Quality Control Associate LIMS

• Hands-on experience in LIMS master creation revision and review support
• Knowledge of specifications sample plans test methods calculations inventory schedules reagent masters and stability masters.
• Understanding of LIMS workflow configuration approval workflows and audit trail requirements.
• Experience in challenge testing and verification of configured masters against approved source documents
• Understanding of QC analytical microbiology stability raw material packing material and bioassay testing processes.
• Familiarity with specifications STPs methods protocols and laboratory workflows.
• Knowledge of analytical techniques such as HPLC UPLC TOC BET CE-SDS HCD HCP particle count and environmental monitoring
• Ability to interpret SOPs Work Instructions Specifications Forms Validation Reports Qualification Protocols and JOS documents.
• Understanding of change controls deviations CAPAs OOT/OOS requirements and audit trail review expectations.

Qualifications :

Educational qualification: An . Biotechnology Microbiology Biochemistry

Minimum work experience: 3 years

Skills & attributes:

Technical Skills
1) Basic understanding of the Biologics/Biosimilar industry including processes regulations and trends.
2)Hands-on experience in LabWare LIMS master data creation
3)Ability to do process mapping of a procedure.

4)ability to identify gaps in the existing process flows.

5)Design create master data and execute dry runs for verification.

6)Effective communication with end users CFTs line QA regarding the master data.

7)Design logics and verification through dry runs.

8)Execution of test scripts to enable qualification of instruments new modules as per process flows.

Behavioural skills
Prioritizes effective communication and demonstrates a performance-oriented mind-set.
Effective verbal and written communication skills.
Performance-oriented approach consistently striving for high standards.
Demonstrates flexibility in working shifts and a clear understanding of team dynamics.

Additional Information :

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