Specialist - Quality Engineering

Role description

Requested by Murali

Validation Engineer

Backfill for Sudhanshu Kumar(10822229)

RR for Validation Engineer Experience in Computer System Validation and Quality Assurance Software Testing activities for Life Sciences Applications IT Process implementation Optimization from compliance to regulations standards to regulatory in spections waterfall to agile perspectives from Pharmaceutical Company Proficient ISO 270012013 Internal Auditor Training ICH GDP ERES GAMP and GAMP5 Certified in ISO IEC 277012019 GDPR Lead Implementer Training Experience in QMS set up Proce ss Definition SOP Creation SQA activities Validation activities GXP Compliance and Good Documentation Practice Sound Knowledge in 21 CFR Part 11 and GXP and GAMP Ownership of End to End Validation Process Collaboration with Project Management I ntegration Management to drive Application Development and Maintenance Projects Involved in Trace ability Matrix Management Creation of VP VR IQ Baseline Reports in AD Projects with ISPDM process Provided End to End support in tracking revie w ing and approving all the quality deliverables in projects Involved in Supporting Audit Management Related Activities Internal External

Common

Good communication and presentation skills

Worked in business client facing role

Highly driven energetic flexible resourceful ability to multitask

Clarity of thought and vision

Ability to ideate and bring solutions to the table

Adherence to timelines without sacrificing quality of output

Hands on and detail oriented with a strong ability tocoo rdinate across different Geographies and with different stakeholders

Ability to manage multiple functions at same point of time

Skills

Mandatory Skills : Computer System Validation(CSV) - Testing