ECSV Compliance Advisor

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.

Employee perks, benefits

• Annual global incentive plan-bonus
• Large corporation with representation and manufacturing plants in the world
• 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)

Requirements for the employee

• University education (Bachelor's degree)
• University education (Master's degree)
• English - Advanced (C1)