Title:  Officer - QC

Experience: 3+ years

Qualification: MSc

1. Approval authority:

1. Extra page issuance form.
2. Batch internal release certificate and transfer note.
3. Breakdown memo perform impact analysis on product quality and sign for QA.
4. Tool set checking record.
5. Release of bulk product for further stage.

2. Key execution support for on-the-floor QA activities.

3. Witness key operation steps:

1. Area cleanliness and Cleaning Schedules.
2. Equipment cleanliness.
3. Start-up Activities.
4. Cleaning Documentation.

4. Verify key activities:

1. Monitor GMP and compliance activities:
   • Clean equipment.
   • Equipment cleaning and use logs.
   • Documentation practices.
   • Labelling practices throughout operations.
   • First coded approvals
2. Reporting of Internal quality observations.
3. Reporting of incidents.
4. Bulk batch approval to proceed.
5. Follow-up on open investigations, CAPA and audit observations.

TASKS

1. Follow procedures for area QA oversight.
2. Collection and transfer of samples (completion of test request) as per approved batch record or protocol.

1. Verification of the sampling instrument cleanliness.

3. Perform in-process checks or verifications as required in QA approved batch records or protocols.
4. Reviewing of the batch manufacturing record for its completeness and reporting of   the BMR observation.
5.  Direct support during key production activities:

1. Process validation execution, including raw data checks and report preparation.
2. Characterization batches.
3. Various other approved protocols.

6. Preparation and trending of key process information and/or reports in support of protocols, CPV, incidents or CAPA follow-up.
7. Supporting operations in assisting or providing and documenting training when Required.
8. Suggest improvements to reduce chance for errors.