
Validation Expert
6 hours ago
As a Quality and Compliance Validation (CQV) expert, you will be responsible for ensuring the quality and compliance of our products and processes.
Key Responsibilities:
- Commissioning Activities:
- Author commissioning protocols for equipment and utilities, including Installation Checks and Functional Testing.
- Participate in and coordinate with engineering & OEMs for Factory Acceptance Tests (FAT)/Site Acceptance Tests (SAT).
- Author DQ, System Impact Assessment, and Risk Assessment documents in coordination with OEMs.
- Qualification and Validation:
- Author, review, and execute qualification protocols for process equipment, including Installation Qualification, Operational Qualification, and Performance Qualification.
- Perform qualification as per regulatory requirements (e.g., FDA, WHO).
- Documentation:
- Maintain sound knowledge of good documentation practices and QMS processes throughout the CQV lifecycle.
- Coordinate with engineering, manufacturing, QA/QC, and IT teams to ensure seamless project execution.
- Provide technical input during project planning and scheduling of CQV activities.
- Track and report progress of CQV milestones.
Required Skills and Qualifications:
- 3-4 years of experience in pharma CQV
- Strong knowledge of GMP regulations and guidelines
- Excellent communication and writing skills
- Project management skills
Benefits:
This role offers an exciting opportunity to work in a dynamic environment, contributing to the development of high-quality products.
About Us:
We are a leading company in the pharmaceutical industry, dedicated to delivering innovative solutions that meet the highest standards of quality and compliance.
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