Sr. Manager - QA (API Pharma)

Mangalam Drugs & Organics; Vapi; On-site; INR 2,800,000 - 3,800,000; Full time

Job summary

Mangalam Drugs & Organics is seeking an experienced Sr Manager - QA for our API manufacturing unit in VAPI. The role requires a minimum of 15 years in QA, with at least 5+ years in a Site QA Head capacity, leading a team of about 25 staff to ensure site quality and regulatory compliance.

The incumbent will oversee the Quality Assurance function, drive CAPA, handle market complaints, and coordinate audits while ensuring robust SOP development and adherence to GMP standards.

Qualifications

• Minimum 15 years of experience in QA domain.
• At least 5+ years in a Site QA Head role.
• Experience in API manufacturing is preferred.
• Experience leading a team of ~25 staff.

Responsibilities

• Oversee and manage the Quality Assurance function at the site.
• Ensure implementation and compliance with GMP and regulatory standards.
• Lead CAPA (Corrective and Preventive Actions) processes.
• Handle Market Complaints and ensure effective resolutions.
• Manage Change Control, Deviation Management, and APQR processes.
• Prepare and review Standard Operating Procedures (SOPs).
• Lead and coordinate with internal teams for customer and regulatory audits.

Skills

Quality Assurance

GMP

CAPA

Audit management

Regulatory compliance

Job description

We are looking for an experienced Sr Manager - QA for our API manufacturing unit in VAPI. The ideal candidate should have a minimum of 15 years of experience, with at least 5+ years in a Site QA Head role. This role will be responsible for managing the Quality Assurance functions at the site and leading a team of 25 staff members.

Key Responsibilities:

• Oversee and manage the Quality Assurance function at the site
• Ensure implementation and compliance with GMP and regulatory standards
• Lead and manage CAPA (Corrective and Preventive Actions) processes
• Handle Market Complaints and ensure effective resolutions
• Manage Change Control, Deviation Management, and APQR (Annual Product Quality Review) processes
• Prepare and review Standard Operating Procedures (SOPs)
• Lead and coordinate with internal teams for customer and regulatory audits