Accountabilities:
- Document Preparation and Support:
- Prepare SOPs, specifications, and non-routine documentation.
- Ensure timely availability of documents across the site to support analysis.
- Pharmacopoeial Compliance:
- Review the latest pharmacopeial updates, supplements, and amendments.
- Evaluate and update available documents to ensure compliance with current pharmacopoeia in consent with regulatory bodies.
- Document Review:
- Review assigned documents referring to the concerned backup and pre-defined quality procedures.
- Ensure compliance against quality requirements.
- Document Issuance:
- Issue documents to applicable units.
- Maintain records of issued documents in the issuance record (bound book) to ensure the current version of common documents is available at the unit.
- Process Harmonization:
- Execute harmonization and simplification processes for documents.
- Reduce complexities in processes and ensure standardized procedures are followed.
