CQV Supervisor

at  AtomVie Global Radiopharma Inc

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

REQUIREMENTS

• A minimum of a College Diploma/degree in a technical field (Engineering, Metrology, etc.,) or relevant experience.
• Minimum Five plus (5+) years of qualification and validation experience in a pharmaceutical GMP environment.
• Experience with managing a team.
• 5 years of demonstrated leadership and behavioral competencies.
• Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of regulations as they pertain to sterile products is preferred
• Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot.
• Flexibility and willingness to work weekends, holidays and support on-call 24/7 (rotating schedule).
• Willingness to work fluctuating start times to meet business needs.
• Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.

ABOUT THE ROLE

Reporting to the Engineering Manager – Facilities & Maintenance, the CQV Supervisor will lead and support the execution of all CQV activities in alignment AtomVie’s QMS requirements and GMP regulations. This role will manage a CQV team and third-party contractors, contributing to the continuous improvement of the engineering department.

WHAT YOU WILL DO

• Overall accountability for company equipment and facilities to ensure AtomVie systems are kept current to new regulatory trends and industry standards.
• Develop commissioning, qualification, and validation documents related to Temperature Mapping & smoke studies and IQ,OQ,PQ protocols for equipment, facilities, and software validation.
• Perform equipment qualification and validation activities for Grade A Hot cell, BSCs, Isolators and Controlled Temperature Units, cleanrooms, material storage areas etc.
• Develop, manage and execute vendor calibration programs, including the review and approval of service records and reports (e.g., calibration certificates, completed protocols, work orders, and vendor reports) to ensure completeness and accuracy
• Collaborate across teams to ensure calibration programs are implemented and maintained in accordance with cGMPs and AtomVie’s QMS.
• Develop work plans, assign tasks within CQV team, and follow through to completion.
• Co-ordinate with the production and other teams to ensure that calibration and qualification activities do not impact their schedules.
• Investigate deviations, nonconformance (NC) and troubleshoot problems relating to any CQV tasks. Provide technical assistance during investigations of equipment and validation issues, aid in the resolution of validation deviations and protocol discrepancies.
• Lead or participate in risk assessments and gap analysis. Initiate Change Controls (CC) or Implement Corrective Action Preventative Action (CAPA) accordingly.
• Review and analyze equipment and facilities performance; recommend, plan, and implement improvements that will increase efficiencies, performance, and reliability.
• Lead regulatory audits as the CQV’s team SME. Present and defend validation studies during regulatory, partner and internal inspections.
• Ensure Health and Safety compliance, engaging all associates to comply with the policies, procedures, and regulations applicable to their job.
• Communicates compliance issues to all relevant stakeholders in a timely manner.
• Participate in trainings, as deemed necessary for the role.
• Complete all other duties as required.

WHAT YOU BRING TO THE ROLE

• Passion for driving continuous improvements in processes, efficiency, and overall performance through innovative solutions and data-driven strategies
• Solid understanding of cGMP validation requirements / guidelines and current industry practice.
• Thrives in a fast-paced setting
• Experience in building and developing a CQV Team.
• Ability to work independently and possess excellent organizational skills.
• Highly motivated with strong attention to detail