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Commissioning, Qualification
2 weeks ago
As a CQV Engineer, you will be responsible for ensuring the successful commissioning, qualification, and validation of equipment, systems, and processes within client's pharmaceutical plant. You will play a crucial role in maintaining compliance with industry regulations, optimizing operational efficiency, and ensuring the quality and safety of the products.
Responsibilities
- Commissioning: Oversee the commissioning activities for new and existing equipment and systems. Develop and execute commissioning plans, protocols, and reports. Coordinate with cross-functional teams to ensure smooth equipment startup and integration.
- Qualification: Lead the qualification efforts for equipment, utilities, and facilities. Develop and implement qualification protocols (IQ, OQ, PQ) in accordance with regulatory requirements and industry best practices. Conduct risk assessments and ensure proper documentation of qualification activities.
- Validation: Manage the validation processes for manufacturing processes, cleaning procedures, and computer systems. Create and execute validation plans, protocols, and reports. Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
- Documentation: Maintain comprehensive and accurate documentation of commissioning, qualification, and validation activities. Ensure all documentation meets regulatory standards and is audit-ready.
- Compliance: Stay updated on industry regulations and guidelines related to CQV. Ensure all activities are performed in compliance with regulatory requirements (e.g., FDA, EMA) and internal quality standards.
- Continuous Improvement: Identify opportunities for process improvements and efficiency enhancements. Collaborate with cross-functional teams to implement best practices and drive continuous improvement initiatives.
- Training and Support: Provide training and support to plant personnel on CQV procedures and requirements. Assist in troubleshooting and resolving CQV-related issues.
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Certification in CQV or related areas, will be added advantage.
- Strong knowledge of GMP, FDA, and EMA regulations, and experience in regulatory inspections and audits.
- Proficiency in using validation software and tools.
- Minimum 5 years of experience in commissioning, qualification, and validation within the pharmaceutical industry.
- Experience with risk assessments, validation protocols (IQ, OQ, PQ), and technical writing.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Attention to detail and commitment to quality.
