PHARMAFull-time
Manager, C&Q Document Preparation (Drug Substance)
HYDERABAD (IN)ONSITEPOSTED: 8/18/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Lead and manage a blended team of full-time employees and contingent resources responsible for the preparation, delivery, and review of Commissioning and Qualification (C&Q) documentation across Engineering capital projects and GMP manufacturing systems.
Oversee the end-to-end authoring and review of qualification protocols, summary reports, risk assessments, testing documentation, and Traceability Matrices (TM).
Execute documentation preparation in alignment with Center of Excellence (CoE) standardized templates, processes, and guidelines across Drug Substance, Drug Product, Finished Drug Product & Packaging, and Facilities & Utilities domains.
Partner cross-functionally with Engineering, Automation, Process Development, Validation, Quality, Manufacturing, and Facilities teams to ensure documentation readiness aligns with project timelines and operational goals.
Maintain continuous inspection-ready documentation and directly support regulatory audits and internal inspections.
Track project deliverables, identify technical and scheduling bottlenecks, and drive proactive risk mitigation strategies.
Lead continuous improvement initiatives to enhance documentation quality, operational efficiency, and regulatory compliance.
Technical & Quality Standards
Ensure all documentation strictly conforms to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), data integrity standards, and lifecycle validation approaches.
Drive risk-based qualification methodologies aligned with global biopharmaceutical regulatory guidelines.
Leadership & People Development
Provide operational leadership, coaching, and career development to team members while cultivating a culture of accountability, collaboration, and high-performance quality execution.
REQUIRED VERIFIED SKILLS
Commissioning and Qualification (C&Q)
GMP Documentation
Validation Protocols
Risk Assessments
Traceability Matrix (TM)
Team Leadership
Data Integrity
Inspection Readiness
Drug Substance Systems
COMPENSATION & REWARDS
₹22.0L - 38.0L per annum
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
RECOMMENDED TRAINING
1/5
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