Associate, MTS-Cleaning Validation

Responsible for planning and executing cleaning validation activities in accordance with FDA, HPFBI, EMA, and ICH’s guidelines and applicable Apotex policies and processes.

• Liaises with key business members to generate CV Product and SOD Risk Assessment reports, when evaluating new and/or changes to product formulations and equipment cleaning procedures to assess if Cleaning Validation Protocol studies are required.
• Generates Cleaning Validation protocols/studies. In developing these studies, sampling requirements and acceptance criteria are selected to represent worst-case conditions and the sampling and testing criteria are designed for world-wide regulatory compliance (FDA, HPFBI, EC and ICH standards).
• Co-ordinates the cleaning validation event activities (sampling, cleaning, testing requests) with the assistance of production/packaging as required.
• Executes cleaning validation/verification events:
  • LIMS project generation and sampling preparation,
  • Perform visual inspection and sampling of equipment,
  • Delivers samples to the laboratory,
  • Perform Viewing of cleaning execution, and
  • Complete LIMS and/or visual inspection form result entry and electronic filing of completed results.

• Reviews lab results for compliance to validation protocol acceptance criteria, updates the appropriate tracking and filing systems, and communicates results for equipment release.
• As necessary, evaluates, maintains and orders sampling supplies.
• Provides coaching to technicians and operators involved in cleaning validation activities.
• Provides technical assistance, in conjunction with the management team, related to validation to outside suppliers and various departments and divisions within Apotex. May sit on necessary project teams as required.
• Communicates project status updates to management through the use of tracking sheets (Excel or MS Project).
• Performs other related duties as assigned.

• Education
  • Bachelor’s degree in Science or Engineering

• Knowledge, Skills and Abilities
  • Proven organizational, risk management, 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 are a must. Strong technical writing skills are required.
  • High level of familiarity with Microsoft Office (Excel, Word) is required. LIMS experience is an asset.
  • Must be able to excel both within a team environment and independently.
• Experience
  • Previous experience in the pharmaceutical or other related industry is preferred.