Senior Manager/AGM-Quality Assurance(Formulations)

Aizant Drug Research Solutions Pvt. Ltd.; Hyderabad; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Aizant Drug Research Solutions Pvt. Ltd. in Hyderabad invites an experienced Quality Assurance professional to ensure GMP compliance across manufacturing operations. You will lead QA systems, document control, audits, validation activities, batch release, and vendor quality management, driving continuous improvement.

Ideal candidate has 15–18 years in pharmaceutical QA, with strong knowledge of QMS, CAPA, data integrity, and regulatory requirements.

Qualifications

• Experience in Pharmaceutical Quality Assurance in GMP-regulated manufacturing environments.
• Strong understanding of QMS, CAPA, deviations, changes controls, and documentation compliance.
• Proven track record in batch release, audits, and vendor quality management.

Responsibilities

• Manage 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/qualification documents (VMP, CSV, DQ/IQ/OQ/PQ, process and cleaning validation).
• Review and release batches, BMR/BPR, product specs, 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 and ensure GMP/compliance with regulatory/customer requirements.

Skills

Quality Assurance

GMP Compliance

QMS

CAPA

Deviations

Validation

Batch Release

Audit & Inspection

Data Integrity

Vendor Qualification

Pharma Manufacturing

GMP-regulated

Job description

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 environment.