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
Nice to have
Positive 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
Mandatory Skills : Computer System Validation(CSV) - Testing