Team Member – Analytical Quality Assurance
Quality Assurance – GMO
Location: Pydibimavaram
Department: Quality Assurance
Company: Dr. Reddy’s Laboratories
Company Overview
Dr. Reddy’s Laboratories is a global pharmaceutical organization focused on accelerating access to affordable and innovative medicines.
Key Highlights
Founded in 1984
Presence in 66 countries
24,000+ employees worldwide
Focus areas:
Scientific excellence
Regulatory compliance
Sustainability
Affordable healthcare innovation
Job Summary
This role is part of the Analytical Quality Assurance function and focuses on ensuring compliance in Quality Control (QC) laboratory operations.
The role ensures:
Analytical data integrity
Regulatory compliance
Investigation management (OOS/OOT/deviations)
Documentation and audit readiness
Continuous quality improvement in laboratory systems
Key Responsibilities
1. Quality Management System (QMS) Investigations
Participate in investigations related to:
Out of Specification (OOS)
Out of Trend (OOT)
Laboratory deviations
Ensure timely closure of QMS documents as per SOP timelines
2. Trending & Data Analysis
Prepare trending reports for:
OOS results
OOT results
Laboratory incidents
Support:
Root cause analysis
CAPA identification
Continuous process improvement
3. CAPA & Change Control Review
Evaluate:
Change control requests
CAPA action plans
Verify effectiveness of implemented corrective and preventive actions
Ensure prevention of recurrence of deviations
4. Analytical Data Review & Compliance
Review all QC laboratory data including:
Raw data
Electronic records
Ensure compliance with SOPs and data integrity requirements
Review audit trails for GxP systems
5. Equipment & Calibration Review
Review instrument calibration records
Ensure reliability of analytical instruments
Confirm adherence to GMP and GLP standards
6. Stability & Reference Standards Management
Prepare and review:
Stability sample documentation
Reference standards records
Impurity and working standards documentation
Ensure compliance with applicable procedures
7. System & SAP Activities
Perform and verify SAP transactions for:
Laboratory workflows
Data entry and traceability
Ensure accuracy and SOP compliance
8. Laboratory Compliance Monitoring
Ensure implementation of:
cGLP (current Good Laboratory Practices)
SOP adherence in QC and microbiology labs
Manage QMS notifications via DCMS system
9. Method Validation & LIMS Oversight
Review and approve:
Method validation protocols
Method transfer reports
Review LIMS master data updates and control limits
Approve stability study protocols in LIMS
Educational Qualifications
Mandatory
Graduation in:
Chemistry, OR
Analytical Chemistry, OR
Pharmacy
Preferred
Master’s degree in:
Microbiology
Biochemistry
Biotechnology
Chemistry / Analytical Chemistry
Pharmacy
Experience Requirements
2–4 years of relevant experience in Quality Assurance / QC environment
Technical Skills
Candidates should have expertise in:
Compliance & Quality Systems
GMP (Good Manufacturing Practices)
GLP (Good Laboratory Practices)
QMS (Quality Management Systems)
Regulatory compliance systems
Laboratory & Analytical Skills
Chromatography techniques (HPLC, GC)
FTIR and UV-Vis spectroscopy
Instrument calibration and validation
Method transfer and validation processes
Data Integrity & Regulatory Standards
21 CFR Part 11 compliance
EU Annex 11 compliance
Electronic data review and audit trail analysis
Documentation & Systems
Technical documentation review
Change control systems
SAP and LIMS systems
Risk management processes
Behavioral Competencies
Accuracy & Discipline
Strong attention to detail
Ensures error-free and compliant documentation
Ownership
Proactively identifies risks and deviations
Takes accountability for investigations and equipment readiness
Continuous Learning
Shares knowledge with team members
Supports troubleshooting and laboratory excellence
Critical Exposure Requirements
Candidates should ideally have experience in:
GMP/GLP and global regulatory compliance
Handling OOS/OOT investigations and deviations
Analytical techniques such as HPLC, GC, FTIR, UV-Vis
Data integrity compliance (21 CFR Part 11 / Annex 11)
Troubleshooting laboratory deviations
Exposure to advanced instruments (preferred):
LC-MS
ICP-MS
NMR
Work Culture
Dr. Reddy’s Laboratories promotes:
Patient-first philosophy (“Good Health Can’t Wait”)
Quality and compliance-driven operations
Continuous improvement mindset
Collaboration and teamwork
Inclusive and diverse workforce culture
Benefits
Competitive compensation and benefits
Medical coverage for employee and family
Life insurance coverage
Maternity & paternity support
Learning and development programs
Relocation and onboarding support
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