Specialist, Operations Training

Job Summary

The Specialist, Operations Training PO6 provides SOP and process related training to the production department, including performing effectiveness checks, and the incumbent maintains the training records.

Job Responsibilities

• Responsible for executing required cGMP and operational training on all SOPs, equipment and Forms relating to production and plant operations for the Production group.
• Co-ordinates with the Engineering Group to ensure timely and accurate training of operators on the use of new or modified equipment.
• Works closely with the Safety Health and Environment group, to ensure that all our current safety procedures are reflected in departmental SOPs/procedures or SHEIS procedures.
• Provides occasional training on Production equipment/systems/procedures to other departments.
• Attends campaign planning meetings and is responsible for timely execution of required Process (WBR) training.
• Responsible to ensure training "effectiveness checks" have been completed. Reports operational issues when procedures are not being consistently or accurately executed
• Maintain constant communication with Chemical Operators to ensure correct, safe and effective execution of process training elements.
• Reviews and updates training format and scope of training based on observations, requirements and operator feedback.
• Provides support on identification, development and implementation of new technologies/equipment.
• Reviews batch record critical parameters instructions and those related to training items to ensure clarity for production personnel. Looks for process efficiencies and cost saving opportunities. Provides suggestions for improvement to the Process designates.
• Responsible for updating the departmental training database and GMP training binders for designated departments.
• Responsible for maintaining a tracking/monitoring file for production/system compliance deviations triggered by personnel/execution errors. Prepares reports including trending, and participates in deviation investigations.
• Participates in the HAZOP assessment and provides user requirements of new or modified process, operations or equipment.
• Work on projects as assigned by direct Supervisor or management.
• 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
  • Minimum High School Diploma
  • Preference for College Diploma or Chemical Technician (CET) Diploma
• Knowledge, Skills and Abilities
  • Ability to train, organize and plan.
  • Thorough knowledge of cGMPs, SOPs, Forms, Production Equipment as well as safety procedures that apply to the production of active pharmaceutical ingredients (API).
• Experience
  • 5 years experience with a post-secondary diploma; or
  • 10 years experience wth high school education only
  • Experience working a chemical operator is strongly preferred