Pharma Trainee Job at Apotex Inc! Apply Online
Trainee – Quality Stability Data
Date: Nov 4, 2024
Location: Mumbai, MH, IN, 400079
Company: Apotex
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients worldwide. Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations, making its medicines accessible in over 75 countries. The Apotex group focuses on developing and selling generic, biosimilar, and specialty products through vertical integration.
For more information, visit: www.apotex.com.
Job Summary
Responsible for summarizing and reviewing stability data to ensure Apotex commercial products’ shelf lives are supported. Provide required stability data to customers for their product compliance files.
Job Responsibilities
- Prepare Stability Summary Reports within compliance time frames.
- Ensure summary reports are accurate and complete as per Apotex procedures.
- Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
- Review stability data from third-party affiliates for compliance.
- Perform Stability Impact Assessment for out-of-trend results at drug product release as per approved procedures.
- Review and evaluate stability data to ensure no significant trends warrant attention and that the approved shelf life remains justified.
- Provide Annual Stability Review contribution packages to the QA Product Review group for the Annual Product Quality Review (APQR); notify the Assistant Manager of any adverse trends.
- Work effectively as a team member to meet departmental goals and share knowledge with team members.
- Maintain compliance with all health and safety standards, Good Manufacturing Practices, Good Documentation Practices, and regulatory requirements.
- Adhere to all local safety regulations, Apotex’s Health and Safety policies, and Safe Work Procedures.
- Perform work supporting Apotex’s Corporate Values of Courage, Collaboration, Passion, and Perseverance; demonstrate strong and visible support of these values.
- Work safely, collaborating as a team member to achieve all outcomes.
- Exhibit behaviors that align with Apotex’s Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- Complete all other relevant duties as assigned.
Job Requirements
Education:
- Master’s Degree in Science/Pharmacy
Knowledge, Skills, and Abilities:
- Good understanding of pharmaceutical Quality Control systems.
- Demonstrated knowledge of stability requirements.
- Strong interpersonal skills and a results-oriented team player.
- Ability to work with minimal supervision.
- Ability to communicate findings to the Assistant Manager and escalate any critical issues arising from the Stability summary report.
- Ability to work within intra/inter-departmental teams to complete work in a timely manner to meet business and quality standards.
- Good written and verbal communication skills.
- Experience with Microsoft Office applications is an added advantage.
If you are interested in this position, please apply here.
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