Team Member - Analytical Quality Assurance

Job Summary
Roles & Responsibilities
 

• Review and approval of all analytical test data of Quality control.
• Review and usage decision of analytical reports in LIMS Empower and SAP.
• Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments.
• Review the Analytical test report in LIMS.
• Review the reported results against specification and trends.
• Review the method validation and method transfer documents.
• Review the instrument calibrations and working standard qualification records.
• Handling the Incidents/ Deviations Out of Trends Out of Specification including investigations Corrective and Preventive actions follow up and closure.
• Monitoring of analytical activities in Quality control laboratory.
• Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval.
• Verification and review of the audit trails for Standalone Empower and LIMS.
• Ensure cGMP / cGLP compliance.
• To follow Safety Health and Environmental procedures and practices.
• Review and approval of excel sheet validations.
• Review results acceptance for API and Excipients and Packing material.
• Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols.
• Handling of Robotic Process Automation of Chromatography Data review (RPACD)
• To carry any other activities assigned by upward reporting staff.

Qualifications :

Educational qualification: A Bachelors/Masters degree in Pharmacy Chemistry Chemical Engineering or a related field

Minimum work experience: 3 to 7 years of experience in QC or AQA department is mandatory.


 

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