Job Description

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor 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

The Validation Specialist provides quality oversight of Facility, Utility, Equipment validation, qualification, and maintenance activities. The Validation Specialist also authors and executes computer validation / qualification protocols and supports process validation activities.

The position ensures that GMP guidelines, company’s policies and procedures are followed in relation to validation / qualification protocol execution, and maintenance activities.

What You Will Do

• Provides quality oversight of facility, utility and equipment commissioning, qualification and maintenance activities.
• Preparation and execution of computer validation / qualification protocols, reports and related non-conformances, CAPAs and Change Controls.
• Support process validation and related activities for investigational and commercial products and processes, including: Aseptic process qualification, Process qualification/validation, Airflow visualization (smoke study), Cleaning validation/verification, Shipping / transportation qualification and Validation/qualification related to non-conformances, change controls and CAPAs.
• Author and revise AtomVie SOPs, work instructions, forms and policies.
• Ensures that GMP guidelines, company’s policies and procedures are followed in relation to validation / qualification protocol execution, and maintenance activities.
• Oversee assigned projects and when required execute project deliverables to ensure that high quality standards are met within the projected timelines and project outcomes are compliant with internal/external requirements and GMP regulations.
• Help maintaining the Validation Master Plan and ensure that it remains in compliance with regulatory requirements and Company’s policies and procedures.
• Ensure that validation, qualification and maintenance activities are documented as per GMP guidelines, company’s policies and procedures.
• Supports protocol execution activities, in collaboration with area SMEs.
• Supports the preparation of protocols, reports, non-conformances, and other quality documents.
• Participate in continuous improvement initiatives.
• Participate in quality investigations and non-conformances documentation.
• Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
• Complete other duties as assigned.

What You Bring to the Role

• Proficiency in the English language both written and oral, and excellent communication skills; detail-oriented
• Ability to work independently and possess excellent organizational skills
• Strong communication and teamwork skills

Requirements

• 3 to 5 years of relevant experience, with direct facility/utility/equipment qualification, computer validation and / or aseptic qualification experience preferred
• Experience working in a GMP environment is required
• Experience preparing / executing validation and qualification protocols is required, with Computer Validation experience preferred.
• Training and experience in quality systems, quality audits, good documentation practices, change controls, CAPAs and review of quality records
• Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of the regulations as they pertain to sterile products

AtomVie Offers

• Group Health & Dental Benefits (from day 1)
• RRSP Matching Program
• Perkopolis
• Employee Assistance and Wellness Programs
• Parking Allowance

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.

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