Team Member – Analytical Quality Assurance

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 laboratoryincluding electronic and raw dataensuring 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.

Management of QMS notifications through DCMS.

Monitor and ensure cGLP (current Good Laboratory Practices) in Quality control and Micro Lab and implementation of standard operating procedures.

Verification of audit trails for all the GxP computer systems at Quality Control Laboratory.

Preparation Review and approval of stability study protocols on LIMS.

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
Minimum work experience:
2-4 years of 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.
 

Additional Information :

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :

No

Employment Type :

Full-time