Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.
Currently, one of our clients is looking to hire a Specialist QA to provide services in the East Region of Puerto Rico.
Requirements:
- Bachelor’s degree in Science/ Engineering and 4 years of experience in Quality Systems such as Deviations, Non-conformities, CAPA, Change Control and data integrity concepts.
- 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
- Strong communication (both written and oral), facilitation and presentation skills.
- Fully Bilingual in English and Spanish- Required
Job Types: Full-time, Contract
Experience:
- New Product Introduction: 4 years (Required)
- Validation: 4 years (Preferred)
- Document review: 4 years (Required)
Language:
- Spanish and English (Required)
Work Location: In person