Novartis has announced an opportunity for an Associate Analyst – Quality Operations in Hyderabad for candidates interested in pharmaceutical quality, Quality Assurance, GMP compliance and Annual Product Quality Review (APQR) activities.
This Novartis Quality Operations job in Hyderabad primarily involves handling Annual Product Quality Reviews, extracting and interpreting quality data, compiling information from internal systems and external suppliers, reviewing documentation and supporting timely completion and approval of APQRs.
Candidates with a bachelor’s or master’s degree in a related technical discipline and approximately 1–3 years of professional experience in Quality are desirable for this position.
For candidates building careers in pharmaceutical Quality Assurance, Quality Operations, APQR, GMP, QMS and quality compliance, this role provides exposure to product-quality review processes within a global pharmaceutical organization.
About the Role
As an Associate Analyst – Quality Operations at Novartis, the selected candidate will support Annual Product Quality Review activities.
The role requires extracting information from relevant tools and applications, interpreting quality data, compiling supplier APQR information and data from Novartis systems into predefined templates, and supporting conclusions regarding product quality and robustness.
The position also involves coordination with suppliers, manufacturing sites and relevant quality stakeholders.
Key Responsibilities
The major responsibilities of the Novartis Associate Analyst Quality Operations role include:
- Collect contributory reports required for product-related quality evaluations.
- Coordinate with suppliers and manufacturing sites when required.
- Support maintenance and updating of the Annual Product Quality Review schedule.
- Compile APQR reports and associated quality data.
- Review APQR information for completeness and accuracy.
- Help ensure Annual Product Quality Reviews are completed within established timelines.
- Support archival of approved APQR documentation.
- Communicate with external suppliers regarding approved supplier APQRs and associated documents.
- Follow up on delays in receiving Product Quality Reviews and supporting documentation.
- Inform relevant stakeholders and Quality Assurance Managers when delays occur.
- Support distribution, tracking and approval of APQR documentation.
- Update approved APQR information in applicable quality files/systems.
- Interpret compiled quality data to support conclusions regarding product robustness.
- Support maintenance of Country Quality Review schedules.
- Coordinate with relevant manufacturing, packaging, testing and batch-release sites.
- Compile and consolidate data required for Country Quality Reviews.
- Review compiled information for accuracy and completeness.
- Submit finalized Country Quality Reviews to relevant Country Quality teams.
- Ensure appropriate archival of approved Country Quality Review documentation.
Qualification – Which Degrees Can Apply?
The official Novartis job description specifies a bachelor’s or master’s degree in a related technical discipline or equivalent demonstrated experience.
Depending on the relevance of the candidate’s academic background and experience, potentially suitable qualifications may include:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc / M.Sc Chemistry
- B.Sc / M.Sc Biotechnology
- B.Sc / M.Sc Microbiology
- B.Sc / M.Sc Biochemistry
- B.Tech / M.Tech Biotechnology
- Other relevant pharmaceutical, scientific or technical disciplines
Important: The individual degree examples above are an interpretation of the broader “related technical discipline” requirement and are not an exhaustive degree list explicitly stated by Novartis. Candidates should verify their eligibility against the official job posting before applying.
Experience Required
Novartis lists 1–3 years of professional experience in Quality as a desirable requirement.
Experience or exposure in the following areas can be particularly relevant:
- Pharmaceutical Quality Assurance
- Quality Operations
- Annual Product Quality Review (APQR/PQR)
- Good Manufacturing Practices (GMP)
- Quality Management Systems (QMS)
- Quality Compliance
- Product Quality Review
- Pharmaceutical manufacturing quality
- Quality documentation
- Data review and interpretation
Skills Desired
Candidates interested in the Novartis Associate Analyst Quality Operations job should have or develop competencies in:
- Good Manufacturing Practices (GMP)
- Quality Assurance (QA)
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Compliance
- Data Integrity
- Data Monitoring
- Statistical Process Control
- Process Control
- Regulatory Inspections
- Deadline Management
- Communication
- Collaboration
- Health and safety regulations
Attention to detail is especially important because the position involves compiling, interpreting and reviewing quality information for accuracy and completeness.
Why This Quality Operations Role Is Important
Annual Product Quality Reviews are an important component of pharmaceutical quality systems. They help organizations periodically evaluate product and process information and identify trends that may affect product quality.
Novartis describes its Quality Management System as a structured approach designed around applicable regulatory requirements and standards, including principles of the ICH Q10 Pharmaceutical Quality System. Its quality framework incorporates periodic product and process reviews, quality indicators, risk assessments, audits and inspections.
For an Associate Analyst, exposure to APQR activities can therefore provide practical experience in pharmaceutical quality systems, GMP documentation, data integrity and product lifecycle quality management.
Benefits of Working at Novartis
While compensation and individual benefits depend on employment terms and company policies, this opportunity may provide:
- Experience with a global pharmaceutical organization
- Exposure to pharmaceutical Quality Operations
- Hands-on experience with APQR/PQR processes
- Experience working within GMP and quality-management frameworks
- Cross-functional interaction with manufacturing sites, suppliers and Quality teams
- Exposure to quality data interpretation and documentation
- Professional development within the pharmaceutical Quality function
Candidates should refer to Novartis’ official careers information for the applicable employee benefits and rewards.
Who Should Apply?
This opportunity may be particularly relevant for professionals with 1–3 years of Quality experience who want to develop their careers in pharmaceutical Quality Operations.
Candidates with experience in QA, APQR/PQR preparation, GMP documentation, QMS, pharmaceutical manufacturing quality, quality compliance or product-quality documentation may find their background particularly aligned with the responsibilities.
Job Location
Hyderabad, Telangana, India – Office
How to Apply
