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About the Role

The Validation Coordinator implements the validation strategy, executes activities, and completes milestones for validation/qualification projects. This role supports ongoing validation efforts and quality systems for drug product manufacturing and testing, contributing to validation strategies and risk management assessments.

Responsibilities

• Perform commissioning and qualification of new and existing production equipment and instruments, including major capital projects.
• Maintain and enhance validation programs for existing equipment and utility commissioning/qualification.
• Participate in the optimization of existing process validation procedures and technical transfer activities.
• Assist in the development of a process validation program.
• Draft, review, execute, and approve protocols and reports related to equipment, facility, and process validation, including deviation reporting.
• Act as Quality contact and primary Subject Matter Expert (SME) for Validation and Quality Risk Management.
• Evaluate and update the Validation Master Plan to ensure alignment with corporate policies and industry standards.
• Provide guidance and lead Validation Associates and Assistants.
• Participate in regulatory audits and respond to audit observations and corrective actions.
• Analyze and implement improvement opportunities for quality systems, validation processes, and technical transfer procedures.
• Support current industry practices for CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
• Collaborate with cross-functional groups, including Quality, Manufacturing, Process Development, Engineering, and Regulatory Affairs.
• File and maintain controlled documents.
• Provide technical assistance and training for personnel.
• Maintain a working knowledge of current GMP, ICH, Health Canada, and FDA guidelines and regulations.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, Chemistry, Microbiology, or a related field.
• Minimum 3–5 years of experience in Validation, Quality Assurance, and Quality Control within pharmaceutical or biopharmaceutical manufacturing environments.
• Working knowledge of cGMP, GDP, ICH, Health Canada, FDA, and other applicable regulatory requirements.
• Experience with equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, utility qualification, and computerized systems validation is considered an asset.
• Experience working in regulated manufacturing settings with a focus on quality and compliance.
• Ability to interpret and apply regulatory standards and industry best practices.

Experience Level

• 3-5 years

Education Level

• Bachelor's degree

Benefits

• Gym Access
• Dental insurance
• Health insurance

About the Company

• Apollo Health & Beauty Care Ltd. will ensure accommodations are available in consultation with candidates during all stages of the recruitment process.
• Apollo is committed to providing accommodations for people with disabilities in all parts of the hiring process.
• Apollo will work with applicants to meet accommodation needs that are made known in advance.
• We thank all applicants for their interest however only those meeting the minimum qualifications will be interviewed.
• Vacancy Status: This posting represents an existing vacancy, and we are actively recruiting to fill this position.

Equal Opportunity

• Apollo Health & Beauty Care Ltd. will ensure accommodations are available in consultation with candidates during all stages of the recruitment process.
• Apollo is committed to providing accommodations for people with disabilities in all parts of the hiring process.
• Apollo will work with applicants to meet accommodation needs that are made known in advance.