Executive Quality Assurance

2 weeks ago

Baddi, India Abbott Laboratories Full time

**Sr. Executive IPQA**

**M. Pharma/ B. Pharma/M.Sc.**

**Minimum 6 Years’ Experience in solid dosage form
- Tablets. Person shall be well versed with manufacturing and packaging operations, Compression Machines, Isolators, Blenders, Bulk packing lines, Investigation, QRM & Process Validation.**

**Person with Experience in Hormone Facility shall be preferred.**

**Followings will be the responsibilities of the position holder**:
Ensure compliance to cGMP Regulations, established SOPs, FO/MI and PO/PI and for all operational activities, area and equipment.
Perform QA review of executed batch production records and ensure the submission of Batch production record in the document cell.
Calibration & maintaining documentation of In-process Quality Assurance (IPQA) instruments.
Data back-up activities of IPQA instruments as per defined SOP frequency.
Monitor the environmental conditions mentioned in the batch production record and SOP.
Certification of batch production records for compliance and stage-wise compliance.
Reporting any GMP related discrepancies, non-conformances and deviations to superiors immediately.
Collection and entry of data for APR preparation.

**Line Clearance**:
Ensure physically that the area and equipment to be used for manufacturing and packaging of next product/batch are free from any material/remnants of previous product.

Ensure to prevent mix up and cross contamination.
Check for proper environmental conditions with respect to temperature, Relative humidity, differential pressure etc.
Ensure that the Batch Production record is completed up to the previous stage.
Verify the material with respect to the container labels and quantity from the batch production record.

**In-Process Checks**:
Ensure the calibration of instruments for in-process checks.
In-process checks as per the approved manufacturing and packaging instructions.
Enclose all the printouts generated during in-process checks along with the batch production record.
All printouts shall be duly signed after checking.
Inform the production manager, supervisor and quality assurance manager about the in-process failure observed during in-process checks.
To record all the observations in the Batch Production Record

**Inspection**:
Inspection of the Tablets/Capsules as per SOP.
Inspection of the Finished Goods as per SOP and clearance of Transfer Ticket by ensuring the quantity and batch details.

**Sampling**:
Ensure for usage of appropriate sampling tool for sampling.
Ensure sampling device cleaning prior to the sampling.
Sampling procedure to be followed as per SOP No. SOP019995 (Sampling of intermediates, finished product and stability samples) & SOP020059 (Collection and shipment of Analytical samples of EU market).
Ensure sampling of in-process finished product, process validation, cleaning validation, control samples, EU Lab testing samples & stability samples, Reference & Retention sample as per SOP.

**Approval**:
Approval of coding pattern on immediate pack and secondary pack to be verified as per the approved packaging instructions / written procedures. Investigation of non-conformance, market complaint. Root cause analysis and CAPA. To prepare and update all master document list as per requirement. To initiate change control/document amendment for any change or improvement in the process.
Review of BMR/BPR, APQR and QMS Documents Responsible for Self-Inspection. Responsible for Annual product Quality Review. Qualification of service providers. Review of artwork. Review of RM/PM & Finished product specification

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