Hi Associates,
Mail your Hotlist to [email protected] Please mail your consultants Resume to [email protected] Submit the candidates who is on your own payroll. Complete Job Description will be sent on request. H1 B copy needed before submission. H1 B transfer will not work. *Multiple Openings :* *Opening : : CSV Lead : : Somerset, NJ : : Full Time / C2C / CTH : : Any Visa* *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 improvements. - 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 standards - 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 *Thanks,* *Ram * *Direct : **408-933-9951* *Office: 408-709-1760 Ext: 9723* [email protected] -- You received this message because you are subscribed to the Google Groups "Hot List" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/directclienteq. For more options, visit https://groups.google.com/d/optout.
