Coordinator, Validation Support

Job Summary

Responsible for coordination and execution of validation activities within the QA Validation & Engineering Department. This role has individual responsibility for coordination and execution of validation related project deliverables (e.g. protocol creation and execution, data analysis, reporting) with respect to equipment, process, and sterile/aseptic Performance Qualification (e.g. airflow assessments, VHP, moist heat validation, process validation).

Acts as a resource with process validation and production systems knowledge pertaining to filling/packaging and sterilization processes installed at the site. Provides support to investigations and development of study protocols as required.

Job Responsibilities

• Writes, reviews, and, where applicable, executes all validation risk assessments, validation protocols, and validation reports related to process and sterilization validation. In developing these protocols, the parameters of the study and the sampling and testing criteria are designed for worldwide regulatory compliance (FDA, HPFBI, EC and ICH standards).
• Coordinates execution, analyses data, and summarizes results for Sterilization Validation protocols.
• Provides training on validation topics as required to Validation Team Members, and potentially to outside departments and organizations.
• Performs technical review of commissioning/validation protocols prepared by Engineering, and Equipment & Facilities Qualification team members. Performs peer review of validation documentation for errors/omissions, comprehension and compliance with cGMP and SOPs.
• Reviews, initiates and recommends changes to SODs, and Production master documents. Reviews the impact of proposed changes to Production master documents and SODs via CCR and investigations with respect to the validation status of products and/or processes
• Communicates and escalates validation deviations in a timely manner. Provides troubleshooting assistance and suggest remedial and corrective actions in the case of unacceptable validation results. Leads investigations by assembling and coordinating cross-functional teams to determine root cause and corrective actions for unacceptable validation results.
• Provides technical assistance related to validation to customers and various departments and divisions within Apotex. May sit on necessary project teams as required.
• Operates and maintains validation equipment/instruments and consumables.
• Assists in calibration and calibrates validation equipment/instruments as required.
• Communicate with equipment/consumables suppliers to obtain required technical information.
• Ensures that procedures, work instructions and master documents describe critical parameters or ranges determined in the validation reports (if applicable).
• Communicates project status updates to management through the use of tracking sheets (Excel or MS Project).
• Works alternate hours/shift schedules due to planned business needs.
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
• Works as a member of a team to achieve all outcomes;
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor degree in Science or Engineering, or equivalent experience.
• Knowledge, Skills and Abilities
  • High level of familiarity with Excel, Word, Access required.
  • Proven organizational, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast-paced environment.
  • Excellent English oral and written communication skills.
  • Strong interpersonal skills
• Experience
  • Minimum of three to five years in Validation. Experience in sterilization validation, equipment/process qualification is an asset.
  • Experience in the pharmaceutical, food, or other chemical processing industry, ideally with exposure to compounding, filling/packaging and cleaning/sterilization processes for liquid dose products (sterile ophthalmic and nasals products) is an asset.