DGM Quality Assurance

Acumen 360 Consulting & HR Solutions; Vadodara; On-site; INR 400,000 - 800,000; Full time

Job summary

Acumen 360 Consulting & HR Solutions in Vadodara seeks a regulatory affairs professional to oversee GMP compliance, documentation, audits, CAPA, product release, and regulatory filings. The role also involves liaising with regulatory agencies and guiding DMF processes within a cross‑functional manufacturing environment.

The candidate will monitor regulatory guidelines, maintain SOPs and batch records, and ensure product quality and compliance across the lifecycle.

Responsibilities

• GMP Compliance: Implement Good Manufacturing Practices (GMP) to ensure product safety and quality throughout the lifecycle.
• Documentation & SOPs: Develop, review, and maintain Standard Operating Procedures (SOPs), batch records, and, in some cases, documentation for approvals or exports.
• Auditing: Conduct internal and external audits of manufacturing facilities.
• CAPA & Deviations: Manage deviations, non-compliance issues, and implement Corrective and Preventive Actions (CAPA).
• Product Release: Ensure products meet required specifications before release.
• Regulatory Filings: Prepare and submit dossiers for new drug applications.
• Compliance Strategy: Monitor and interpret regulatory guidelines to ensure products meet legal standards.
• Liaison: Act as the primary contact between the company and regulatory agencies.
• Will be responsible for DMF process.

Job description

Responsibilities

1. GMP Compliance: Implement Good Manufacturing Practices (GMP) to ensure product safety and quality throughout the lifecycle.
2. Documentation & SOPs: Develop, review, and maintain Standard Operating Procedures (SOPs), batch records, and, in some cases, documentation for approvals or exports.
3. Auditing: Conduct internal and external audits of manufacturing facilities.
4. CAPA & Deviations: Manage deviations, non-compliance issues, and implement Corrective and Preventive Actions (CAPA).
5. Product Release: Ensure products meet required specifications before release.
6. Regulatory Filings: Prepare and submit dossiers for new drug applications.
7. Compliance Strategy: Monitor and interpret regulatory guidelines to ensure products meet legal standards.
8. Liaison: Act as the primary contact between the company and regulatory agencies.
9. Will be responsible for DMF process.