About the Role/Project
The resource will act as a Validation Consultant either for the client or for NNIT. Key responsibilities are ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV), lifecycle procedures, manufacturing execution systems (MES), and data integrity requirements specifically for SAP.
The Validation Consultant is responsible for preparing validation plans, specifications, and qualification documentation, so the total IT delivery meet customer needs and regulatory requirements. The Validation Consultant will provide to project milestones and reporting.
Duties and Responsibilities:
- Proactively fulfill the role as Consultant in small to medium complex Life Sciences IT projects.
- Independently author or review validation deliverables for SAP S/4HANA validation.
- 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 projects and operations documentation to ensure process requirements are met according to the controlling QMS.
- Prepare and execute testing activities – IQ, OQ, PQ including deviation handling and supported reporting.
Qualifications:
- At least 3 years of experience performing end-to-end CSV activities for SAP S/4HANA
- Has a Strong understanding of core SAP modules (MM, PP, QM, PM, EWM and SD)
- Has a Strong understanding of validation processes including creation of the deliverables and execution of protocols
- Experience in providing support to Manufacturing-IT and/or SDLC Management such as change, issue, incident, and release
- Good understanding 21 CFR Part 11, EU Annex 11 and regulatory requirements
- Good knowledge of most phases of the V-model/Agile delivery methodology, and ISPE GAMP5 guidelines
- Life Sciences, biotech or pharmaceutical experience
- Strong verbal and written communications skills
- Experience in presentation and has basic knowledge in data analytics
- Ability to work independently and with teams at various levels in the organization.
- Ability to work in a very dynamic environment with clear sense of urgency
- Excellent organizational skills with strong attention to detail and accuracy.
Nice to have:
- Experience in quality management of IT applications (ServiceNow, Trackwise) or infrastructure, preferably from working in the Life Sciences industry
- Knowledge in HP ALM, Valgenesis or Kneat
- ISPE/ECA GAMP5 training or certification
- ISTQB Foundation Certification
- Veeva certification
- SAFe Agile Foundation
WHO WE ARE
NNIT Philippines
NNIT Philippines builds on a decade of experience, and has a reputation for developing high quality enterprise level software solutions and support as a Microsoft Gold Certified Partner.
NNIT Philippines is an integrated part of NNIT's global IT service delivery, including specializations in the development and maintenance of enterprise and eGovernment software solutions as well as IT infrastructure operations including network and server operations for NNIT's customers around the world. The Manila based delivery center is part of NNIT's 24/7 Global Operations Centre setup and delivers services in close cooperation with NNIT's other centers in Denmark, China and the Czech Republic.
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
- 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
Note:
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.
