Job Description

The QA Executive is responsible for supporting the implementation and maintenance of the site's Quality Management System (QMS) to ensure that all manufacturing, testing, storage, and distribution activities comply with internal procedures, cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), and applicable national/international regulatory guidelines.

Key Responsibilities and Duties1. Documentation and QMS Management

1. Documentation and QMS Management

SOPs and Master Documents:

Draft, review, and revise Standard Operating Procedures (SOPs), Work Instructions, Master Batch Records (MBRs), and Master Packaging Records (MPRs).

Batch Record Review and Product Disposition:

Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs), Quality Control (QC) data, and associated documentation for completeness and compliance before recommending

batch release or rejection

of Finished Products, Intermediates, and Raw/Packaging Materials.

Document Control:

Manage the issuance, retrieval, and archiving of controlled documents and records to ensure data integrity and traceability.

2. Deviation, CAPA, and Change Control

Deviation Management:

Initiate, investigate, and coordinate the investigation of quality deviations, non-conformances, and incidents (e.g., OOS/OOT). Use root cause analysis tools (e.g., 5 Whys, Fishbone Diagram) and propose effective corrective actions.

CAPA (Corrective and Preventive Actions):

Develop, track, and ensure the timely and effective implementation and closure of CAPAs to prevent recurrence.

Change Control:

Review and approve change control requests (CCR) for impact assessment on product quality, validation status, and regulatory compliance before implementation.

3. Compliance and Auditing

Internal and External Audits:

Participate in and conduct scheduled

internal audits

of various departments (Production, QC, Warehouse, Engineering) to verify cGMP compliance.

Inspection Readiness:

Support regulatory inspections (e.g., FDA, MHRA, WHO) and customer audits, including preparation, hosting, and ensuring timely submission of responses and follow-up actions.

Supplier/Vendor Management:

Participate in the qualification and re-evaluation of critical suppliers and vendors, which may include conducting

supplier audits

.

4. Validation and Qualification

Review and approve documents related to equipment

Qualification

(IQ, OQ, PQ) and process/cleaning

Validation

protocols and reports to ensure consistent performance and regulatory compliance.

5. Training and Continuous Improvement

Assist in developing and delivering

cGMP and quality-related training

programs to plant personnel. Contribute to the compilation and review of the

Annual Product Quality Review (APQR)

data.
Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹25,000.00 per month

Benefits:

Cell phone reimbursement Internet reimbursement
Work Location: In person