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.
Updates and maintains Quality Assurance Operations logs and databases and generating metrics as needed
Follow up the registration requirements (samples, certificates, specifications, methods of analysis) for the registration department.
Creation, update & issue batch records required for production ? Filling & Packaging.
Prepare periodic summaries of document and record control activities, including the analysis of the types of changed documents, change order cycle times.
Responsible for Preparation, Review, Control and Revision of Standard Operating Procedure.
Preparation, Review and Control of Formats and all documents.
Responsible for training program.
Responsible for Preparation, Review, Control and Revision of head files Like (Site Master File, Quality Manual).
Responsible for Preparation, Review, Control and Revision of Analysis Worksheets.
Responsible for Preparation, Review, Approval, Control and Revision of Specifications and Standard Test Procedures.
Participates in internal audits and supporting external audits
Responsible for Batch Release process.
Responsible for reconciliation of documents.
Responsible for batch record revision after retrieval from production
