GMP Compliance Consultant

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 over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide. We are seeking an experiencedGMP Compliance Consultantwith deep expertise inChina pharmaceutical regulationsandoral solid dosage (OSD) manufacturingto support a U.S.-based pharmaceutical facility. Bachelor’s degree, with a minimum of 5 - 10 years of relevant experience. Extensive experience in GMP compliance within the pharmaceutical industry, with a strong focus onChina NMPA regulations. Proven expertise supportingOSD (tablet, capsule, and related dosage forms)manufacturing operations under NMPA regulations & FDA. Experience preparing facilities for regulatory inspections and managing compliance remediation projects. Strong knowledge of quality systems, validation, data integrity, and pharmaceutical manufacturing best practices. Excellent communication and stakeholder management skills in English, Mandarin is a plus.