QA Validation & Compliance Reviewer

MENTOR Technical Group Corporation; Vega Baja (PR); Vor Ort; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading technical support firm in Puerto Rico seeks a Validation Specialist to review and audit validation and verification activities in pharmaceutical manufacturing. The role requires a Bachelor's or Master's degree in Chemical Engineering or a related field, along with proven experience in compliance with cGMP regulations. Strong analytical and communication skills are essential, along with bilingual proficiency in English and Spanish. This position offers a dynamic work environment focusing on regulatory impact assessments and product quality improvements.

Qualifikationen

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
• Proven experience in validation, qualification, and verification within a pharmaceutical manufacturing environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Experience with Change Control processes and regulatory impact assessments.
• Excellent skills in reviewing and writing technical documentation.

Aufgaben

• Review and audit validation, qualification, and verification activities across various functions.
• Participate in defining validation/qualification strategies for product changes.
• Review and approve OQ, PQ, and Verification activities and SOPs.
• Coordinate Change Requests for qualified production records and systems.
• Support activities related to new R&D products including documentation.

Kenntnisse

Validation

Qualification

Verification

Analytical Skills

Problem-Solving Skills

Communication Skills

Experience in cGMP

Technical Documentation

Bilingual: English and Spanish

Ausbildung

Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or related field

Tools

MS Office applications

Jobbeschreibung

A leading technical support firm in Puerto Rico seeks a Validation Specialist to review and audit validation and verification activities in pharmaceutical manufacturing. The role requires a Bachelor's or Master's degree in Chemical Engineering or a related field, along with proven experience in compliance with cGMP regulations. Strong analytical and communication skills are essential, along with bilingual proficiency in English and Spanish. This position offers a dynamic work environment focusing on regulatory impact assessments and product quality improvements.