Job Role –
1) CSV, Quality IT, QMS, TMS, Auditing and Project Management.
2) Strong understanding of GAMP, USFDA, 21 CFR Part 11, EU GMP Annexure II.
3) Data integrity definitions and guidance of MHRA, WHO guidance on good data management and compliance system.
4) Preparation and/ or review of Validation/ Qualification documents such as Project plan, Validation plan, User requirements, Traceability Matrix, Computer System Validation etc.
5) To carry out a risk assessment for computerized system preparation.
6) Review and upgrade the QMS procedures, and IT/ Digital change control records.
7) Strong Interpersonal and presentation Skills are required.
– Interested candidates may share their updated CVs on firstname.lastname@example.org with the subject captioned “Application for Quality-IT.”