Quality Assurance Senior Specialist (Documentation)

Job Description

Job Purpose:

• Maintain an efficient and easily retrievable documentation system for all the documents of the factory according to the quality management system (QMS).

Job duties & Responsibilities:

• Develop procedures to ensure that Quality System documents are originated, changed, reviewed, distributed, archived and periodically reviewed using systems that are efficient and meet all regulatory requirements.
• Develop and maintains systems that effectively archive and retrieve quality records assigned to the Document Control, including external standards, technical reports, etc.
• Ensure that the Document Control systems used at all company sites are harmonized where appropriate.
• Follow-up filling & packaging inkjet data, analysis results and release batches on Oracle system for Exportation invoices.
• Follow up the exportation registration requirements (samples, certificates, specifications, methods of analysis and letters) for the exportation department.
• Responsible for the department administrative requirements and purchasing cycle.
• Organize and coordinate with the external audit authorization to proceed and follow surveillance and recertification audits.
• Determine weighing of Toll Manufacturing products for filling process.
• Follow up issued filling & packaging daily plan.
• Creation, update & issue batch records required for production – Filling & Packaging.
• Creation, update & issue batch records required for production – Mixing – for toll manufacturing products.
• Follow up toll manufacturing requirements and documents.
• Prepare periodic summaries of document and record control activities, including the analysis of the types of changed documents, change order cycle times.