QA/QC Specialist (Analytical Method Validation)

Details of the job responsibilities to be performed

We are seeking a detail-oriented and experienced QC Documentation Specialist to join our Quality Control team. The candidate will be responsible for creating, preparing, and maintaining high-quality documentation to ensure compliance with regulatory standards and company policies. This includes authoring protocols and reports for Analytical Method Transfer (AMT), Analytical Method Validation (AMV), product specifications, and standard testing procedures for finished products.

• Create and prepare AMT protocols, worksheets, and reports to facilitate the efficient transfer of analytical methods between sites or laboratories.
• Develop detailed AMV protocols and reports to validate analytical methods in accordance with regulatory guidelines.
• Draft and maintain precise product specifications, ensuring compliance with regulatory requirements.
• Author and review Standard Testing Procedures (STPs) for finished products intended for routine use.
• Verify reagents, chemicals, and reference standards per the STP, and initiate purchase requisitions as needed through the ERP system.
• Perform HPLC processing and reporting for SCIOM analysis.
• Conduct Excel validations in alignment with the Internal Procedure.
• Ensure all documentation complies with Good Manufacturing Practices (GMP) and other applicable regulatory standards.
• Periodically review QC documentation to ensure consistency, accuracy, and relevance.
• Collaborate with cross-functional teams to resolve documentation gaps and implement corrective measures.
• Work closely with laboratory analysts, QC leads, and other stakeholders to gather the required information for documentation.
• Ensure proper creation and maintenance of documentation, including SOPs, validation protocols, and change control records.
• Prepare and review Quality Technical Agreements and oversee documentation for outsourced activities.
• Identify opportunities for process improvements and implement changes to enhance overall product quality.
• Any other duties as and when required.