Coordinator, Validation Support

Job Summary

Responsible for coordination and execution of validation activities within the Manufacturing Science & Technologies (MST) Department. This role has individual responsibility for coordination and execution of process and cleaning validation related project deliverables (e.g. protocol creation and execution, data analysis, reporting). 

Acts as a resource with process and cleaning validation knowledge pertaining to manufacturing, filling/packaging processes 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 cleaning 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 process and cleaning Validation protocols.
• Provides training on process and cleaning 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. Performs peer review of process and cleaning 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 processes and cleaning validation.
• 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. Support investigations by assembling and coordinating cross-functional teams to determine root cause and corrective actions for unacceptable process and cleaning validation results.
• Provides technical assistance related to process or cleaning validation to customers and various departments and divisions within Apotex.
• Operates and maintains validation equipment/instruments and consumables.
• 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.
• 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 Behaviors 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’s degree in science or engineering, or equivalent experience.
• Knowledge, Skills and Abilities
• High level of familiarity with Excel, Word, LIMs, PACE.
• 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 process or cleaning 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 processes for liquid dose products (sterile ophthalmic and nasals products) is an asset.