- Prepare SOPs, protocols, perform qualification and validation of lab equipment (s)/ methods.
- Discuss with team members/ equipment (s) owner to understand the qualification/ validation requirement.
- Understand, plan and qualify the equipment(s)/ methods as per the schedule requirement discussed with team.
- SME/ stakeholder's meetings and use of validation software to document qualifications and to maintain it.
- General use handling of lab equipment (s) viz. LAF, BSC, autoclave, device washer, spectrophotometer, ultrasonic and hot/cold bath, incubators, Instron's/ UTMs, Fixture designed for testing, other mechanical instruments, and equipment qualifications for the same.
- Support team members to create or improve procedures, policies, processes, systems, and technology requirements.
- Deliver high quality results with passion, energy, and drive to meet business priorities.
- Working area experience in equipment qualification/ method validation activities in Pharma/ medical devices industry with a minimum of 5+ Years of Experience.
- Knowledge of USFDA, ANVISA, EU and other regulatory bodies requirement for equipment qualification/ method validation
- Knowledge/Understanding and ability to use - different standards like AAMI, USP, ANSI, EPA, EU ISO 13485, ISO 17025, Quality Management Systems for Medical Devices 21 CRF 820 and GMP.
- Strong experience QMS and Risk Analysis tools & techniques.
- Understanding on Medical Device Development Life Cycle process and testing will be given weightage
- Understanding of various documentation required for testing.
- Good communication and team skills