- Issue batch production record.
- Issue and Retrieval of cleaning records.
- Review of batch production and equipment cleaning records.
- Documentation systems issue and control of documents.
- Upkeep of documentation.
- Issue of certificates photocopies to the user departments, with draw of obsolete copies and issue of uncontrolled copies whenever required.
- Checking the certificate of analysis prepared by quality control.
VALIDATION:
- Reviewing of equipment qualification & other documents.
- Reviewing of Engineering related documents.
- Preparation of Risk Assessment
- Preparation of validation protocol
- Supporting of customer / regulatory audits.
- Trending of Manufacturing norms, Quality Parameter, Microbial count Monitoring & Water trend.
- Preparation of monthly report.
- Review the Change control with impact assessment of all changes.
- Preparation of Annual product quality review (APQR).
- Upkeep of documentation.
- Document/Format Issuance and Retrieval
- Preparation of Standard Operating Procedure