Deputy Manager Manufacturing Process Operations

Amneal Pharmaceuticals LLC; India; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks an experienced QA/QMS professional to lead upsteam/downstream peptide manufacturing QA and QMS activities. You will manage deviations, CAPA, change controls, OOS/OOT investigations, and audit compliance while reviewing SOPs, protocols, and quality documents.

The role requires overseeing FAT/SAT, validation activities, and regulatory audits to maintain GMP standards.

Qualifications

• 8–12 years in QA/QMS for API or peptide manufacturing.
• Experience with GMP, QMS, deviations, CAPA, and audits.
• Ability to lead audits and ensure regulatory compliance.

Responsibilities

• Provide QA oversight for 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.

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

Job description

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.

Requirements: