Job highlights
- 15-18 years experience in Pharmaceutical Quality Assurance with expertise in GMP compliance, QMS, validation, and audit management
- Manage QMS, conduct audits, review validation documents, batch release, vendor qualification, and ensure regulatory compliance
Dear All, Greetings from Aizant Drug Research Solutions!!!
We have a requirement for Quality Assurance team at our Manufacturing unit located at Hyderabad(Dulapally).
Experience: 15-18 Years
Job Purpose:
Responsible for ensuring GMP compliance, QA systems, documentation control, validation, audit management, batch release, vendor quality management, and regulatory compliance in line with company and customer requirements.
Key Responsibilities:
- Manage Quality Management Systems (QMS), SOPs, Change Controls, Deviations, CAPAs, Incidents, and documentation.
- Conduct and coordinate internal, vendor, client, and regulatory audits and ensure timely closure of observations.
- Review and approve validation and qualification documents (VMP, CSV, DQ/IQ/OQ/PQ, process and cleaning validation).
- Review and release batches, BMR/BPR, product specifications, STPs, and APQRs.
- Provide QA oversight for investigations, Data Integrity, Risk Assessments, CAPAs, and Change Controls.
- Support vendor qualification, quality agreements, and client quality-related activities.
- Review artwork, material codes, and quality-related documentation.
- Drive continuous improvement initiatives and ensure compliance with GMP, regulatory, and customer requirements.
Required Skills:
- Quality Assurance
- GMP Compliance
- QMS, CAPA, Deviations, Change Controls
- Validation & Qualification
- Batch Release
- Audit & Inspection Management
- Data Integrity
- Vendor Qualification
- Pharmaceutical Manufacturing
- Relevant experience in Pharmaceutical Quality Assurance and GMP-regulated manufacturing setting.
Note: Interested candidates can share the profile to
[email protected]
📌 Senior Manager/AGM-Quality Assurance(Formulations) (Hyderabad)
🏢 Aizant
📍 Hyderabad