- 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.
|
