Job title: Validation Qualification Engineer – Lab

Company: Stryker

Job description: Work Flexibility: Onsite

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate
• Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do:

• 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, Instrons/ 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.

What you need:

• 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
• Working knowledge of EQ/ AMV/ PV/ CSV/ MSA/ PSP/ Stats analysis where required etc. knowledge of any LIMS/ software documentation system.
• 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

Travel Percentage: None

Expected salary:

Location: Gurgaon, Haryana

Job date: Wed, 09 Feb 2022 23:37:39 GMT

Apply for the job now!