Quality Control Associate UTM (Universal testing machine )

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• Perform device functionality tests using Universal testing machine in accordance with approved SOP Methods specification and protocols.
• Responsible to perform lot release testing stability testing of batch following good laboratory and good documentation practices.
• Review test results against approved specification and report OOS OOT results to the supervisor
• Ensure planning timely execution and completion of testing and documentation within defined TAT. Support trending and evaluation of stability data.
• Conduct In process inspections and functionality testing during manufacturing activities. Execute testing for method validation method transfers Design verification studies generate data and support preparation of study reports
• Ensure timely entries in SAP/ LIMS for test results.
• Maintain test records raw data sheets and electronic records in compliance with ALCOA principles
• To ensure timely completion of trainings in LMS.
• Coordinate for sample retrieval Receive verify label samples from cross functional teams for batch release stability and protocol studies.
• To report Laboratory failures deviations upon observation and support the addressal of the same through proper investigation reports preparation and timely closure of CA/PA.
• Contribute to audit preparedness and regulatory inspections

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  Secondary Responsibilities:

   

• Follow GLP SOPs and laboratory safety guidelines.
• Ensure data integrity and compliance with quality standards.
• To adhere and follow safety procedures as per SHE.
• To perform activities as per MSI role.

Qualifications :

Required Qualifications

• Bachelors/Masters degree in Analytical Chemistry Chemistry Biotechnology Biochemistry Life sciences or related field.
• 2-5 years of hands-on experience in medical device testing.
• Strong analytical troubleshooting and documentation skills.

Preferred Skills

• Hands on experience with Universal testing machine(UTM)
• Experience in batch release and stability testing.
• Knowledge in LIMS and electronic data management
• Familiarity with SOPs GDP GMP and data integrity requirements
• Proficiency in Microsoft excel word Power point presentation and data analysis
• Ability to manage multiple samples while maintaining high data quality and turnaround time.

Additional Information :

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon...

Benefits Offered

At Dr. Reddys we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddys are on par with the best industry standards...

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...

For more details please visit our career website at Work :

No

Employment Type :

Full-time