Apotex Inc.
Website:
apotex.com
Job details:
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
- Responsible for impact analysis/handling of Master Manufacturing and Packaging records (MPPDs).
- Responsible to escalate any critical issues arising during working on MMaR, MPaR, and Change Controls.
Job Responsibilities - Responsible for Creation/Review/Execution/Cancellation for Master Production and Packaging Documents (MPPD) and Material Masters and Master recipes for GTA sites.
- Collaborate with cross functional teams and Quality to perform a thorough and complete impact analysis for the change control package, including but not limited to the following:
- Facilitate the compiling of supporting documentation (i.e. Mark-ups, reports).
- Ensure all related documents and data affected by a change request are captured.
- Ensure changes outlined in the change management system coincide with mark-ups and/or proposed change.
- To generate and manage the Investigation sub-records (i.e. F8s and F9s) and follow ups for blocking/unblocking of Product masters in SAP for GTA sites.
- Responsible for handling of Weekly and Monthly reports / Initiate TO Project Acceptance Approval Form/ F8- Bulk M2M/Readiness-Lighthouse for GTA sites as needed.
- Ensure all changes are aligned with cGMP regulations and corporate SODs.
- Serve as a technical resource to internal/external customers and key stakeholders in the development of Master Production & Packaging documentation.
- Provide support for the interpretation and incorporation of recommendations coming from Validation and Technical Operations for the updating of commercial master documentation.
- Review the accuracy of all manufacturing instructions imported into master documents during detailed Impact Analysis as listed in the scope of the change request.
- Working in partnership with teams of highly experienced individual contributors to execute and deliver project results by leveraging expertise in mentoring, relationship building, strategic thinking and team building.
- Develop and manage working relationships with Business Stakeholders to assess their needs, determine customer service levels and manage service delivery, becoming a trusted strategic partner.
- Facilitate cross-functional discussions ensuring all items and issues have been resolved and/or escalated to the appropriate individuals in the interest of Manufacturing Support.
- Report anomalies and communicate any changes required for correcting discrepancies found in all Master Production and Packaging Documents
- Develop and revise Standard Operating Documents governing and relating to Manufacturing Support functions as required.
- Ensure compliance with current Standard Operating Procedures and Work Instructions related to Document Specialist activities and report errors and inconsistencies associated with approved procedures to the People leader.
- Develop and maintain effective working relationships with internal and external customers.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage, and Innovation.
- 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
- Bachelor’s/ Master’s degree in Science / Pharmacy
- Knowledge, Skills and Abilities
- Should be proficient in MS office tools.
- Should have excellent verbal & written communication skills.
- Experience of working on online modules / software would be an added advantage.
- Working knowledge of a document management system required.
- Ability to be flexible and multi-task in a rapidly changing environment.
- Experience
- Minimum 0-1 year of experience in the Pharmaceutical industry.
At Apotex, we are committed to fostering a welcoming andaccessible 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.
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