Contract Opportunity========Validation Lead in Allendale, NJ

POSITION-     Validation Lead
LOCATION-    Allendale, NJ

Duration – 12 Months
      

 

·        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.

 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
 Regards,
Atul Sharma
IT -recruiter
atul@idctechnologies.com
Direct: 408.418.5778  EXT 3027

 

 




 
  

--
You received this message because you are subscribed to the Google Groups "US Jobs: Requirements, Clients and Consultants" group.
To unsubscribe from this group and stop receiving emails from it, send an email to recruiters-r-us+unsubscribe@googlegroups.com.
To post to this group, send email to recruiters-r-us@googlegroups.com.
Visit this group at https://groups.google.com/group/recruiters-r-us.
For more options, visit https://groups.google.com/d/optout.