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Trainee-GBS-AGOSS G

4 weeks ago

Mumbai, Maharashtra, India Apotex Inc. Full time
Job Description

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 creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports) for Apotex.
- Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.
- Responsible to escalate any critical issues arising from the MMaR / MPaR while drafting.

Job Responsibilities

- Creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports).
- Migration of MPPDs into new MMaR & MPaR templates.
- Manage own workload and completion of assigned MMaR & MPaR within established cycle time commitments.
- Execution and Cancellation of documents in Content Server.
- Creation and peer review of MDocs for Cancellation CCRs.
- Drafting and review of MMaRs and MPaRs for Richmond Hill Site.
- Responsible for Primary Technical Writer role for change control process for cancellation of documents for Signet and Etobicoke sites.
- Working on creation of Change Control Records for Packaging Material codes cancellation for Richmond Hill site.
- Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.
- Perform all work in compliance with current SODs and GMPs.
- 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 Team leader.
- Develop and maintain effective working relationships with internal and external customers.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and Collaboration; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- 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

- Bachelors/ Masters 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 years 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.