02 Sep
|
Sssv Solutions Visakhapatnam
|
Hyderabad
02 Sep
Sssv Solutions Visakhapatnam
Hyderabad
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.
- Positive 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:-(phone hidden)
📌 Executive (Hyderabad)
🏢 Sssv Solutions Visakhapatnam
📍 Hyderabad