during audits and inspections.
- Support training of site staff on qualified systems and procedures.
Please note that this list is not exhaustive and may evolve depending on the needs of the role.
Profile Sought:
- Proven experience (3+ years) in CQV for pharmaceutical utilities & facilities.
- In-depth understanding of GMP, validation processes, and regulatory requirements.
- Strong knowledge of utility systems (HVAC, clean/pure water, steam, compressed gases, waste systems).
- Hands-on experience with commissioning and qualification documentation and execution.
- Excellent communication and interpersonal skills.
- Ability to work both independently and in cross-functional teams.
- Strong analytical, troubleshooting, and problem-solving skills.
- English fluency (written and spoken); other languages are an advantage
