Company Description
ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.
To provide high quality, professional quality assurance and quality management services to the pharmaceutical industry. Duties will be carried out in accordance with the ADAMAS Quality Management System (QMS) including business and personal objectives as agreed during the annual performance appraisal process.
Assist in Development, implementation, and maintenance of computerized system's state of validation and compliance throughout its SDLC.
Assist, Author/Review in Preparation of CSV deliverables such as Validation Plan, Test Plan, Summary Reports
Assist in supporting CSV vendor and system process audits
Assist in supporting CSV and QMS internal audits
Assist in authorship, generation, and execution of validation documents (System Testing, IQ, OQ, PQ, UAT), for GxP regulated computerized systems
Review test scripts including IQ, System Testing and UAT scripts.
Perform Data Integrity, Supplier Qualification and FDA 21Part 11 assessments.
Assist in support computerized systems change management control and periodic review processes.
Exploring new opportunities to add value to organization and departmental processes
Helping others to accomplish results
Performing other duties as assigned
Qualifications
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