Executive

Sssv Solutions Visakhapatnam; Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

API Pharma in Hyderabad is seeking an Executive QA (IPQA & AQA) with 3–7 years in QA to perform IPQA on the shop floor, conduct line clearance, and ensure compliance with cGMP, GDP, and SOPs.

You will review BMR/BPR, manage deviations, CAPAs, change controls, and investigations, and coordinate with Production, QA, QC. Strong documentation and cross-functional collaboration are essential.

Qualifications

• 3–7 years of QA experience in API pharma.
• Hands-on IPQA/shop-floor activities and QA documentation.
• Strong knowledge of cGMP, GDP, SOPs, deviations, CAPA, change control, investigations, and audits.

Responsibilities

• Perform IPQA activities on the shop floor in API manufacturing areas.
• Conduct line clearance, in-process checks, area clearance, and batch documentation review.
• Ensure compliance with cGMP, GDP, SOPs, and quality standards throughout manufacturing operations.
• Review and verify Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and other GMP documents.
• Handle and support deviation, CAPA, change control, and investigation activities.
• Prepare, review, and maintain quality-related documentation in compliance with regulatory requirements.
• Coordinate with Production, QA, QC, and other cross-functional teams during manufacturing and quality activities.
• Support preparation and review of APQR/PQR.

Skills

IPQA

AQA

In-Process QA

Line Clearance

Deviation Handling

CAPA & Change Control

GMP Compliance

Documentation

Job description

Executive QA (IPQA & AQA) | API Pharma | Hyderabad

Position: Executive QA (IPQA & AQA)
Experience: 37 Years
Industry: API Pharma - Mandatory
Location: Hyderabad

Role & Responsibilities

• Perform IPQA activities on the shop floor in API manufacturing areas.
• Conduct line clearance, in-process checks, area clearance, and batch documentation review.
• Ensure compliance with cGMP, GDP, SOPs, and quality standards throughout manufacturing operations.
• Review and verify Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and other GMP documents.
• Handle and support deviation, CAPA, change control, and investigation activities.
• Prepare, review, and maintain quality-related documentation in compliance with regulatory requirements.
• Coordinate with Production, QA, QC, and other cross-functional teams during manufacturing and quality activities.
• Support preparation and review of Annual Product Quality Review (APQR/PQR).
• Perform SOP review, document control, and periodic review of quality documents.
• Ensure timely closure and effective implementation of deviations, CAPAs, change controls, and investigations.
• Support internal, customer, and regulatory audits and ensure compliance with audit requirements.
• Monitor adherence to GMP and regulatory requirements across manufacturing and quality processes.
• Identify quality and compliance gaps and coordinate with relevant departments for appropriate corrective and preventive actions.
• Maintain accurate and complete QA records and documentation as per approved procedures.

Key Skills:

API Pharma | QA | IPQA | AQA | In-Process Quality Assurance | APQR | PQR | cGMP | GDP | SOP | Batch Records | BMR | BPR | Line Clearance | Deviation | CAPA | Change Control | Investigation | Document Control | Audit Compliance | Regulatory Compliance

Candidate Profile

• 3-7 years of relevant experience in Quality Assurance within the API Pharma industry.
• Hands-on experience in IPQA/shop floor activities and QA documentation.
• Good knowledge of cGMP, GDP, SOPs, deviations, CAPA, change control, investigations, and audits.
• Candidates with exposure to both IPQA and AQA/Quality Systems activities will be preferred.
• Good documentation, communication, coordination, and analytical skills.