Hello,
Hope you are doing well.
This is Bharat from Nityo Infotech. Please find the JD below and if you have any consultant available then please let me know ASAP at Bharat.c@nityo.com.
Validation Lead
Allendale, NJ
Contract 12 months
CSV, Validation Lead, GxP, Agile, ERP implementation
JD-
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 preferable.
· Infrastructure Qualification experience
· High level knowledge working with HPALM
· Experience with MS Office applications.
· Experience working in a cross functional system and within scrum teams.
· 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.
|
Nityo Infotech Corp. Suite 1285 Plainsboro, NJ 08536 |
Regards
Bharat Chhibber Fax : 609 799 5746
|
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