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Job Description
- Responsible for Preparation, Review, Control and Revision of Standard Operating Procedure.
- Coordinates the revision and review of SOPs and other GMP documents.
- 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 developing and keeping copies of the required Batch Manufacturing Record (BMR) and Batch Packaging Report (BPR) for production
- Responsible for Batch Release process.
- Responsible for reconciliation of documents.
- Responsible for batch record revision after retrieval from production.
- Responsible for Retrieval, control, retention and destruction of all completed documents.
Job Requirements
- Proven work experience as a Documentation Specialist or similar role
- Outstanding organizational skills
- Multitasking ability
- Attention to detail
- Excellent written and verbal communication
- Relevant training and/or certifications as a Documentation Specialist