Thursday, January 19, 2017

Validation Lead =======Kalamazoo, MI

Job Title

Validation Lead

Relevant Experience
(in Yrs)

6– 8 years

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.

Duration of assignment (in Months)

12 months

Work Location

Kalamazoo, MI

--
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.

No comments:

Post a Comment

AddThis Smart Layers

Attention

The job offers on this web site are not related with jobs724.blogspot.com and the owner of the website. These job offers indexed by RSS feed from Google Groups about Online Job offers, Software Jobs, IT Jobs, Recruiters&Consultants, USA Jobs etc. This site does not reserve any rights to, nor claims copyright to, any software names listed on these pages. All references are copyright to their respective owners. If you want to apply for any job, you need to contact with the owner of job, not with any admins of jobs724.blogspot.com. If you have any doubts about legality of content or you have another suspicions, feel free to contact us.

Find the latest software jobs, Talent from US and Canada. ASP.NET, VB.NET, C#, ADO.NET, Consultamcy, ASP.NET, VB.NET, C#, ADO.NET, Consultamcy SAP, client-server, e-commerce and web development etc., SAP APO Green Card H1B, B1, JAVA J2EE, RMI, XML, weblogic, websphere JDBC

Stay Updated!

We have indexed IT job opportunities and counting! Don't miss any chance. Subscribe us and get the latest IT jobs listings to your inbox!

Jobs Archive