క్వాలిటీ అనలిస్ట్

In Pharma, QA is the backbone of GMP compliance. QA does not test the product, QA ensures the _system_ that makes the product is always compliant.

Here are the core duties of QA Department:

*1. Quality Management System (QMS)*

- Preparation, review, approval and control of all GMP documents - SOPs, BMR/BPR, Specifications, STPs

- Document control and archival

- Handling of QMS elements: Deviation, Change Control, CAPA, OOS/OOT, Market Complaint, Product Recall, Risk Assessment (QRM)

*2. Manufacturing & Shopfloor Oversight*

- Line clearance, in-process checks, and IPC monitoring

- Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR)

- Issuance of Batch Numbers and control of status labels

*3. Validation & Qualification*

- Approval of Validation Master Plan (VMP)

- Review and approval of protocols and reports for: Process Validation, Cleaning Validation, Equipment/Utility Qualification (DQ, IQ, OQ, PQ), Computer System Validation (CSV)

*4. Quality Control Oversight*

- Not doing testing, but ensuring QC follows cGMP

- Review and approval of specifications, methods, and analytical method validation

*5. Batch Release*

- Final review of all batch documents

- Batch release/rejection decision with Qualified Person / Authorized Person

- Certificate of Analysis (CoA) approval

*6. Audits & Compliance*

- Self-inspection / Internal audits

- Vendor qualification and supplier audits

- Handling regulatory audits - USFDA, WHO-GMP, EU-GMP, Schedule M

- Ensuring compliance with ICH, 21 CFR Part 211, Schedule M

*7. Training*

- Planning and maintaining cGMP training for all departments

- Training effectiveness evaluation and training records

*8. Other Key Responsibilities*

- Annual Product Quality Review (APQR / PQR)

- Handling of returned goods and product recalls

- Approval of artwork, labels, and packaging materials

- Stability management oversight

- Issuance and control of logbooks

In short:

> *QC = Testing the product*

> *QA = Assuring the system that makes the product is right*

Do you want me to share duties as per:

1. For a QA Fresher interview, or

2. For making a QA SOP / Job Description for your company?

• It is a Full Time తయారీ job for candidates with 5 - 6+ years Experience.