Quality Control Associate - UTM (Universal testing machine )

Quality Control Associate - UTM (Universal testing machine )

Company Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

"

Job Description

•  

• 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

•  

  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

• Bachelor’s/Master's 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 10–15-year time horizon...

" Benefits Offered

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

" Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions...

For more details, please visit our career website at https://careers.drreddys.com/#!/

"

Experience Level

Mid Level