Job Summary

This role is for a Quality Assurance Specialist - Analytical Compliance, responsible for ensuring end-to-end adherence to regulatory standards and SOPs in Quality Control (QC) laboratory operations, with a focus on analytical data integrity, investigation management, and documentation oversight.

Roles & Responsibilities

. You will be responsible for participating in investigations of Quality Management System (QMS) documents such as OOS, OOT, and laboratory deviations, and ensuring timely closures as per SOP timelines.

. You will be responsible for preparing trending reports for OOS, OOT, and laboratory incidents, using analytical insights to support CAPA identification and process improvements.

. You will be responsible for evaluating Change Controls and CAPA action plans, verifying their effectiveness to ensure resolution of root causes and prevention of recurrence.

. You will be responsible for reviewing all analytical data generated in the Quality Control laboratory-including electronic and raw data-ensuring accuracy and compliance with relevant SOPs.

. You will be responsible for reviewing instrument and equipment calibration records and audit trails to confirm reliability, data integrity, and GMP adherence.

. You will be responsible for preparing and reviewing documentation related to stability samples and ensuring that reference standards, impurity standards, working standards, and related records are maintained per applicable procedures.

. You will be responsible for performing and verifying SAP transactions related to laboratory workflows and data entries as outlined in SOPs, ensuring traceability and accuracy.

. You will be responsible for reviewing and approving method validation and method transfer protocols and reports, as well as LIMS master data and control limit updates, ensuring analytical consistency across platforms.

Qualifications

Educational qualification:



Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory

Masters in Microbiology, Biochemistry, Biotechnology, Chemistry/Analytical Chemistry or Pharmacy is preferred

Additional Certifications like CQA, CPGP, CBSP, Six Sigma, ICH Q5/Q6, Advanced Biologics Manufacturing or RAC are preferred

Minimum work experience:

2+ years experience

Skills & attributes &Critical; exposures

Functional Skills

. Regulatory Compliance

. Regulatory Filings

. Technical Documentation

. Change Control

. Laboratory Information

. Risk Management

. Chromatography

Resident Skills

. Product Quality (QA/QC)

. Current Good Manufacturing Practices (cGMPS)

. Good Laboratory Practice (GLP)

. Quality Management Systems (QMS)

Behavioural Skills

. Accuracy & Discipline - Upholds rigorous documentation and testing standards to ensure error-free, compliant results.

. Ownership - Proactively identifies risks, supports investigations, and maintains equipment readiness with accountability.

. Continuous Learning - Shares knowledge with new joiners, troubleshoots effectively, and contributes to laboratory excellence.

Critical exposures

. Experience in ensuring compliance with GMP, GLP, and global regulatory standards is desired.

. Exposure to executing analytical tests using techniques like HPLC, GC, FTIR, and UV-Vis, ensuring adherence to SOPs and regulatory requirements is preferred.

. Experience in maintaining accurate documentation and ensuring compliance with data integrity principles such as 21 CFR Part 11 and Annex 11, is desired.

. Experience in troubleshooting like Out-of-Specification (OOS)



results and non-conformances, applying analytical methodologies to resolve deviations, is desired.

. For SME - Advanced Instrumentation: Experience in operating and maintaining advanced analytical instruments such as LC-MS, ICP-MS, and NMR, ensuring method development and validation, is desired.

. For SME - Statistical Analyst (Biologics): Experience in applying biostatistical methods for analyzing biologics data and process validation, using software like SAS or JMP, is desired.

Additional Information

Benefits Offered

At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.

The perks you will enjoy at Dr. Reddy's are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit.

And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success.

We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website at https://careers.drreddys.com/#!/

📌 Team Member - Analytical QA (Baddi)
🏢 Monster - xshruthix
📍 Baddi