Associate, MTS - Cleaning Validation

Job Summary

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

Job Responsibilities

• Liaises with key business members to generate CV Product and Equipment Risk Assessment reports, when evaluating new and/or changes to product formulations and manufacturing equipment.
• Generates Cleaning Validation protocols/studies, and subsequent reports.
• Co-ordinates the cleaning validation event activities (sampling, cleaning, testing requests).
• Executes cleaning validation/verification events:
  • LIMS project generation and sampling preparation,
  • Perform visual inspection and sampling of equipment,
  • Delivers samples to the laboratory, 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, communicates results for equipment release, and summarizes data for validation reports.
• As necessary, evaluates, maintains and orders sampling supplies.
• Recommends changes to equipment cleaning procedures and sampling methods to allow for successful completion of cleaning validation studies.
• Initiates and recommends changes to SODs, and master documents pertaining to cleaning validation.
• Performs impact assessment, in conjunction with the management team, for proposed changes to production equipment and cleaning procedures on the validation program using the appropriate change control procedures.
• 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.

Job Requirements

• Education
  • Bachelor's degree in Science or Engineering is preferable.
• Knowledge, Skills and Abilities
  • Demonstrated knowledge of cleaning validation concepts.
  • 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
  • Minimum of 2 years experience in the pharmaceutical or other related