Executive

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.

INTRESTED CANDIDATES CAN CONTACT:-7995750033