AGM Quality Assurance (API Pharma)

Fact Personnel Private Limited; Tanuku; On-site; INR 5,000,000 - 7,000,000; Full time

Job summary

Fact Personnel Private Limited is seeking a senior Quality Assurance leader with 18-20 years of experience in QA within API/bulk drug manufacturing. The candidate should have proven experience heading the QA department and strong knowledge of pharmaceutical quality systems, cGMP, and regulatory compliance.

The role involves overseeing audits, inspections, deviations, CAPA, change control, investigations, and building high-performing teams to ensure product quality and compliance across

Qualifications

• 18-20 years of experience in QA within API/bulk drug manufacturing.
• Proven experience heading the QA department.
• Strong knowledge of pharmaceutical quality systems, cGMP, regulatory compliance, and quality management.
• Experience in handling audits, inspections, deviations, CAPA, change control, and investigations.
• Strong team management and leadership skills.
• Experience in API manufacturing is mandatory.

Responsibilities

• Head the Quality Assurance department and ensure QA leadership across the organization.
• Maintain compliance with cGMP and regulatory requirements.
• Oversee audits, inspections, deviations, CAPA, change control and investigations.
• Develop and maintain robust pharmaceutical quality systems.
• Lead and develop a high-performing QA team.

Skills

QA leadership

API/Bulk drug QA

cGMP knowledge

Regulatory compliance

Audits & inspections

CAPA & change control

Investigations

Team management

Job description

Role & responsibilities

• 18-20 years of experience in Quality Assurance within API / Bulk Drug manufacturing companies.
• Proven experience in heading the Quality Assurance department.
• Strong knowledge of pharmaceutical quality systems, cGMP, regulatory compliance, and quality management.
• Experience in handling audits, inspections, deviations, CAPA, change control, and investigations.
• Strong team management and leadership skills.
• Experience in API manufacturing is mandatory.