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, M.Sc., or M.Pharm, and a passion for ensuring high-quality standards in pharmaceutical products.
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.
Job Overview
Position:
Trainee – Quality – APQR (Annual Product Quality Review)
Location:
Mumbai, Maharashtra, India – 400079
Employment Type:
Full-time
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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Trainee - Quality - APQR Hiring B Pharm, MSc, M Pharm | Apotex Mumbai[/caption]
Qualifications and Skills
Educational Requirements:
- B.Pharm, M.Sc., 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.
How to Apply
Candidates can apply for this exciting opportunity through the official
Apotex Careers Portal.
https://pharmastuff.org.in/job/trainee-quality-apqr-apotex-mumbai
