Validation Specialist

5 months ago

Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

**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**

The Validation Specialist supports compliance with Good Manufacturing Practices (GMP) in relation to validation and qualification activities. These activities are performed in support of the production of both clinical and commercial products, from the introduction of new programs to the routine manufacturing phase at AtomVie facilities.

**What You Will Do**
- Provides quality oversight of validation and qualification activities.
- Ensures that GMP guidelines, company’s policies and procedures are followed in relation to validation and qualification activities.
- Helps maintaining the Company Validation Master Plan and ensures that it remains in compliance with regulatory requirements and company’s policies and procedures.
- Ensures that validation and qualification 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.
- Reviews and approves records associated to the validation, qualification, and calibration programs (e.g., protocols, specifications, scripts, reports, risk assessments, certificates, non-conformances, change control, etc.).
- Ensures a risk-based methodology is applied to GxP validation activities as per company’s guidelines.
- Ensures quality management is informed of validation activities status and adherence to commitments.
- Participates in continuous improvement initiatives.
- Participates in quality investigations and non-conformances documentation.
- Coordinates activities with affected departments and project team members.
- Establishes strong relationships inter
- and intra-departmentally.
- Serves as the Quality Assurance representative on cross-functional teams to support transition of manufacturing processes from validation to routine production.
- Works closely with other departmental managers to ensure employees are working in compliance with internal policies and procedures, external client expectations, and GMPs.
- Communicates quality and compliance issues to all relevant stakeholders in a timely manner.
- Ensures AtomVie is inspection ready and is operating within a compliant quality environment.
- Completes all other duties as assigned.

**What You Bring to the Role**
- Excellent technical report writing skills, ability to understand and analyze technical systems.
- Exposure to computer systems validation preferably in the pharmaceutical industry in the areas of Quality, IT, and Manufacturing.
- Knowledgeable in GxP, GDP, GAMP, 21CFR Part 11, and industry best practices.
- Attention to detail, highly organized, critical thinking, strong problem solving, interpersonal and verbal skills.
- Ability to develop and maintain relationships with internal and external business partners.
- Knowledgeable of the processes and controls applied in the radiopharmaceutical industry.
- Ability to adjust work schedule based on business requirements.

**Requirements**:

- Bachelor’s degree in sciences, engineering, or equivalent preferred.
- 3 to 5 years of direct experience in pharma/biotech manufacturing, and quality environments/organizations.
- 3 years of direct experience in validation/qualification.

**AtomVie Offers**
- Group Health & Dental Benefits (from day 1)
- RRSP Matching
- Perkopolis
- Employee Assistance and Wellness Programs
- Parking Allowance

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