Hi Associates,

Mail your Hotlist to r...@tresourceinc.com

Please mail your consultants Resume to  r...@tresourceinc.com

Submit the candidates who is on your own payroll.

Complete Job Description will be sent  on request.

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*Multiple Openings :*

*Opening : : CSV Lead : : Somerset, NJ : :  Full Time / C2C / CTH : : Any

*Job Responsibilities:*

Overall Project Overview:

   - Develop a plan for the validation of computer and automation systems
   ensuring compliance to required regulatory requirements.
   - Partner with the Global IT Compliance organization to gain in-depth
   understanding of guidelines, requirements and general expectations related
   to Computer Systems Validation and Compliance
   - Deliver validation activities in compliance with US and EU regulations.
   - Participate in the design of systems and equipment, if needed, to
   ensure that they comply with GMP/GCP/GLP requirements.
   - Compile relevant documentation from contractors, suppliers, and other
   departments for inclusion in reports.
   - Initiate and implement change control activities in accordance with
   site procedures.
   - Compile and analyze validation data and make recommendations for
   - Participate on cross-functional project teams with the support of
   Validation activities.

Leadership Responsibilities:

   - Manage a team of CSV contractors in the development and execution of
   all validation documentation specific to the defined application
   development (Project ) consistent with Clients' SDLC and IT Compliance
   - Give guidance on all activities related to computer and automation
   system validation.
   - Prepare and deliver regular updates and communications (verbal and
   written) to the team and extended business partners regarding the progress
   of the Validation work stream.
   - Review and approve documents prepared by the validation team, other
   departments and contractors (e.g. test plans, impact assessments, change
   controls, etc.).
   - Contribute directly to the completion of projects through the
   management of assigned contract personnel, if applicable.
   - Coordinates and executes training of required personnel on the
   computer and automation systems validation procedures and methodology.
   - Prioritize qualification activities in line with the project schedule.

Day to Day Technical Responsibilities:

   - Author relevant validation documentation (e.g. Master Plans, Test
   Scripts, Templates, etc.), as defined by the Client's IT SDLC methodology.
   - Execute all relevant validation protocols and test procedures, as
   defined by the Clients' IT SDLC methodology
   - Develop validation documentation as required (e.g. specifications,
   user requirements, plans, protocols, procedures, traceability matrix,
   error/defect reports, etc. ).
   - Execute qualification protocols as required.
   - Prepare reports of executed protocols for review by QA.
   - Track and resolve exceptions during qualification activities.
   - Proactively resolve conflicts between compliance requirements and
   project/business constraints.
   - Co-ordinate validation activities with IT, Business, QA activities.

*Skills and Experience Required:*

Mandatory Requirements:

   - 10+ Years: *Computer System Validation*
   - 6-8+ Years: BIO/Pharmaceutical industry experience
   - 5+ Years: Demonstrated leadership in SDLC/CSV, IT Compliance and/or IT
   Quality Assurance
   - *Experience with Managing/Training Offshore resources.*
   - Experience with equipment controlled by ERP, *LIMS*, EMS, PMS, and
   other Quality and Development Laboratory systems.
   - *Thorough knowledge of cGMP regulations related to CSV including 21
   CFR Part 11, and GAMP standards are required.*
   - Root cause analysis; experience investigating and troubleshooting
   automation and control systems
   - Strong leadership skills and the ability to work in cross-functional
   team environments, as well as independently, and to manage multiple and
   competing projects are required.
   - *Strong written and verbal communication skills*
   - Knowledge of MS Office, SharePoint, MS Project, and Visio.

Desired Requirements:

   - Knowledge/familiarity with U.S. and Global regulatory registration of
   drug products is preferred.
   - International, cross culture, and cross functional experience desired
   - Project management skills


*Ram *

*Direct : **408-933-9951*

*Office: 408-709-1760 Ext: 9723*


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