Team Member Analytical QC

Biopharma Careers

Hyderabad

On-site

INR 600,000 - 1,000,000

Full time

10 days ago
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Benefits offered by this job

Relocation assistance
Medical coverage for employee and/or家

Job summary

Dr. Reddy's Laboratories in Hyderabad is seeking a qualified laboratory professional to uphold GMP/GLP standards, perform calibration of analytical instruments, and ensure accurate documentation.

The role covers QC, SAP/LIMS tasks, method validation support, and adherence to data integrity principles, with emphasis on safety and laboratory cleanliness.

2+ years of experience in a chemistry or analytical chemistry environment is required; advanced certifications are preferred.

Qualifications

  • Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory.
  • Masters in related fields preferred.
  • Additional Certifications like CQA, RAC, Six Sigma are preferred.

Responsibilities

  • Follow GMP/GLP compliance and SOPs.
  • Calibrate and verify analytical instruments as per master schedule.
  • Prepare records of analysis and analytical test reports.
  • Manage LIMS and SAP QC activities.
  • Initiate CRN, OOS and incidents; assist investigations.
  • Support process validations and cleaning validations.
  • Review activities requiring second-person witness and ensure traceability.
  • Maintain laboratory chemicals and reagents.

Skills

Regulatory Compliance
Regulatory Filings
Technical Documentation
Change Control
Laboratory Information
Risk Management
Chromatography

Education

Bachelor's in Chemistry/Analytical Chemistry or Pharmacy
Master's in Microbiology/Biochemistry/Biotechnology/Chemistry/Analytical Chemistry or Pharmacy
Certifications: CQA, CPGP, CBSP, Six Sigma, RAC

Tools

LC-MS
ICP-MS
NMR
HPLC
UV-Vis

Job description

Job Summary

Responsible to follow good laboratory and safety practices in the laboratory.

Responsible to follow good documentation practices in the laboratory.

Responsible to ensure the cleanliness of the laboratory.

Responsible for calibration of analytical instruments and Equipment's.

Responsible to carry out calibration / performance verification of analytical Instruments and Equipment's as per master schedule.

Responsible to participate in process validations and cleaning validations.

Responsible to perform analysis of In-process and Finished product samples.

Responsible to check and Review of activities wherever the second person witness is required (Objective evidence is not available).

Responsible to maintain laboratory analytical standards as per the laid down procedures.

Responsible to maintain laboratory Chemicals and reagents.

Responsible to perform QC related SAP activities.

Responsible to execute LIMS related activities

Responsible to initiate CRN, OOS and incidents.

Responsible for preparation of record of analysis and analytical test report.

Any other assignment given by higher management.

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.
Benefits Offered

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

The benefits 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/#!/

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