Manager-Quality Assurance(Formulations)

Aizant Drug Research Solutions Pvt. Ltd.; Hyderabad; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Aizant Drug Research Solutions Pvt. Ltd. in Hyderabad seeks a senior Quality Assurance professional with 15-18 years in pharmaceutical QA to ensure GMP compliance, robust QA systems, and strict documentation control.

You will oversee validation, audits, batch release, vendor quality management, and regulatory adherence, guiding continuous improvement across operations. Responsibilities include managing QMS, CAPAs, deviations, change controls, incidents, and vendor qualifications while ensuring

Qualifications

• Experience: 15-18 years in Pharmaceutical Quality Assurance.
• Role focuses on GMP compliance, QA systems, documentation control, validation, audit management, batch release, vendor quality management, and regulatory compliance.

Responsibilities

• Manage QMS, SOPs, Change Controls, Deviations, CAPAs, Incidents, and documentation.
• Coordinate internal, vendor, client, and regulatory audits with timely closure of observations.
• Review and approve validation documents (VMP, CSV, DQ/IQ/OQ/PQ) and related filings.
• Review and release batches, BMR/BPR, product specs and APQRs.
• Provide QA oversight for investigations, Data Integrity, risk assessments, CAPAs, and Change Controls.
• Support vendor qualification, quality agreements, and client quality activities.
• Review artwork, material codes, and quality-related documentation.
• Drive continuous improvement to ensure GMP and regulatory compliance.

Skills

Quality Assurance

GMP Compliance

QMS

CAPA

Deviations

Change Controls

Validation

Qualification

Batch Release

Audit Management

Data Integrity

Vendor Qualification

Pharmaceutical Manufacturing

Regulatory Compliance

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.