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*Multiple Openings :*
*Opening : : CSV Lead : : Somerset, NJ : : Full Time / C2C / CTH : : Any
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
- Compile and analyze validation data and make recommendations for
- Participate on cross-functional project teams with the support of
- 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
- 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
- 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
- Co-ordinate validation activities with IT, Business, QA activities.
*Skills and Experience Required:*
- 10+ Years: *Computer System Validation*
- 6-8+ Years: BIO/Pharmaceutical industry experience
- 5+ Years: Demonstrated leadership in SDLC/CSV, IT Compliance and/or IT
- *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.
- 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
*Direct : **408-933-9951*
*Office: 408-709-1760 Ext: 9723*
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