Quality Control Team Member

Overview

This position involves preparing, updating, and reviewing pivotal documents such as specifications, SOPs, policies, and operating procedures related to material analysis to ensure compliance with established quality standards, pharmacopeial norms, and current Good Manufacturing Practices (cGMP).

Key Responsibilities

• Develop and revise corporate documents including SOPs and general analytical methods through coordination with QC and QA teams.
• Analyze and incorporate updates from applicable pharmacopoeias and regulatory guidelines into quality documentation.
• Review instrument calibration data in relation to operational documents for accuracy.
• Monitor pharmacopeial amendments and supplements, ensuring timely document updates to maintain regulatory compliance.
• Notify relevant stakeholders to initiate updates prior to effective dates of new pharmacopoeial standards and escalate non-conformities promptly to prevent operational delays.
• Ensure compliance of assigned documents by cross-referencing backup materials and quality procedures, following company policies and SOPs rigorously.
• Maintain issuance records for key documents and bound books, ensuring current versions are accessible throughout various units.
• Drive harmonization and simplification efforts for documentation to reduce complexity and establish standardized processes across multiple units.
• Coordinate with cross-functional teams (CFTs) to gather requirements and suggest process improvements for workflow efficiency.
• Manage challenges such as delays in data availability, shifting priorities, and review timelines through effective coordination, planning, and persistent follow-ups.

Interactions and Scope

• Collaborate daily with CDC, QC, QA, and Regulatory Affairs for document approvals.
• Engage with R&D and IPD departments as needed to source data for documentation updates and new projects.
• Support four units with document updates, preparing and reviewing approximately ten documents per month.
• Achieve at least 80% document finalization within designated timeframes and ensure full implementation of pharmacopoeial updates upon data validation.

Education and Experience

Applicants should hold an M.Sc. or B.Pharm degree, accompanied by 1 to 3 years of experience in pharmaceutical QC departments with a solid understanding of current regulatory and compliance standards.