C&Q Document Preparation Support (Finished Drug Product)

Amgen Technology; Hyderabad; In loco; INR 1.200.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

Amgen is seeking a Senior Associate in Hyderabad to support commissioning and qualification lifecycle documentation across engineering projects and GMP manufacturing systems. You will author and revise CQ documents, coordinate review cycles, and ensure compliance with CQ standards and regulatory expectations.

You will partner with Engineering, Validation, Quality, Manufacturing, Facilities, Automation, and Project teams to deliver inspection-ready documentation and drive continuous improvement

Competenze

• Experience in GMP commissioning, qualification, validation, or technical operations.
• Experience authoring CQ lifecycle documentation including qualification protocols and reports.
• Knowledge of risk-based qualification methodologies and lifecycle validation approaches.
• Familiarity with GMP documentation practices and data integrity requirements.

Mansioni

• Prepare and revise commissioning and qualification lifecycle documentation for Engineering projects and systems.
• Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related CQ documents.
• Support document development using approved templates, standards, and CoE procedures.
• Coordinate technical review cycles and incorporate comments into final documents.
• Ensure documentation is accurate, complete, compliant, and inspection-ready.
• Collaborate with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to gather technical information.
• Track deliverables and support execution against project schedules and milestones.
• Maintain document organization and version control within quality systems.
• Support audit and inspection readiness activities as required.
• Contribute to continuous improvement initiatives focused on documentation quality and efficiency.

Conoscenze

CQ documentation

GMP knowledge

Technical writing

Cross-functional collaboration

Documentation compliance

Descrizione del lavoro

About the Role

Amgen is seeking a Senior Associate specializing in Commissioning Qualification (CQ) to join the Engineering CQ Center of Excellence (CoE). In this role, you will support the preparation, coordination, and delivery of commissioning and qualification lifecycle documentation supporting engineering projects and GMP manufacturing systems across Amgen operations.

The Senior Associate will partner closely with Engineering, Validation, Quality, Manufacturing, Facilities, Automation, and Project teams to develop compliant, inspection-ready documentation that supports commissioning, qualification, and operational readiness activities. This role plays an important part in ensuring documentation quality, consistency, and alignment with established CQ standards, procedures, and regulatory expectations.

This position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product Packaging, or Facilities Utilities.

Roles Responsibilities

Prepare and revise commissioning and qualification lifecycle documentation supporting Engineering projects and systems

Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related CQ documentation

Support document development activities using approved templates, standards, and CoE procedures

Coordinate technical review cycles and incorporate comments and revisions into final documents

Ensure documentation is accurate, complete, compliant, and inspection-ready

Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to gather technical information

Track assigned deliverables and support execution against project schedules and milestones

Maintain document organization and version control within applicable quality systems

Support audit and inspection readiness activities as required

Contribute to continuous improvement initiatives focused on documentation quality, consistency, and efficiency

Area-Specific Experience Preferred

• Experience supporting commissioning and qualification activities for packaging and finished drug product systems


• Familiarity with packaging equipment including labeling, cartoning, serialization, inspection, and automated packaging systems


• Experience preparing lifecycle documentation supporting packaging qualification and operational readiness activities


• Understanding of GMP requirements related to packaging operations, labeling controls, and serialization systems preferred


• Experience supporting commercial manufacturing startup or packaging line qualification activities preferred


• Familiarity with integrated packaging systems, vision systems, and automated material handling preferred

Preferred / Good to Have Qualifications Skills

Experience in GMP commissioning, qualification, validation, or technical operations

Experience authoring CQ lifecycle documentation including qualification protocols and reports

Familiarity with risk-based qualification methodologies and lifecycle validation approaches

Knowledge of GMP documentation practices and data integrity requirements

Experience working in a fast-paced capital project or startup environment preferred

Strong written and verbal communication skills

Strong organizational skills and attention to detail

Experience working in cross-functional project teams

Key Competencies

Technical Writing and Documentation Excellence

Attention to Detail and Quality Focus

Cross-Functional Collaboration

Planning and Execution

Problem Solving and Analytical Thinking

Continuous Improvement Mindset

Communication and Stakeholder Partnership