09 Aug
|
IncepBio
|
Bengaluru
09 Aug
IncepBio
Bengaluru
Role And Responsibilities
- Develop and implement commissioning, qualification, and validation strategies in compliance with regulatory requirements and industry best practices.
- Collaborate with cross-functional teams, including engineering, quality assurance, manufacturing, and regulatory affairs, to ensure smooth and timely execution of CQV activities.
- Plan, schedule, and coordinate commissioning, qualification, and validation activities for current equipment, systems, and processes.
- Design and review protocols, test plans, and documentation for commissioning, qualification, and validation activities.
- Perform risk assessments and gap analyses to identify potential issues and develop mitigation strategies.
- Lead and manage a team of CQV professionals, providing guidance, training, and performance feedback.
- Monitor and evaluate the progress of CQV activities, ensuring adherence to project timelines and deliverables.
- Collaborate with external vendors and contractors to ensure the successful completion of commissioning, qualification, and validation projects.
- Review and approve CQV documentation, reports, and deviations, ensuring accuracy, completeness, and compliance.
- Participate in regulatory inspections and audits, providing necessary documentation and support.
- Provide support the cross functional team internally for document/report preparation and review.
📌 Commissioning Qualification Validation (Bengaluru)
🏢 IncepBio
📍 Bengaluru