QA Lead for NPI & Validation | Bilingual (English/Spanish)
FITS LLC
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Job summary
FITS LLC in the United States (Puerto Rico, Juncos area) seeks a QA professional to support NPI activities and ensure regulatory compliance within the pharmaceutical sector. You will review MPs, approve validation protocols, and participate in incident triage and site audits.
The role requires a Bachelor's degree with 4+ years of pharma experience, bilingual English/Spanish, and strong project management. It involves working on process validation, Change Control, FATs, and CAPA handling in a
Qualifications
- Bachelor's degree with four years of experience in the pharmaceutical or regulated industry.
- Bilingual in English and Spanish.
- Demonstrated Project Management skills.
- Shift: Administrative shift, and according to business needs.
- Experience in NPI, Change Control, FATs, Validation, and PPQs.
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.
Skills
Education
Job description
FITS LLC in the United States (Puerto Rico, Juncos area) seeks a QA professional to support NPI activities and ensure regulatory compliance within the pharmaceutical sector. You will review MPs, approve validation protocols, and participate in incident triage and site audits.
The role requires a Bachelor's degree with 4+ years of pharma experience, bilingual English/Spanish, and strong project management. It involves working on process validation, Change Control, FATs, and CAPA handling in a
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