Analytical Lab QA-Executive

Authorized, Responsible and accountable for

1. Analytical check in QC

• To Conduct In process Quality Assurance check for the Quality Control and follow up for the Corrective Actions.
• Review in process, finished product ADS and FP COA.
• Review and release of raw material and affixing of the the labels.
• Microbiology In process checks, review of water trends, EM trends.
• Chemistry water trends.
• Stability Protocol and report review.
• Regular monitoring of Stability and issuance of ADS.
• Back up review of Stability data.
• Review of protocols and reports and follow up for the closure.
• OOS, LIR, OOL & OOT Handling as per respective SOP.
• Audit Trial review

1. SOPs/STPs/Specs:

• Preparation and review of SOPs for QA department,
• Review of other departments SOPs for correctness.
• Review of STPs and specifications.

1. Documentation Room:

• Segregation of documents as per displayed room. And update the list of documents on regular basis.

1. GMP and GLP compliance:

• Maintain GMP and GLP compliance in Quality Control.

1. Labelling:

• Maintaining centralized label control.

1. APQR:

• Compilation of data.
• Preparation and Closure of APQR.

1. QRM

• Assigning the risk assessment number as per requirement.
• Preparation and review of the risk assessment.

1. Audit and Compliance:

• Compliance to the external audits and internal gaps.
• Preparation for external and internal audits.
• Responsible for overall QA compliance activity.

1. Co-ordination with RA for document sharing.
2. Effective Co- ordination with inter and intra Department for carrying Trouble free operation.
3. Responsible to follow cGMP & GDP for documentation.
4. Perform task and activities assigned by HOD whenever required.
5. Focus on QCD to establish effective process and systems for improving quality and reducing cost of Manufacturing.
6. Review of the water system related documents.
7. Computer system validation activity.
8. Vendor Qualification activity.
9. Preparation of controlled copy, uncontrolled copy and other copy as per the requirement and issue to the concern department / personnel
10. Maintaining the soft copy of the document in the QA folder.
11. Control of SOPs and Quality Documents.
12. Issuance and retrieval of documents