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Compliance and Validation Consultant

Permanent contract
Prague
Salary: Not specified
No remote work

NNIT Czech
NNIT Czech

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The position

Job description

Would you like to be part of the leading European IT company dedicated to providing consulting services to Pharma & Life Sciences customers? Does your passion lie within ensuring the Quality, Compliance and Validation, as well as setting direction and advising and training colleagues? Then here is a great opportunity to join our Global Compliance & Validation Services Team in NNIT Czech Republic.

About your new team

You will be part of the Global Compliance & Validation team that is currently expanding in the Czech Republic. Our overall objectives are planning and executing end to end Qualifications and Validation both for GxP and non-GxP systems, ensuring Computerised systems and IT Infrastructure projects are in compliance with the existing regulatory requirements within the Life Science industry.

Your responsibilities include, but are not limited to:

• Lead project compliance work streams and responsible for end to end quality and compliance aspect of the project and validation deliverables and perform validation impact analysis and risk assessments, both high level and functional, to ensure requirements coverage.

• Manages compliance of the system during its lifecycle, with regards to Regulatory, NNIT and customer Internal Standards. This is performed through document reviews & coordination of various activities including testing, performing Project reviews etc.

• Author key validation deliverables provide GxP related validation expertise and Partner with key business stakeholders (i.e. Manufacturing, Quality, Validation, Risk and Compliance, etc.) in defining the CSV strategy. Should be thorough with Document Management processes i.e. create, review, update and approve CSV deliverables including Validation Assessment, Validation Plan, Test Plan, Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Traceability Matrix and Validation Summary Report.

• Provides compliance & risk management guidance for IT projects. Ensure implementation and monitoring of IT compliance, records management and information risk management during IT projects, to ensure the integrity, confidentiality and availability of information owned, controlled or processed by the organization.

• Evaluates the risks arising from control deficiencies, gaps and facilitates risk mitigation planning. First point of contact for all quality related queries on the projects, follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course.

• Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests. Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable. Manage appropriateness of preparation and readiness of the project for handover of the system/processes to the operational organization together with the project managers.

 

What you’ll bring to the role:

- Experience with working with validated computer systems, GxP and Quality Management

-Experience working within the guidelines provided by regulatory agencies such as FDA, MHRA, etc. on one or more of the following areas: CFR Title 21 (parts 11, 210, and 211), Annex 11, GAMP, V-Model, CAPA, GxP (GMP, GLP, GCP, GVP, etc.), ERES regulations and Computer Systems Validation (CSV) coupled with ability to apply the same.

- Knowledge about GAMP framework

- Knowledge about major regulations impacting computerised systems, MES, and other types of applications used in the pharmaceutical domain.

- Experience with creating and reviewing the validation documentation for regulated pharma industry.

- Excellent communication skills and fluent English, both spoken and written

 

Employee benefits

- 5 weeks of vacations/year

- 5 sick days/year

  • Flexible working hours
  • Cafeteria flexible spending account (12,000 CZK/year)
  • Meal vouchers in the amount of 100 CZK per workday (NNIT covers 55 CZK)
  • Fully covered MultiSport card enabling free entry to sports facilities in the Czech Republic
  • Mondays breakfasts and monthly Friday Bars (free beer and snacks)
  • Free fruits and vegetables in the office

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