• US Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 16th Aug 2022

10+ years as an IT Quality Assurance Specialist within Pharma/Lifesciences

Ability to work on multiple concurrent projects

Ability to work effectively in a fast-paced geographically dispersed team setting

Ability to work successfully with cross functional teams

Experience with use of MS Office Tools e.g. PowerPoint, VISIO, MS Word, Excel, Outlook, TEAMS

10+ years of CSV (Computer System Validation) experience for GAMP-5 category 3, 4, and 5

Working knowledge of GxP Processes

Experience in infrastructure qualification

Experience with Quality Systems (e.g. change control, deviations, testing defects, CAPA)

Ability to work within a fast-paced, large company environment

Excellent written and oral communication skills, presentation skills, and soft skills

Responsible for performing an independent quality review and approval of computer system validation and infrastructure qualification deliverables in alignment with internal procedures and government regulations

Support computer system validation projects and the validation lifecycle of existing and new computerized systems used for pharmaceutical and biotech processes

Knowledge with quality and IT frameworks, approaches, tools, methodologies (i.e., GAMP, ISO, ITIL, SDLC, COBIT, Computer Software Assurance (CSA) etc.)

Understanding of Quality, Regulatory and Compliance best practices including knowledge of 21 CFR Parts 11, 210, 211 requirements, Data Integrity, ICH Q7A requirements, and GAMP 5

Must have an advanced understanding of the validation and qualification lifecycle and all applicable phases including planning, testing, reporting and change control

Able to analyze and propose solutions for compliance issues and deviations

Experience in the use of Application Lifecycle Management (ALM) or other automated testing tools is desirable