What are the responsibilities and job description for the C&Q Engineer position at ProQualityNetwork?
Job Description
Job Description
Job Title : Commissioning and Qualification (C&Q) Specialist Pharmaceutical Manufacturing
Location : North Carolina (Open to U.S. citizens, preferably local residents)
Employment Type : Contract
ProQuality Network is seeking a highly motivated and detail-oriented C&Q Specialist to join our team and support our client's mission to deliver excellence in pharmaceutical manufacturing.
Job Description :
The Commissioning and Qualification (C&Q) Specialist will play a key role in ensuring that equipment, utilities, and facilities meet regulatory and operational requirements. This position involves writing, reviewing, and executing qualification protocols and reports while working closely with cross-functional teams in a fast-paced environment.
Key Responsibilities :
- Develop, review, and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure compliance with FDA, cGMP, and other applicable regulatory standards during C&Q activities.
- Conduct system walk-downs, inspections, and testing to confirm system functionality and readiness for use.
- Identify and resolve discrepancies or non-conformances in qualification activities.
- Prepare detailed qualification summary reports, including deviations and resolutions.
- Collaborate with project managers, engineers, and quality assurance teams to ensure seamless execution of C&Q activities.
- Support risk assessments and validation planning for new and existing systems.
- Maintain accurate and organized documentation to ensure traceability and compliance.
Qualifications :
Preferred Qualifications :
