About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.

 

Job Summary

Responsible for coordinating and assisting in various Computer System Validation Compliance (CSVC), change controls, system implementation projects and eCompliance initiatives/activities for all GxP impacting Computer Systems as QA responsible in accordance with regulations and defined Apotex quality standards and policies.

Role of the Computer System Validation Compliance (CSVC) at GBS Quality, following are the deliverables.

Change management (QMS) Computer System Validation Compliance (CSVC) Deviations / Investigations / CAPAs Projects & Improvement Initiatives / Ad hoc Assignment as needed Job Responsibilities Change Management (QMS) Change Control Records in QMS TW and GXP assessment Act as a QA Responsible for Computerized System changes control, as well as other change types (as applicable). Ensure timely review of the assigned change control records associated with all types of enterprise software electronic systems utilized across global sites as a QA Responsible. Support GXP assessment process for various applications and systems. Perform all applicable duties as QA responsible/Global QA CSVC in timely manner. Maintain procedures to regulate change implementation (Change Control Procedures) to ensure system compliance through its life cycle. Process improvements Assist in generating general best practice documents or internal working standards documents pertaining to change management. Attend CSVC QA/QMS monthly forum as required. Computer System Validation Compliance (CSVC) Biannual review of Standard changes Perform the biannual quality audit review of standard changes as QA CSVC responsible; review will be applicable for the defined period of current year based on previous review. Identify random number of standard changes completed by GIS for different systems and coordinate with GIS-CSV for completed copies. Review standard changes and identify any findings. Coordinate with GIS-CSV for completed copies Complete biannual review form and submit to QA CSVC for final review and approval. CSVC Validation Approach Conduct review of CSVC related procedures and practices as required. Conduct review and approval of validation documents such as User Requirement Specifications, Validation Plans, Periodic Review Report, Decommissioning plan, Decommissioning Report, Validation Summary Reports, and other documents as a CSVC QA responsible as per defined validation approach and Global Validation Master Plan. Assist in to ensure areas of CSVC QA and e-Compliance are aligned with global quality objectives. Assist in developing and/or maintaining procedures/tools for validation and compliance with cGMP impacting computer systems to all regulations including 21CFR Part11. Deviations / Investigations / CAPAs Assist in supporting CSVC related CAPAs, deviations and investigations as required. Training Maintain qualified trainer status for applicable Quality System courses and conduct training as required. Projects & Improvement Initiatives / Ad hoc Assignment as needed Support with planning and executing task assigned for on-going projects/initiatives and any ad hoc assignments Assist with hosting both internal and external audits as required. Other Responsibilities Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Pharm/ B.Sc. /M. Pharm/ M.Sc. (Organic Chemistry, Analytical chemistry) Knowledge, Skills and Abilities Well versed knowledge of Quality Assurance function in GxP Regulated Pharmaceutical Industry. Good understanding of GMP’s (Good Manufacturing Practices) regulatory requirement etc. in GxP regulated environments (GMP, GLP, cGMP, GEP). and GAMP standards including validation process. Good Knowledge of Computer System Validation (CSV) and compliance, e-compliance, GAMP 5, FDA’s 21 CFR Part 11, Annex 11 and other ER/ ES regulations. Knowledge and hands on experience of SDLC (Software development Life Cycle) in preparation / approving URS, PVP, FS, CS, FLRA IQ, OQ, PQ, VSR, SRC and other qualification protocols and reports for computerized systems. Well versed knowledge and hands on experience on review and approval of key CSV/qualification documents to cover all aspects validation of the computerized system(s) & non-computerized system which impacts GxP and SDLC. Well versed knowledge of Quality Assurance, Quality Control, Manufacturing, GIS, Engineering departments in GxP Regulated Pharmaceutical Industry. Knowledge on QMS system (Handling of Change Control, Deviations, Investigations, CAPAs, Training, QMS operational activity) is must. Experience in handling of SAP, TrackWise enterprise system, and other software. Knowledge and experience of Good Documentation Practices, Data Integrity compliance, Regulatory Quality Audit (Internal/HA) for GxP regulated area under QMS and CSV. Excellent Leadership and Interpersonal Skills, effective people management skills, team communication. Good Verbal and Written communication skills is Must. Experience Minimum 5 to 7 years of validation experience in GMP regulated industry. Experience in Quality Assurance, Computer System Validation (CSV) and compliance, eCompliance, Part 11, Annex 11, Data Integrity, QMS system (Core 4-6 Years QA CSVC & eCompliance experience is preferable)

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
 
Apotex offers 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.