Executive-acon-csv-bangalore - Bengaluru, India - KPMG India

KPMG India

Verified Company

Bengaluru, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

The key job responsibilities include the following:

At least 2-4 years of computer system validation in a pharmaceutical/medical devices environment
Good knowledge of regulations and software lifecycle approaches (e.g., 21 CFR part 11, 210, 211 Part 820, ICH Q9, ISO 13485, GAMP, SDLC methodologies)
Experience in the validation of software and tools in a regulated environment.(e.g,, ERP, Solution Manager, Document Management, CAPA, LIMS etc.) and Infrastructure Qualification.
Experience in development of Validation Master Plans for systems or equipment's.
Ensures documentation and practices meet quality standards, applicable regulatory compliance, and company guidelines/policies
Authoring, reviewing and executing computer validation documentation (Validation Plan, URS, FRS, FRA, IQ, OQ, PQ, RTM, summary report)
Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing
Review the accuracy and completeness of software validation deliverables created (e.g. Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities
Accurately report the status of assigned deliverables and support other compliance work as necessary
Strong communication skills, proficiency in MS Office suite
Travel across locations and regions.