Lead Executive, MS&T - CPV

Job Summary

• Responsible for preparation and coordination of Process Validation-Stage 3 (CPV) studies, in accordance with FDA, HPFBI, EC, and ICH’s guidelines and applicable Apotex policies and processes.

Job Responsibilities

• Creates protocol/reports and other documentation related to CPV Stage 3B, in PACE and other systems.
• Collects data from SAP and LIMS and other quality system to compile reports, performs statistical analysis and evaluations, as required and ensures that CPV reports follows Apotex procedures and policies.
• Creates and reviews projects in PACE and ensures completion of all actions in PACE (e.g. validation history, batch planning), as applicable.
• Monitors and assesses Stage 3B trending of products as required.
• Coordinates and executes all related activities with cross-functional teams for timely escalation and closure of reports.
• Supports CPV management in achieving departmental goals.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensures personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, policies and procedures, Safety and Environment policies, and HR policies.
• Works with the Supervisor, assists in coordinating the training of new employees.

All other relevant duties as assigned

Job Requirements

• Education
  • Degree, Diploma or Certification in Chemistry, Pharmaceutical Technology, Pharmacy or related science
• Knowledge, Skills and Abilities:
  • 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.
  • High level of familiarity with Excel, Word, PowerPoint and statistical tools required.
  • Excellent English oral and written communication skills.
  • Knowledge of validation concepts and regulatory guidances (e.g. PV guidance, ICH 8, 9, 10, 12) is an asset
  • Ability to be flexible and multi-task in a rapidly changing environment.
• Experience
  • Minimum 8-10year of experience in the pharmaceutical industry.