Deputy Manager, Manufacturing Process Operations

Amneal Pharmaceuticals; Dahej; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a senior QA/QMS professional to oversee GMP compliance, audit management, and lifecycle validation for peptide manufacturing. You will drive QMS activities, ensure data integrity, and coordinate with cross-functional teams to sustain inspection readiness.

Responsibilities include reviewing SOPs, supporting regulatory audits, and leading CAPA, deviation, change control, and OOS investigations while mentoring teams in a fast-paced manufacturing environment

Qualifications

• 8-12 years in QA/QMS of API or Peptide manufacturing.
• Experience with GMP, data integrity, regulatory guidelines.
• Experience leading audits and QA/QMS processes.

Responsibilities

• Lead QA/QMS oversight for FAT, SAT, Commissioning and Validation activities.
• Review and approve IQ, OQ and PQ protocols and reports for equipment, utilities, facilities and computerized systems.
• Support Process Validation, Cleaning Validation and Technology Transfer activities.
• Ensure compliance with cGMP, Data Integrity, USFDA, EU GMP and ICH guidelines.
• Drive inspection readiness, quality culture and continuous improvement initiatives.
• Coordinate with Manufacturing, QC, Engineering, Warehouse and Regulatory teams.

Skills

GMP Compliance

QMS Management

Audit Handling

IQ/OQ/PQ

Validation

Investigation Management

Leadership

Regulatory Compliance

Education

M.Pharm / B.Pharm / M.Sc. Chemical Engineering (Chemistry/Biotechnology)

Job description

• Peptide Upstream Downstream Manufacturing: Lead SPPS operations covering resin charging/swelling, Fmoc deprotection, amino acid coupling, washing, cleavage and filtration. Ensure execution as per approved BMR/BPR, SOPs, process parameters, quality requirements and production schedules; monitor yields, solvent/material consumption and equipment utilization. Manage QMS activities including Deviation, CAPA, Change Control, OOS, OOT, Risk Assessment, and Audit Compliance.
• Review and approve SOPs, protocols, reports, and quality documents.
• Lead customer, regulatory, and internal audits ensuring GMP compliance.
• Provide QA oversight for FAT, SAT, Commissioning, and Validation activities.
• Review and approve IQ, OQ, and PQ protocols and reports for equipment, utilities, facilities, and computerized systems.
• Support Process Validation, Cleaning Validation, and Technology Transfer activities.
• Ensure compliance with cGMP, Data Integrity, USFDA, EU GMP, and ICH guidelines.
• Drive inspection readiness, quality culture, and continuous improvement initiatives.
• Coordinate with Manufacturing, QC, Engineering, Warehouse, and Regulatory teams.
• Key Skills: GMP Compliance, QMS Management, Audit Handling, IQ/OQ/PQ, Validation, Investigation Management, Leadership, and Regulatory Compliance.

Job Description

• Peptide Upstream Downstream Manufacturing: Lead SPPS operations covering resin charging/swelling, Fmoc deprotection, amino acid coupling, washing, cleavage and filtration. Ensure execution as per approved BMR/BPR, SOPs, process parameters, quality requirements and production schedules; monitor yields, solvent/material consumption and equipment utilization. Manage QMS activities including Deviation, CAPA, Change Control, OOS, OOT, Risk Assessment, and Audit Compliance.
• Review and approve SOPs, protocols, reports, and quality documents.
• Lead customer, regulatory, and internal audits ensuring GMP compliance.
• Provide QA oversight for FAT, SAT, Commissioning, and Validation activities.
• Review and approve IQ, OQ, and PQ protocols and reports for equipment, utilities, facilities, and computerized systems.
• Support Process Validation, Cleaning Validation, and Technology Transfer activities.
• Ensure compliance with cGMP, Data Integrity, USFDA, EU GMP, and ICH guidelines.
• Drive inspection readiness, quality culture, and continuous improvement initiatives.
• Coordinate with Manufacturing, QC, Engineering, Warehouse, and Regulatory teams.
• Key Skills: GMP Compliance, QMS Management, Audit Handling, IQ/OQ/PQ, Validation, Investigation Management, Leadership, and Regulatory Compliance.

Qualifications

Qualification: M.Pharm / B.Pharm / M.Sc. Chemical Engineering (Chemistry/Biotechnology)

Experience: 8-12 years in QA/QMS of API or Peptide manufacturing.