Trainee – Quality – APQR Hiring B Pharm, MSc, M Pharm | Apotex Mumbai

Apotex Hiring: Trainee – Quality – APQR Opportunities in Mumbai

Looking for a rewarding career in the pharmaceutical industry? Apotex, a leading global health company, is hiring for the role of Trainee – Quality – APQR in Mumbai. This position is ideal for candidates with a background in B.Pharm, MSc., or M.Pharm, and a passion for ensuring high-quality standards in pharmaceutical products.

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About Apotex

Apotex Inc. is a Canadian-based pharmaceutical leader dedicated to manufacturing affordable, high-quality medicines accessible across 75+ countries. With over 7,200 employees globally, Apotex focuses on the development and commercialization of generic, biosimilar, and specialty medicines, ensuring better healthcare worldwide.

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Job Overview

Position:

Trainee – Quality – APQR (Annual Product Quality Review)

Location:

Mumbai, Maharashtra, India – 400079

Employment Type:

Full-time

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Responsibilities of a Trainee – Quality – APQR

As a Trainee in Quality Assurance, your primary responsibilities will include:

• Perform Annual Product Quality Reviews (APQRs) compilation as This includes the following at minimum, as per SOP:
  • Manufacturing Process Overview
  • Batches Released / Rejected
  • APIs, Excipients
  • Changes
  • Test Method and Specification

• Manufacturing / Process Validation, Equipment and Utilities Qualification
• Sterility Validation / Qualification (If applicable)
• Packaging Component Deviations/Changes
• Compendial Review
• Deviations
• Critical In-Process Attributes
• Analytical Test Results
• Recalls and Field Alerts, Returns
• Retention Samples Review
• Technical Agreements (as appropriate)
• Marketing Authorizations Variations and Post Market Commitments (as appropriate)
• Complaints
• Stability
• Conclusion and Product Rating
• Concerns, Recommendations and Issues for Follow-Up
• Perform complete and correct transactions of the data as per SOP / WI’s.
• Summarize and trend analytical data from LIMS or other acceptable systems.
• Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
• Co-ordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects.
• Compile the APQRs within required timelines to ensure that there is adequate time for approvals.
• Responses to Project Leader’s queries for APQR summary reports as required.
• Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required.
• Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards.
• Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
• 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.

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Qualifications and Skills

Educational Requirements:

• B.Pharm, MSc., or M.Pharm with a strong academic background.

Experience:

• Minimum of 1–2 years in the pharmaceutical industry, preferably in Quality Assurance.

Key Skills:

• Strong technical writing and communication skills.
• In-depth knowledge of cGMP standards.
• Ability to work collaboratively within teams and independently.
• Excellent organizational and problem-solving abilities.

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How to Apply

Candidates can apply for this exciting opportunity through the official Apotex Careers Portal.

Tagged as: Global Pharma Jobs, Pharmaceutical Careers, Pharmaceutical Jobs