Location: Navi Mumbai
Department: Information Technology
Direct Reportees: NA
Reports To: Head IT
JD- Executive Computer System Validation (CSV).
Candidate must have CSV Documentation execution experience as Doer and reviewer.
Candidate must have end to end CSV experience of at leat 5 -10 Manufacturing equipments, 5-10 Quality instruments, 4-5 Opertion technology (OT) systems like Empower, Labsolution, DAS, Serilisation etc..
Working experience to act as a liaison between the business functions and the technical team.
Candidate must have experience of coordinating for Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems
Must have experience to prepare Standard Operating Procedures (SOPs) of IT Dept, periodic review, revision, training and implementation.
Candidate will be responsible for handling QMS documents , preparation of schedule, change control, CAPA , Deviation etc…
Working experience to act as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management.
Candidate must have experience of Validation of Software Applications, Computer systems.
Candidate must have experience in GxP Analysis, Gap Assessment, ERES Assessment
Candidate must have experience of Software Quality control/assurance and Risk Management.
Candidate must have experience to review of GAMP Guidelines
Candidate must understand and ensure applicability of Computer System Validations for the complex change management environment as operating in regulatory compliance framework
Candidate must have knowledge of 21 CFR Part 11 and Annexure 11 of USFDA, EU, MHRA
Candidate must have experience of working in FDA regulated environment with good understanding of cGxP.
Candidate must have knowledge of evaluating changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes
Working experience of system administration and support and Knowledge to provide input into and maintenance procedures to ensure adequate controls for maintaining the validated state.
Must have experience of handling internal external audits.
Candidate must have knowledge to assist investigation team of deviations and reporting of results of such investigation.
Qualification:
B.E./B.Tech./MCA/MBA/M.Sc/B.Pharm/M.Pharma.
Professional Experience:
Computer System Validation 4-5 years experience as DOER and REVIEWER.
Other requirements:
Ability to work in a team environment, effectively interacting with others.
Experience in a leading pharma company preferred.
Ability to multitask and manage multiple deliverables and projects at the same time.
Should be able to travel to other plant (if applicable).
About Company Future is an IT consulting firm that specializes in the design, implementation, and support of all Information Technology...
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