Sr. Executive / Executive - Quality Assurance

Ipca; Munger; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Ipca in India is seeking a Quality Assurance professional to oversee QA activities for API and Intermediate manufacturing, ensuring GMP compliance and regulatory adherence. You will review records, support batch release, and contribute to continuous quality improvements.

Responsibilities include managing CAPA and deviations, audits, training, equipment qualification, and documentation, while coordinating with contract manufacturers to uphold pharmacopoeia standards and regulatory expectations.

Responsibilities

• Managed Quality Assurance activities for API and Intermediate manufacturing in compliance with GMP and regulatory requirements.
• Led investigations of deviations, OOS/OOT results, quality complaints, CAPA, and change control to ensure product quality and compliance.
• Reviewed batch manufacturing records, laboratory records, specifications, SOPs, validation/qualification protocols, and quality-related documentation prior to batch release.
• Performed batch release of APIs/Intermediates and supported Product Quality Review (PQR), Quality Risk Assessment (QRA), and stability program activities.
• Coordinated internal audits (self-inspections), GMP training programs, and ensured training compliance across departments.
• Oversaw equipment qualification (DQ, IQ, OQ, PQ), validation lifecycle, and documentation including Quality Manual, Site Master File, and Validation Master Plan.
• Ensured analytical methods and quality control specifications complied with current pharmacopoeia standards and customer requirements while monitoring contract manufacturers.
• Issued quality alerts, managed quality documentation, and collaborated with cross-functional teams to drive continuous quality improvement and regulatory compliance.

Job description

Key Responsibilities

• Managed Quality Assurance activities for API and Intermediate manufacturing in compliance with GMP and regulatory requirements.
• Led investigations of deviations, OOS/OOT results, quality complaints, CAPA, and change control to ensure product quality and compliance.
• Reviewed batch manufacturing records, laboratory records, specifications, SOPs, validation/qualification protocols, and quality-related documentation prior to batch release.
• Performed batch release of APIs/Intermediates and supported Product Quality Review (PQR), Quality Risk Assessment (QRA), and stability program activities.
• Coordinated internal audits (self-inspections), GMP training programs, and ensured training compliance across departments.
• Oversaw equipment qualification (DQ, IQ, OQ, PQ), validation lifecycle, and documentation including Quality Manual, Site Master File, and Validation Master Plan.
• Ensured analytical methods and quality control specifications complied with current pharmacopoeia standards and customer requirements while monitoring contract manufacturers.
• Issued quality alerts, managed quality documentation, and collaborated with cross-functional teams to drive continuous quality improvement and regulatory compliance.