Dr.Reddys Laboratories
Designation : Team Member
Function : Quality Assurance
Functional Area : QC, Analytical
Job Role Summary : Investigation of Laboratory incidents, OOS, OOT, QMS documents, Change management, Reviewing Analytical documents
Job Profile :
- 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
Job Requirements :
- 2+ years experience in Pharma Quality control, Analytical QA functions
- Experience handling Laboratory investigations, Laboratory Document review, Analytical Instrumentation
Work / Job Experience : 2+ Years
Type of Experience : Pharma QC, Analytical QA experience
Academic Qualifications :
- 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
