CQV Specialist I

AtomVie Global Radiopharma•Hamilton, ON

8d•Onsite

About The Position

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. About The Role Reporting to the Engineering Manager as a CQV Specialist, assist the Engineering department focused on laboratory equipment qualifications, calibrations, recertifications, and documentation execution in compliance with GMP practices. This role will also coordinate third-party contractors and contribute to the continuous improvement of the engineering department. . Location: AtomVie Global Radiopharma Inc, Hamilton ON (Onsite).

Requirements

A minimum of a College Diploma in a technical field (Metrology, Pharmaceutical Sciences etc.,) or relevant experience.
Minimum of 2-5 years hands on working experience in GMP Pharmaceutical lab setting preferably the Metrology role.
Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.

Nice To Haves

Sound knowledge of authority regulations like Health Canada and FDA etc.
Excellent knowledge of operating Empower CDS and operating and troubleshooting on Waters HPLC systems.
Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot.
Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.

Responsibilities

Manage and execute vendor and internal calibration & preventive maintenance 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
Perform equipment qualification and validation activities across AtomVie. Such as executing HPLC annual qualifications, Gas Chromatography equipment qualification and balances performance verification and annual calibration etc.
Create/Develop the lab instrument operational SOP and maintenance programs in CMMS.
Lead/Support the development and execution of all qualification documentation related to laboratory equipment and software validation.
Collaborate across teams and locations to ensure calibration programs are implemented and maintained in accordance with cGMPs and the Validation Plan.
Investigate and troubleshoot problems relating to any CQV tasks. Provide technical assistance during investigations of equipment and validation issues, aid in the resolution of qualification/validation deviations and protocol discrepancies.
Lead/Support non-conformances related to deviations occurring when equipment fails to meet acceptance criteria
Assist or lead the troubleshooting and repair of production and QC related equipment as needed
Co-ordinate with the direct supervisor and technicians to ensure management and QA are informed of compliance status and adherence to commitments.
Lead and author nonconformance reports, change controls, and CAPAs, ensuring follow-through to completion within the proposed timeline.