What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.
This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.
Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for Minor and Major Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections.
Validation
- Demonstrated expertise in risk-based validation (RBV) methodologies, providing execution and guidance to cross-functional teams on complex GxP projects while ensuring alignment with Computer Software Assurance (CSA) principles.
- Proven ability to serve as the QA point of contact for assigned GxP systems, ensuring timely review and approval of documentation in compliance with Amgens standard operating procedures and applicable regulatory standards.
- Change Control Management: Drive Change Request (CR) and Change Control processes, from initiation through approval, ensuring accurate system impact assessment and documentation. (e.g Trackwise/Veeva , ServiceNow)
- Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards.
- Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices.
- System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production.
- Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards.
Periodic Review/Audit Trail
- System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance.
Supplier Management
- Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards.
Deviation & CAPA Management:
- Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution.
- Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards.
- CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution.
Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives.
Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards.
Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions.
Contributes to continuous improvement efforts and initiatives.
Assists with training initiatives and strategy as required.
Provides support for the Management Review Process when needed.
Supports the Integrated Systems Assessment (ISA) Process as necessary.
Participates in and aids with regulatory inspections as required.
The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy.
Basic Qualifications: - Masters / Bachelor's degree with a minimum of 10-14 years experience in Software and Systems Quality assurance
Preferred Qualifications: - Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards.
- Proven experience in the validation of computerized systems (GxP).
- Strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP).
- Experience managing quality assurance processes, including Major and Minor Deviations.
- Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills.
- Strong decision-making abilities with the capacity to drive tasks to completion.
- Ability to work independently with minimal supervision.
- Leadership skills with experience leading projects, teams, or tasks.
- Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo.
- Broad technical expertise within specialty area and familiarity with industry standards.
- Ability to provide training, guidance, and contribute to team quality.
- Works closely with senior staff and external experts to extend capabilities and enhance performance.
Data analysis skills (Good to have)- - Perform data analysis to create impactful visuals and dashboards for informed decision-making.
- Design clear, engaging charts and graphics for presentations and reports.
- Utilize tools like Power BI, Smartsheet , or similar to develop interactive, data-driven visuals.
- Translate complex data into concise, compelling visual stories for diverse audiences.
- Collaborate with cross-functional teams to align visual outputs with business goals.
