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  • 3 weeks ago

jobs description

ProductLife US is seeking a Quality GMP Auditor to be responsible for auditing drug substance and drug product peptide manufacturers. The Candidate will perform on-site audits in China. The Candidate will work remotely in a team environment on projects as an hourly, Independent Consultant.

• In depth knowledge of Drug Substance/API manufacturing for peptides,
• In depth knowledge of Drug product manufacturing and packaging,
• Good writing and comprehension skills,
• Provide guidance to the client on regulations and requirements for filings,
• Capable of providing guidance on technical and regulatory requirements for the conduct of clinical trials, as well as advice on GxP-issues is a plus,
• Competent problem solving, risk assessment and impact analysis abilities,
• Excellent mentoring experience.

Language Skills

· Must be fluent speaking and have good, written & verbal skills in Mandarin and English.

Required Skills
• B.S. in a scientific discipline or an... equivalent combination of education, training, and experience,
• Experienced GMP auditor with a minimum of 10 years in the pharmaceutical industry,
• Provide determination in written reports to confirm that the active substance and drug product has been manufactured in accordance with GMP standards and the associated filings,
• Perform authorized audits and activities with specific responsibility for GMP compliance
Shanghai China


Apply - Senior Quality Auditor Shanghai