CQV Consultant (Pharmaceutical Manufacturing)
3 days ago
CQV Consultant (Pharmaceutical Manufacturing)
Role Overview:
Join our team to provide risk-based commissioning, qualification, and validation (CQV) se..
CQV Consultant (Pharmaceutical Manufacturing)
Role Overview:
Join our team to provide risk-based commissioning, qualification, and validation (CQV) services to pharmaceutical and biopharmaceutical clients. You will contribute to process improvements, ensure compliance with regulatory standards, and address challenges in manufacturing and quality operations.
Key Responsibilities:
CQV Services:
- Execute risk-based CQV for process equipment, CIP/SIP, utilities, enterprise systems (e.g., LIMS, QMS), and analytical methods.
- Develop science-based validation protocols aligned with industry best practices.
Documentation & Reporting:
- Prepare risk assessments, protocols, and reports for CQV activities.
- Analyze performance data and deliver insights to stakeholders.
Problem-Solving:
- Investigate deviations, identify root causes, and recommend corrective actions.
- Apply regulatory and industry guidelines to ensure compliant solutions.
Qualifications:
- Please note that this role is for a Consulting firm.
- Bachelor’s degree in Engineering, Science, or related field (or equivalent experience).
- 3+ years in pharmaceutical CQV, quality systems, or technology transfer.
- Knowledge of ICH, ISO, and regulatory standards preferred.
- Expertise in multiple CQV disciplines (e.g., CIP/SIP, lab systems) is an advantage.
- Candidates from QC background can apply this role, please indicate your relevent experiences.
Specialized Skills (Preferred):
- Aseptic techniques, LIMS qualification, or test method validation.
- Familiarity with Validation Lifecycle and regulatory agency interactions.
License No: 23S1595
Registration No: R23116355
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