The role is responsible for managing QC samples, records, and Certificates of Analysis while ensuring strict adherence to Good Manufacturing Practice regulations
Job Summary
The role is responsible for managing QC samples, records, and Certificates of Analysis while ensuring strict adherence to Good Manufacturing Practice regulations.
Candidates must draft management procedures for stability studies, reagents, and precursor chemicals while maintaining data integrity according to ALCOA+ requirements.
The position involves leading abnormality investigations, managing outsourced testing contracts, and participating in internal and external audits to ensure compliance.
Matching Summary
The role is responsible for managing QC samples, records, and Certificates of Analysis while ensuring strict adherence to Good Manufacturing Practice regulations.
Skills & Requirements
Must-have
QC sample management procedures
Certificate of Analysis issuance
Stability study plan execution
GMP compliance adherence
Data integrity ALCOA+ standards
Reagent and reference standard management
Nice-to-have
Strong organizational capabilities
Effective cross-team communication
English language proficiency
Microsoft software proficiency
Audit participation experience
Key Requirements
Bachelor's degree in Pharmacy or related field
Minimum three years pharmaceutical quality experience
Familiarity with national pharmacopoeias and GMP guidelines