Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI in Puerto Rico.
Description:
Perform one or more of the following duties and responsibilities in support of the client Quality Assurance program under minimal supervision.
Responsibilities:
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
Competencies / Skills:
- Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
- Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
- Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
- Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning, facility, utility, and equipment qualifications.
Education:
- Master's degree and 3 years of directly related experience o Bachelor's degree and 5 years of directly related experience years of directly related experience.
Compensation and Benefits:
- Employment (W2) and Professional Services Contract (480) available.
- Administrative, as per business need.
- Competitive Pay Rate
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
