Team Member Service Engineer QC (Visakhapatnam)

Team Member Service Engineer QC (Visakhapatnam)

13 Nov
|
Dr. Reddy's Laboratories
|
Visakhapatnam

13 Nov

Dr. Reddy's Laboratories

Visakhapatnam

1. Laboratory Instrument Management
Installation qualification and maintenance of QC instruments.
Coordinate IQ/OQ/PQ activities for new equipment.
Ensure instruments are calibrated and fit for use.
Maintain instrument status labels and calibration records.
Examples of instruments:
HPLC (High Performance Liquid Chromatography)
GC (Gas Chromatography)
UV-Visible Spectrophotometer
FTIR
Dissolution Test Apparatus
TOC Analyzer
Particle Size Analyzer
2. Preventive Maintenance
Plan and execute preventive maintenance schedules.
Coordinate with OEMs and service vendors.
Track AMC/CMC contracts and service reports.
Minimize instrument downtime.
3. Breakdown Handling
Attend instrument breakdowns and troubleshoot issues.
Raise service requests with vendors.
Ensure timely restoration of equipment.
Document root cause and corrective actions.
4. Documentation & Compliance
Maintain equipment logbooks.
Review calibration and maintenance records.
Prepare SOPs related to instrument operation and maintenance.
Ensure compliance with cGMP GLP and data integrity requirements.
Qualification & Validation Support
Support Analytical Method Validation activities.
Execute instrument qualification protocols.
Assist during instrument requalification.
Software & Data Integrity Management
Manage chromatography software such as:
Empower
Chromeleon
Lab Solutions
User account management.
Audit trail review support.
Backup and archival of electronic data.
Utility Monitoring
Monitor laboratory utilities:
Compressed Air
Nitrogen
Water Systems
HVAC Systems
Temperature & Humidity Controls
Vendor Coordination
Coordinate with external service providers.
Follow up on quotations service reports and spare parts.
Verify service completion and performance.
Regulatory Audit Support
Support USFDA MHRA WHO and customer audits.
Present equipment qualification and maintenance records.
Address audit observations related to laboratory instruments.
Training
Train analysts on proper equipment operation.
Conduct refresher training on SOPs and GMP requirements.
Maintain training records.

Qualifications :

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:
3 to 6 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)
Positive 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.

Additional Information :

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation.



With a legacy of excellence we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The perks 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

Remote Work :

No

Employment Type :

Full-time

📌 Team Member Service Engineer QC (Visakhapatnam)
🏢 Dr. Reddy's Laboratories
📍 Visakhapatnam

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