Technical Lead
2 weeks ago
- looking for a pure validation resource with periodic review, audit experience.
- We are 10 + years Experience in Validating GxP applications.
- Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy.
- Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality Support Risk assessment.
- Document Regulatory Requirements and Review Specification documentation (viz. User Stories, URS, FRS).
- Review and final Approval of requirements, Technical Design and Solution Architecture Plan, IQ, OQ and PQ pre and post execution documents Lead, Write, Review/ Approve Discrepancy Logs (final dispositions).
- Lead, Write, Review / Approve Requirement Traceability Matrix (RTM) and Validation Summary Reports.
- Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification.
- Conduct Periodic Reviews of GxP Apps as per the frequency stated in the governing SOP and write Periodic review reports and Review and Approve Periodic Review Reports.
- Tracks the Periodic review findings and open CAPA s to a closure.
- Review and Approve System Support and Operations plan.
- Participate in and support Audits.
- Contribute and Review/ Approve Decommissioning Plans & Decommissioning Reports.
- Contribute, Review/ Approve deliverables for Change Management Support.
- Maintain validation documentation throughout product lifecycle viz.as result of Change, Periodic Review, Audits Communication.
- Immaculate communication and handles multiple clients/ projects
- To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents.
- Co-ordination with On-Site Engineers and attending customer calls.
- Raising risks, issues and escalation to senior management and customer.
- To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities..
- To create project plans and keep track of schedule for on time delivery as per the defined quality standards
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Technical Recruiter
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Technical Recruiter
2 days ago
Raleigh, United States Technical Source Full timeTechnical Source is a growing technical staffing and consulting firm looking for a money-motivated, customer-service oriented Technical Recruiter to join our team. As an Technical Recruiter with Technical Source you will be directly responsible for supporting pharmaceutical and biotech engineering operations in the Triangle. Technical Source offers the...
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Technical Recruiter
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Raleigh, United States Technical Source Full timeTechnical Source is a growing technical staffing and consulting firm looking for a money-motivated, customer-service oriented Technical Recruiter to join our team. As an Technical Recruiter with Technical Source you will be directly responsible for supporting pharmaceutical and biotech engineering operations in the Triangle. Technical Source offers the...
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Technical Recruiter
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Raleigh, United States Technical Source Full timeTechnical Source is a growing technical staffing and consulting firm looking for a money-motivated, customer-service oriented Technical Recruiter to join our team. As an Technical Recruiter with Technical Source you will be directly responsible for supporting pharmaceutical and biotech engineering operations in the Triangle. Technical Source offers the...
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Technical Lead
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