Specialist - Quality Engineering

Role :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

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