CQ Manager

No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.

We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development. 

By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.

Scope and Responsibilities:

• Coordinates and Supervises all C&Q activities related to the project, managing the project C&Q resources
• Liaise with the various stakeholders on the Project C&Q team and the overall project
• Approves C&Q planning documents detailing overall strategy for the project
• Develops and approves the master list of C&Q test documents and activities
• Reviews and Approves C&Q summary reports
• Ensures the C&Q schedule is developed and maintained
• Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned
• Pre-Approval and Post approval of C&Q test documents.
• Manages Daily C&Q coordination meetings.
• Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
• Ensures Startup of equipment/utilities is completed in a safe and coordinated manner
• Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
• Participation in C&Q activities
• Review and Input into technical requirement specifications and vendor turnover documentation.
• Review and/or author C&Q deliverables e.g. System classification, System Boundary Drawings, Requirement Traceability Matrix
• Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates

Qualifications:

• BS Engineering (or equivalent experience)
• 10 years CQ experience in pharmaceuticals or biologics.
• In-depth equipment commissioning and startup knowledge and experience with strong troubleshooting skills.
• Demonstrated people management skills.
• GMP knowledge is required as Installation and Operational Qualification execution is included in the role.
• Familiarity with quality standards and processes to follow federal, state and local regulations
• Communication skills to convey information in reports, meetings and status reports
• Knowledge of the product to perform accurate quality control
• Attention to detail
• Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions to those flaws
• Interpersonal skills
• Ability to handle stress
• Ability to operate under deadlines while still meeting standards

EA License No: 19C9587