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 to assess if Cleaning Validation Protocol studies are required.
• Generates Cleaning Validation protocols/studies, and subsequent reports. 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, 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.
• Provides coaching to technicians and operators involved in cleaning validation activities.
• Provides presentations on validation topics as required to Validation team members, and potentially to outside departments and organizations.
• 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

• 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 industry