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Validation Specialist

Centre for Probe Development and Commercialization

This is a Contract position in Vancouver, ia posted September 14, 2021.

Company Profile: Since 2008, the Centre for Probe Development and Commercialization (CPDC) has collaborated with industry and academic partners to discover, develop, and distribute next-generation radiopharmaceuticals used in early detection and treatment of human diseases such as cancer.

The CPDC is recognized as a leading radiopharmaceutical organization with a full range of scientific, technical, regulatory, and business expertise required to translate radiopharmaceuticals to the clinic and provide them to the commercial marketplace across North America and Europe.

Situated on the McMaster University Main Campus in Hamilton, the CPDC is a growing organization seeking a GxP Validation Expert reporting to the VP of Quality Operations.

Benefits of working at CPDC: Opportunity to work for a leading organization in a niche industry devoted to detection and treatment of diseases such as cancer Competitive compensation and benefits package Paid sick days Medical/Dental Appointment time off Training and Professional Development support Position Title
– Supervisor, Validation Program This position will be based in Hamilton, Ontario, Canada.

Reporting to the Vice President; Quality Operations Duties/Responsibilities include but are not limited to: Establish policies, guidelines, and procedures for the performance of validation, qualification, and calibration activities, in compliance with GxPs.

Own and maintain the Company Validation Master Plan and ensure that it remains in compliance with regulatory requirements and Company’s policies and procedures.

Act as subject matter expert and represent Quality Operations, ensuring responsible areas maintain compliance with GMPs and the CPDC Validation Master Plan.

Provide input in planning, compliance risk, and impact to quality in regards to validation, qualification, and calibration activities.

Support protocol execution activities, in collaboration with area SMEs.

Support the preparation of protocols, reports, non-conformances, and other quality documents.

Supervise, set goals and priorities for the validation service contractors.

Ensure that Manufacturing and Quality Operations are informed of compliance status and adherence to commitments.

Review and approve records associated to the validation, qualification and calibration programs (e.g., protocols, specifications, scripts, reports, risk assessments, certificates, non-conformances, change control, etc.) Ensure a risk based methodology is applied to GxP validation activities as per CPDC’s guidelines.

Proactively assess processes with the intend of building improvements and reduce complexity Participate in continuous improvement initiatives.

Participate in quality investigations and non-conformances documentation.

Coordinate activities with affected departments and project team members Provide leadership and guidance as it relates to the programs of validation, qualification and calibration.

Ensure compliance with Health and Safety, engaging all associates to comply with the policies, procedures and regulations applicable to their job.

All other duties as assigned.

Requirements: Proficiency in the English language both written and oral.

Excellent communication skills.

Detail-oriented and teamwork skills.

Ability to work independently and possess excellent organizational skills.

Leadership capability (i.e.

takes initiative to lead self and others, to lead by example and follow through to completion often with minimal direction).

Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.

Proficient in a variety of software applications (e.g., Microsoft Word, Excel, PowerPoint, Project, Visio, etc.).

Ability to operate with little supervision and handle simultaneous priorities in a fast paced environment.

Strong project management skills with the ability to work independently and within a team.

Good project management skills.

Knowledgeable in GxP, GDP, GAMP, 21CFR Part 11, and industry best practices.

Knowledgeable of the processes and controls applied in the radiopharmaceutical industry.

Ability to adjust work schedule based on business requirements.

Required Education/ Experience: Masters or Bachelor’s degree in Science, engineering, or equivalent degree.

5
– 10 years of direct experience in pharma/biotech manufacturing, and quality environments/organizations.

Minimum 3-5 years of direct experience in managing and driving validation/qualification projects.

Experienced in computer systems validation in the Pharmaceutical industry in the areas of Quality, IT, and Manufacturing.

If you require accommodation for your application or interview, please contact Human Resources at 905 525-9140 ext.

21112 or by email at careersimagingprobes.ca We thank all applicants but only candidates selected for interviews will be contacted.