Manager-Quality Assurance(Formulations)

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: 12-17 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 environment.

Note: Interested candidates can share the profile to [email removed]