Perform quality assurance support functions by interacting with manufacturing and quality control colleagues regarding quality matters on a daily basis. Assure documentation maintenance as required by Corporate, Regulatory and site procedures and GMP regulations.
Periodically audit site, suppliers, procedures and documentation for adherence to ICH and cGMP regulatory commitments policies/procedures.
Scope of Responsibilities
Note: The following describes the full area of responsibility of the QA Specialist role. Individual QA Specialists may fulfill some or all of these areas of responsibility.
· Ensure all product is manufactured, tested and released in compliance with ICHQ7
· Review and approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing
· Disposition of intermediates and API
· Review and approval of deviations, change controls, SOPs, out of compliances, lab investigations and cleaning batch records.
· Lead internal audits and reviews of manufacturing operations and quality systems to ensure compliance with cGMPs and other regulatory requirements
· Assist with regulatory inspections
· Assist with the development and delivery of cGMP training
· Assure site compliance with CGMPs and Corporate Policies/Procedures.
· Provide Quality Assurance Support for Validation
· Maintain knowledge of regulatory environment, ICH, cGMPS, FDA and EMA
· Policy and current industry trends. Provide technical expertise to colleagues regarding the interpretation and/or implementation of cGMP matters.
· Maintain appropriate EHS standards
Quality Assurance API Batch