Senior Analyst, Annual Product Quality Review
Senior Analyst, Annual Product Quality Review
Apotex
Job description
If you want to build a career in quality assurance consider the Senior Analyst, Annual Product Quality Review position at Apotex in Mumbai.
Company Description
Apotex is a company that works worldwide to give people affordable new medicines. It sells generic, biosimilar and branded drugs, plus consumer health items. The company is based in Toronto. Has offices in the United States, Mexico, India and other places. Apotex is a Canadian pharmaceutical company and a trusted health partner in the Americas.
Job Summary
The Senior Analyst, Annual Product Quality Review job is about putting together Annual Product Quality Reviews that follow the company’s operating procedures (SOPs). They will gather, examine and write up product review information quickly and correctly. They will handle tasks like batch review, deviation checks and analysis of stability data. The Senior Analyst will also work closely with QA project leaders to keep reviews on time and ready for audit.
Key Responsibilities
Compile Annual Product Quality Reviews that cover manufacturing, batches and test results.
Review changes, deviations and updates to packaging components for accuracy.
Study data on critical process attributes and analytical test results.
Track recalls, field alerts, returns and reviews of retention samples.
Review complaints, stability data and technical agreements when needed.
Summarize product ratings, conclusions and follow‑up recommendations.
Complete all data transactions accurately following SOPs and work instructions.
Analyze and trend data using LIMS or similar systems.
Submit completed reviews for approval by reviewers and project leaders.
Coordinate with project leaders to keep review timelines on track.
Respond to queries about APQR summary reports.
Support the preparation, review and updating of SOPs when required.
Follow GMP guidelines, safety standards and regulatory requirements at all times.
Work independently and within cross‑departmental teams.
Educational Qualification
B. Pharm, M. Pharm or Master of Science (MSc) degree.
Skills Required
2 - 4 years of experience in the pharmaceutical industry focusing on Quality Assurance.
Strong knowledge of SAP transactions used in product review processes.
Understanding of international regulatory requirements for product reviews.
Strong technical writing and communication skills.
Ability to spot improvements in data gathering and reporting processes.
Strong knowledge of GMP guidelines and safety standards.
Ability to work independently and within a team environment.
Salary Structure
The average annual salary of a Senior Analyst, Annual Product Quality Review at Apotex is ₹4.9 Lakhs to ₹5.5 Lakhs per year.
Career Development
This role gives hands‑on exposure to quality review processes at a leading pharmaceutical company. Apotex supports long‑term growth with a values‑driven culture that values collaboration, courage and continuous learning.
How to Apply
Visit our job portal and search for the Senior Analyst, Annual Product Quality Review role - Apotex.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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