*Please share the resume with *manish.gu...@nityo.com

*Role: Validation Lead Tester*

*Relevant Experience (in Yrs) : 5 – 8 years*

*Duration of assignment (in Months): 12 Months*

*Work Location : Allendale, NJ (4- four)  & Kalamazoo, MI (2 - two)*

*Technical/Functional Skills:*

•        Very good experience is SDLC and Computer Systems Validation (CSV)

•        Agile Methodology experience preferred

•        Supply chain experience preferred. Experience working with SAP ECC

•        Infrastructure Qualification experience

•        High level knowledge working with HPALM

•        Experience working in a cross functional system and within scrum

•        Experience in Software validation and compliance activities in
Pharma (GMP) environment

•        Experience in working with GxP applications

•        Experience in creation/maintenance & implementation of SOPs

•        Experience in the use of HP Quality Center and similar tools to
manage software testing and requirements.

•        Worked in cGMP, 21 CFR Part11 and GAMP 5 environment

•        Hands on authoring/ review/ approval of computer system validation
deliverables, inclusive of requirements gathering.  Functional
specification, test/validation plans, protocols, test scripts / cases,
traceability matrix and summaries

*Roles & Responsibilities:*

•        Ensures documentation and practices meet quality standards,
applicable regulatory compliance and IS guidelines/policies

•        Review functional design specification, technical design
specifications for clarity, Good documentation practices.

•        Review the accuracy and completeness of software validation
deliverables created by process work streams

•        Knowledge of software testing. Ability to create Traceability
Matrices linking approved requirements to test cases within HPALM.

•        Create validation deliverables like Requirements, Data Migration
Plan, Summary Reports, work instruction documents for tools

•       Ability to pull necessary details from an object level Technical
Design Specs and Functional Design specs  and consolidate the information
in a Master          Technical and Functional Design document that is
presentable to an external regulatory agency.

•        Experience working in an agile environment is preferred

•        Keep the Program Validation Lead/Validation Project Manager
informed of any issues regarding the quality of deliverables or any
potential sources of impact to the project timeline.

Report on the status of validation deliverables and support other
compliance work as necessary

*Generic Managerial Skills:*

•        Very good communication skill with strong customer relationship
management skills

•        Proactive and Innovative.

•        Good analytical skills. Should be able to evaluate a situation and
take right decisions.

•         Should be able to own the activities and drive for completion.

Capabilities to host meetings, capability of handling multiple projects,
multiple stakeholders and Conflict resolution.


*Manish Gupta*

Desk: 609-853-0818 Ext-2130

Fax : 609 799 5746



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