Computer System Validation (CSV) Specialist (CSV, CQV, Compliance, GxP)

About the Role/Project

The resource will act as a Validation Consultan either for the client or for NNIT. Key responsibilities are ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV), lifecycle procedures, and data integrity requirements.

The Validation Consultant is responsible for preparing Validation Plans, Specifications, and Qualification documentation, so the total IT delivery meets customer needs and regulatory requirements. The Validation Consultant will provide input to project milestones and reporting.

Duties and Responsibilities:

• Proactively fulfill the role as a Validation Consultant in small to medium complex Life Sciences IT projects.
• Independently prepare validation documents.
• Assist the Project/Program Manager, the Project Validation Lead, Quality Project Lead or Project Validation Manager with quality and risk management issues Conduct risk management assessments/workshops, and provide input to validation and test strategies.
• Contribute to Quality Activities for Computer System Validation (CSV) projects/activities (including areas related to Data Integrity/ER).
• Participate in small to medium complex E-2-E Validations.
• Review IT projects and operations documentation to ensure process requirements are met according to the controlling QMS.
• Identify and implemen process improvements.
• Prepare testing activities – IQ, OQ, PQ including deviation handling and supported reporting.

Qualifications:

• At least 3 years of experience working in Consultant/Quality role
• Experience working with validated computer systems (CSV), GxP and Quality Management
• Good knowledge of most phases of the V-model/Agile delivery methodology, and ISPE GAMP5 guidelines
• Experience in creating and reviewing documentation.
• Life Sciences, biotech orpharmaceutical experience
• Strong verbal and written communication skills
• Ability to work independently and with teams at various levels in the organization
• Ability to work in a very dynamic environment with a clear sense of urgency
• Excellent organizational skills,with strongattention to detail and accuracy

Nice to have:

• Experience in quality management of IT applications or infrastructure, preferablyfrom working in the Life Sciences industry .
• ISPE/ECA GAMP5 training or certification
• ISTQB Foundation Certification
• Veeva certification.
• MS AzureDevOps AZ900 course
• SAFe Agile Foundation
• HP ALM or TLMS Testing
• MS AzureDevOps AZ900 training
• MES (Manufacturing Execution System) such as MODA-ES and other software related to MES)
• Knowledge of Validation Lifecycle Management Systems (VLMS), e.g. Kneat, ValGenesis.
• Experience with test automation tools, e.g. LeapWork, TOSCA, UIPath, other
• Experience in pharmaceutical production or IT Laboratory
• Experience with Track & Trace/Serialization
• Experience or knowledge of IT infrastructure

WHO WE ARE

NNIT is a fast-growing IT company with ambitious goals and 2,400 employees. At NNIT, you can make your mark on some of the most challenging projects in the industry, on our journey forward as a company, and on your own career. You'll work in agile teams with other passionate people in a culture with room for independent thinking and individual responsibility.

We supply IT services to large enterprises that demand high levels of quality and security, and we take on the responsibility for our clients IT as if it were our own. We live our values every day, so you should be able to see yourself in them. We are: Conscience driven. Value adding. Open and honest.

Our everyday work is characterized by an open and honest atmosphere, and we put emphasis on creating a challenging yet fun working environment. We pay significant attention to job satisfaction, and personal and professional development.

On top of the statutory benefits stipulated by the local law, NNIT DLSP employees enjoy the following benefits upon joining:

• Competitive Compensation
• 13th Month Pay
• Performance Bonus (discretionary)
• Rice Subsidy
• Communication Allowance
• Clothing and Laundry Allowance
• Medical Allowance (Employee and Dependent)
• HMO (Employee and Dependent/s)
• Life Insurance
• Vacation Leaves and Sick Leaves
• Emergency Loan
• Year-End Gift
• Wedding Gift
• First Baby Gift
• Breakfast once a week
• Fruits, Snacks / Well-stocked pantry
• Flexible Working Hours
• Hybrid set up

Related positions:

Commissioning, Qualification and Validation Engineer (CQV Engineer)

Computer System Validation Engineer / Computerized System Validation Engineer (CSV Engineer)

Process Engineer

Quality Assurance Engineer / QA Engineer

Validation Engineer / Validation Specialist

Software Validation Engineer

Software Testers / Software Engineer

System Engineer / System Validation Engineer

Notes:

1. By applying to this job ad, you acknowledge and agree for your information to be collected by NNIT. Rest assured, any information you share will only be used for recruitment/hiring purposes.

2. This position is available only to those with current authorization to live and work in the Philippines.