Senior Executive, QA Validation & Engineering

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

Job Summary

Shall involve actively in the execution and act as a reviewer of validation and qualification documents in the validation section. Be a subject matter expert in the validation section and shall ensure compliance in all the activities performed.

Job Responsibilities

• General
• Preparation of Validation Master Plan (VMP) and SOP’s related to validations section
• Co-ordination, assessment and review of change control, notification, deviation in the quality management system related to validation activities.
• Coordinate and participate in the quality risk management (QRM) exercise related to facility, utility, equipment and process carried out in the facility.
• Shall carryout gap assessment against global procedures/regulatory requirements and address gaps ensuring compliance.
• Act as coordinator for periodic self-inspection of validation section for evaluation of the effectiveness of the quality systems.
• Maitaining adherence to regulatory requirements and ensure the validation section is ready for audit anytime.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• All other duties as assigned.
• Qualification
• Act as Subject matter expert (SME) for qualification and validation protocols related to equipments, utilities
• Review/approval of periodic requalification documents pertaining to equipment / system / utilities and instrument of various departments across ARPL.
• Review/approval of annual schedules for calibration, qualification status review, qualification, AMC, cleaning & sanitization, preventive maintenance and filter replacement etc.
• Approval of layouts, yearly & monthly schedules, to be added planners, New logbook request etc.
• Cleaning Validation
• Act as Subject matter expert (SME) for cleaning validation
• Responsible for evaluation of products for cleaning validation, preparation of cleaning validation matrix, performing MACO calculation, preparation of Equipment Cleaning Process Design Document (ECPDD), .cleaning validation protocols and reports, Quarterly/Annual monitoring reports for cleaning validation
• Responsible to carryout cleaning validation activities in eResidue Pro software application
• Process Validation
• Act as Subject matter expert (SME) for process validation
• Responsible for review/approval of documents related to process validation for demonstration batch, Optimization batch, Technical Risk Assessment, Process Performance Qualification, packaging validation protocols and reports, Continuous process verification and hold time study protocols and reports.
  
  

Job Requirements

• Education :
• Master degree in Pharmacy/ Science or any equivalent degree.
• Knowledge, Skills and Abilities
• Possess sound knowledge in Qualification of Equipment, facility and utilities.
• Maintains good Interpersonal skills and communication skills.
• Strives to drive projects related to Qualification effectively
• Experience
• Minimum 6 years of experience in GMP Regulated pharmaceutical industry
  

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.