ECSV Compliance Advisor

About the Role

​The eCSV Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.

Key Responsibilities:

Your contributions include, but are not limited to:

Implementation Projects

• Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system

• Work closely with the project manager to ensure all compliance milestones are met during the project lifecycle.

• Oversee and/or assists in the development of validation deliverables including Validation Plans, TestPlans/Protocols/Scripts,Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.

• Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.

• Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of products in alignment with applicable company policies and regulations.

• Coach the implementation teams in the proper execution of validation documents

• Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting.

• Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls. Ensureinitiation/preparationand closeout of all eCSV related deviations.

• Supply accurate KPIs to management on project compliance status

System Maintenance

• Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.

• Ensure all changes are implemented and documented in a compliant manner.

• Perform periodic assessment to review and confirm validated status.

• Perform periodic re-validations.

Quality Management

• Ensureinitiation/preparationand closeout of all eCSV related deviations, discrepancies and change control documents.

• Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.

• Follow up resolution of identified quality exposures and escalation to team lead if critical situations are not resolved in due course.

• Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability, and ensure the organization employs appropriate risk based approaches to delivery taking into account the output of the supplier assessment.

• Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the delivery teams and wider business.

Skills & Experience:

• A good engineering background with a focus on equipment/process validation.

• Understand of equipment which are controlled by PLC as part of a production line.

• Strong understanding of GXP Regulatations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.)

• Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.

• Detailed understanding of equipment/process validation.

• Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (QMS), Laboratory Infirmation Systems (LIMS) Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.

• Ability to rapidly adapt to new situations and environments.

• Excellent communication skills with the ability to effectively convey compliance requirements at all levels.

• Ability to influence, negotiate, and constructively challenge to achieve productive solutions.

• Ability to handle a high concentration of work through successful multitasking & prioritizing.

• Conscientious and highly committed, with a dedication to quality.

Qualifications/Education:

• Bachelor’s degree in computer science, engineering life science or related field

• Min. 2 years experience with equipment/process validation lifecycle management, validation documentation development.

• Min. 2 years experience in pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions.

• Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc.

• Excellent presentation and writing skills.

Travel Requirements:

• Position may involve travel up to 30 times per year, mainly to our site in Denmark.

Working Conditions

• Remote working model

• Occasional on‑site presence may be required for hands‑on validation activities on the machines, depending on business needs.

Note: Please send your CV only in English language.

Employee perks, benefits:

• Annual global incentive plan-bonus

• Large corporation with representation and manufacturing plants in the world

• Stable employer in Slovakia, Košice region

• Corporate culture – Underpinning everything we do are our values:

  • Improve Care
  • Deliver results
  • Grow together
  • Own it
  • Do what´s right

• Introduction program according to company standards

• Development trainings

• Career opportunities for internal employees

• Referral bonus system

• Recognition program

• Supplementary pension plan after the trial period with the employer's contribution

• Social fund (various support and perks for employees)