- 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.
- Responsible for Batch Release process.
- Responsible for reconciliation of documents.
- Responsible for batch record revision after retrieval from production.
- Participates in internal audits and supporting external audits
Bachelor of pharmacy or science.Proven work experience as a Documentation Specialist or similar roleStrong analytical and critical thinking skillsExcellent verbal and written communication skillsDocumenting and reporting skillsComputer knowledgeGood English languageProficiency in MS Office (MS Excel & word)