Team Member Quality Control (In-Process)

Job Summary

The role of Team Member Quality Control (QC) involves performing routine analytical testing of raw materials intermediates in-process samples and finished products (API) in compliance with GMP GLP and GDP requirements. The position is responsible for operating and calibrating laboratory instruments (such as HPLC and other analytical equipment) ensuring adherence to approved specifications test procedures (STP) and methods of analysis (MOA).

The role includes maintaining laboratory standards such as proper documentation data integrity housekeeping and safety practices during chemical handling. The individual ensures readiness of instruments reagents and materials prior to analysis including verification of calibration status validity of chemicals and preparation of solutions.

Additionally the job involves recording and reporting analytical results including handling deviations such as OOS (Out of Specification) and OOT (Out of Trend) supporting method verification/transfer activities maintaining records and coordinating through systems like MES for sample release and tracking.

The role also requires participation in training programs analyst qualification instrument maintenance coordination and ensuring smooth shift handovers with any additional responsibilities as assigned by supervisors.

Roles & Responsibilities

• Ensure compliance with GMP GLP and GDP 
• Follow QC laboratory entry and exit procedures.
• Perform analysis of raw materials intermediates in-process samples APIs stability samples and working standards.
• Operate analytical instruments (HPLC etc.) as per approved SOPs.
• Ensure instrument calibration before analysis and perform periodic calibration.
• Verify SPEC and MOA parameters prior to analysis.
• Prepare mobile phase reagents and solutions as per procedures.
• Check validity of chemicals reagents solvents and standards before use.
• Use cleaned and dried glassware for all analyses.
• Ensure proper column selection conditioning and washing procedures.
• Monitor Milli-Q water quality (resistivity) before use.
• Follow injection sequence as per STP before analysis.
• Record and maintain analytical raw data and documentation accurately.
• Ensure chromatograms are clear and legible.
• Store test solutions until batch release.
• Report OOS OOT results and incidents immediately.
• Perform method transfer and method verification studies.
• Release in-process samples through MES system.
• Maintain inward registers and closing records.
• Raise work orders and breakdown requests for laboratory maintenance.
• Maintain records such as HPLC lamp hours usage.
• Ensure good housekeeping in the laboratory.
• Follow safety precautions while handling chemicals and solvents
• Complete assigned LMS trainings and analyst qualification.
• Ensure proper shift handover..
• Perform additional tasks assigned by HOD/designee.

Qualifications :

Educational qualification: An . degree in Chemistry

Minimum work experience: 2 to 6 years

Skills & attributes:

Technical Skills
HPLC 

GC

Empower data processing

Wet analysis

Behavioural skills
Attention to detail and commitment to ensuring compliance with QMS (Quality Management System) documents including OOS (Out-of-Specification) OOT (Out-of-Trend) and Incident investigations.
Ability to respond to internal and external audits and participate in other QMS-related activities.
Strong organizational skills for LIMS (Lab Information Management System) related activities.
Effective communication and collaboration skills for coordinating and implementing of SOPs.

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 benefits 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 Work :

No

Employment Type :

Full-time