Qualificaition - MSc/MPharma
Experience - 12 + years
- Approval authority:
- Extra page issuance form.
- Batch internal release certificate and transfer note.
- Breakdown memo perform impact analysis on product quality and sign for QA.
- Tool set checking record.
- Release of bulk product for further stage.
- Key execution support for on-the-floor QA activities.
- Witness key operation steps:
- Area cleanliness and Cleaning Schedules.
- Equipment cleanliness.
- Start-up Activities.
- Cleaning Documentation.
- Verify key activities:
- Monitor GMP and compliance activities:
- Clean equipment.
- Equipment cleaning and use logs.
- Documentation practices.
- Labelling practices throughout operations.
- First coded approvals
- Reporting of Internal quality observations.
- Reporting of incidents.
- Bulk batch approval to proceed.
- Follow-up on open investigations, CAPA and audit observations.
TASKS
- Follow procedures for area QA oversight.
- Collection and transfer of samples (completion of test request) as per approved batch record or protocol.
- Verification of the sampling instrument cleanliness.
- Perform in-process checks or verifications as required in QA approved batch records or protocols.
- Reviewing of the batch manufacturing record for its completeness and reporting of the BMR observation.
- Direct support during key production activities:
- Process validation execution, including raw data checks and report preparation.
- Characterization batches.
- Various other approved protocols.
- Preparation and trending of key process information and/or reports in support of protocols, CPV, incidents or CAPA follow-up.
- Supporting operations in assisting or providing and documenting training when Required.
- Suggest improvements to reduce chance for errors.
