- Mentor Technical Group (Juncos, PR)
- …Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control , Laboratory Testing, Project Management and Quality ... Method Validation (Experience preferable) + Strong knowledge and experience with quality process management + Basic Knowledge on equipment preventive maintenance and… more
- Mentor Technical Group (Juncos, PR)
- …* Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry * Fully bilingual communications skills (English and Spanish) * Good ... communications and presentation skills in English and Spanish * Project management skills * Strong organizational skills, including ability to follow assignments through to completion * Enhanced skills in leading, influencing and negotiating * Knowledge of and… more
- Mentor Technical Group (Juncos, PR)
- …Mexico, Germany, Canada, and South America. Responsibilities: + Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control ... approvals as per the compliance requirements. + Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with… more
- Quality Consulting Group (Juncos, PR)
- …field corrective actions, CAPA, or product quality management. + Experience on Quality Systems & CAPA, Change Control and Validations. + Solid understanding ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical,...external stakeholders. + Proficiency in Microsoft Office Suite and quality management systems (QMS). + Strong technical writing. +… more
- Mentor Technical Group (Juncos, PR)
- …and installation phases. + Perform risk assessments and identify critical quality attributes (CQAs) and critical process parameters (CPPs). + Document and ... and regulatory standards. + Collaborate with engineering, manufacturing, and quality teams to ensure seamless equipment qualification and process transfer.… more
- Mentor Technical Group (Juncos, PR)
- …document lifecycle using electronic document management systems (EDMS), including version control , approvals, and archival. + Support internal and external audits by ... industry (pharma, biotech, medical devices) with direct experience in SOP writing or quality documentation. + Knowledge of regulations such as FDA 21 CFR Part 11,… more