DQA - Manager

Aurore Life Sciences Pvt Ltd; Shapur Nagar; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Aurore Life Sciences Pvt Ltd is seeking a DQA Manager to lead the Quality Assurance function and ensure GMP compliance across API manufacturing. The role reports to Head - Quality / Plant Head and demands strong leadership and regulatory acumen.

The position focuses on maintaining quality systems, conducting audits, and driving continuous improvement through CAPA, deviations, and change controls, with cross-functional collaboration across departments.

Qualifications

• Minimum 12–15 years of QA experience in API/pharma industry.
• At least 4–6 years in a managerial role.
• Strong knowledge of GMP and regulatory guidelines.

Responsibilities

• Lead QA department and quality systems to ensure GMP compliance.
• Oversee internal and vendor audits and regulatory inspections.
• Review SOPs, specs, protocols, and batch release docs.
• Drive CAPA, deviations, change controls, and risk assessments.
• Coordinate with Production, QC, Regulatory Affairs, and other departments.
• Train and develop QA team on regulatory requirements.

Skills

GMP Knowledge

Regulatory Compliance

CAPA

Deviations & Investigations

Change Controls

Leadership

Documentation

QMS

Audits & Inspections

Cross-functional Coordination

Education

M.Sc./M.Pharm/B.Pharm

Job description

Job Description (JD) DQA Manager (Data Quality Assurance / Quality Assurance Manager)

Position: DQA Manager
Department: Quality Assurance (QA)
Reporting To: Head - Quality / Plant Head
Location: Hyderabad (or as applicable)

Role Purpose

To lead and manage all Quality Assurance activities, ensuring compliance with GMP, regulatory requirements, quality systems, and customer expectations. Responsible for maintaining quality standards across manufacturing, documentation, validation, audits, and regulatory inspections.

Key Responsibilities

• Manage and oversee the Quality Assurance department and quality systems.
• Ensure compliance with cGMP, ICH, WHO, USFDA, MHRA, EU GMP, and other applicable regulatory guidelines.
• Review and approve SOPs, specifications, protocols, reports, and quality-related documents.
• Monitor deviations, OOS (Out of Specification), OOT (Out of Trend), CAPA, change controls, and risk assessments.
• Lead internal audits, vendor audits, and support regulatory inspections.
• Review batch manufacturing records and batch release documentation.
• Ensure qualification and validation activities are completed as per regulatory requirements.
• Drive continuous improvement initiatives for quality systems and compliance.
• Conduct quality review meetings and provide management reports.
• Train and develop QA team members on quality systems and regulatory requirements.
• Coordinate with Production, QC, Warehouse, Regulatory Affairs, and other departments.

Qualification

• M.Sc. / M.Pharm / B.Pharm or equivalent qualification.

Experience

• 12 to 15 years of experience in Quality Assurance within the API/Pharmaceutical industry.
• Minimum 4 to 6 years of experience in a managerial role.

Skills Required

• Strong knowledge of GMP and regulatory compliance.
• Experience handling regulatory audits and customer inspections.
• Expertise in CAPA, deviations, change controls, and quality investigations.
• Good leadership, team management, and communication skills.
• Strong documentation and analytical skills.
• Proficiency in quality management systems and regulatory guidelines.

Key Competencies

• Leadership & People Management
• Quality Compliance
• Decision Making
• Problem Solving
• Risk Management
• Cross-functional Coordination