Team Member - Quality Control
Role Overview
Perform quality control analysis of pharmaceutical raw materials, in-process samples, finished products, and stability samples.
Conduct laboratory work in compliance with approved specifications, SOPs, cGMP, USFDA, ICH, and audit requirements.
Key Skills for This Role
Full Job Posting
Role overview
Perform quality control analysis of pharmaceutical raw materials, in-process samples, finished products, and stability samples.
Conduct laboratory work in compliance with approved specifications, SOPs, cGMP, USFDA, ICH, and audit requirements.
Laboratory analysis
- Analyze APIs, excipients, in-process materials, finished products, and stability samples.
- Execute testing with HPLC, GC, UV-Visible spectrophotometer, dissolution apparatus, Karl Fischer, and IR or FTIR instruments.
- Perform stability-sample analysis and trending and complete assigned samples on time.
Instrument operations
- Operate and maintain analytical instruments including HPLC, GC, dissolution, FTIR, and Karl Fischer equipment.
- Perform routine checks, system suitability testing, and troubleshooting.
Documentation and compliance
- Record raw data in notebooks and LIMS according to ALCOA+ principles.
- Maintain traceable documentation without overwriting or loose sheets.
- Review analytical data for accuracy and compliance.
- Follow cGMP, GLP, data-integrity, and regulatory guidelines.
Investigations and improvement
- Assist with OOS, OOT, deviation, and incident investigations.
- Support root-cause analysis and implementation of CAPA.
Qualifications and required skills
- M.Sc. in Chemistry or B.Pharm.
- Experience using Empower and LIMS software is required.
- Strong knowledge of analytical techniques such as HPLC and GC.
- Understanding of cGMP, data integrity, regulatory expectations, and electronic data management systems.
- Good documentation and communication skills.
About the company
Dr. Reddy’s Laboratories is a multinational pharmaceutical company with research, manufacturing, and commercial operations across global locations.
The company focuses on access, affordability, innovation, sustainability, and science-driven healthcare.
About drreddyslaboratorieslimited
Indian multinational pharmaceutical company developing and manufacturing affordable generic, branded-generic, biosimilar, and over-the-counter medicines.
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