- - 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.

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.
- Robust 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.

📌 Quality Control Associate - UTM (Universal testing machine ) (Secunderabad)
🏢 Monster - xshruthix
📍 Secunderabad