Manufacturing-Documentation Manager

Encube Ethicals Limited; South Goa District, North Goa; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Encube Ethicals Limited in Goa is seeking an experienced professional to lead and manage manufacturing documentation and compliance activities, ensuring adherence to cGMP standards and regulatory requirements while maintaining audit readiness.

You will review and approve SOPs and batch records, handle deviations and CAPA, coordinate with QA/QC teams, and drive training on GMP practices to ensure timely, compliant documentation across production.

Qualifications

• B.Pharm / M.Pharm
• Minimum 12+ years of experience in production documentation
• Experience in semi-solid dosage forms
• Strong knowledge of cGMP, QMS, and regulatory compliance
• Good leadership and coordination skills

Responsibilities

• Ensure strict adherence to cGMP guidelines across manufacturing operations.
• Review and approve SOPs, formats, batch records, and documentation
• Handle deviations, CAPA, change controls, and risk assessments
• Coordinate with QA, QC, Stores, Tech Transfer, and QMS teams
• Monitor and track CAPA closure and ensure compliance
• Approve validation protocols, cleaning validation, and qualification reports
• Ensure timely completion of batch documentation
• Conduct training on SOPs, deviations, and GMP practices
• Maintain audit readiness and strong documentation practices
• Optimize manpower and equipment utilization.

Skills

cGMP

QMS

Leadership

Coordination

Education

B.Pharm

M.Pharm

Job description

Role Objective:

We are looking for an experienced professional to lead and manage manufacturing documentation and compliance activities, ensuring adherence to cGMP standards and regulatory requirements while maintaining audit readiness.

Key Responsibilities:

• Ensure strict adherence to cGMP guidelines across manufacturing operations.
• Review and approve SOPs, formats, batch records, and documentation
• Handle deviations, CAPA, change controls, and risk assessments
• Coordinate with QA, QC, Stores, Tech Transfer, and QMS teams
• Monitor and track CAPA closure and ensure compliance
• Approve validation protocols, cleaning validation, and qualification reports
• Ensure timely completion of batch documentation
• Conduct training on SOPs, deviations, and GMP practices
• Maintain audit readiness and strong documentation practices
• Optimize manpower and equipment utilization.

Qualifications & Experience:

• B.Pharm / M.Pharm
• Minimum 12+ years of experience in production documentation
• Experience in semi-solid dosage forms
• Strong knowledge of cGMP, QMS, and regulatory compliance
• Good leadership and coordination skills