Urgent opening For QA-QMS (Injectable MFG Prefer)

Intas; Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Intas in Ahmedabad specializes in injectable medicines and maintains rigorous QA/QMS standards across manufacturing and quality control. The role leads audits, CAPA, change controls, and risk assessments to ensure compliance with GMP/GLP/GCP and ISO guidelines.

The ideal candidate holds B.Pharm or M.Pharm with 5–10 years in injectables QA-QMS, and can train staff while collaborating with cross-functional teams to sustain product quality and regulatory readiness.

Qualifications

• Bachelor's or Master's degree in Pharmacy from a recognized institution.
• 5–10 years of injectables manufacturing experience with expertise in QA-QMS functions.
• Strong understanding of GMP/GLP/GCP and ISO standards; familiarity with USFDA/EU GMP guidelines is an added advantage.

Responsibilities

• Ensure compliance with regulatory requirements, company policies, and procedures related to QA/QMS.
• Conduct audits, inspections, investigations, and reviews to identify areas for improvement in manufacturing processes.
• Develop and implement corrective action plans to address non-conformities found during audits or inspections.
• Collaborate with cross-functional teams to ensure effective implementation of change controls, deviation management, and risk assessments.
• Provide training on QA/QMS principles and best practices to employees at all levels within the organization.

Skills

QA/QMS

Audits

Inspections

CAPA / Corrective actions

Change controls

Deviation management

Risk assessment

Training & mentorship

Education

B.Pharm

M.Pharm

Job description

Roles and Responsibilities

• Ensure compliance with regulatory requirements, company policies, and procedures related to Quality Assurance (QA) and Quality Management System (QMS).
• Conduct audits, inspections, investigations, and reviews to identify areas for improvement in manufacturing processes.
• Develop and implement corrective actions plans to address non-conformities found during audits or inspections.
• Collaborate with cross-functional teams to ensure effective implementation of change controls, deviation management, and risk assessments.
• Provide training on QA/QMS principles and best practices to employees at all levels within the organization.

• Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution.
• Minimum 5-10 years of experience in injectables manufacturing industry with expertise in QA-QMS functions.
• Strong understanding of regulations such as GMP/GLP/GCP/ISO standards; knowledge of relevant laws like USFDA/EU GMP guidelines an added advantage.