eCSV Compliance Advisor

About Convatec

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).

Place of work: Slovakia (Remote)

Wage and other rewards: Minimum 2000€ / monthly (depending on experiences and quality of the candidate) + annual global incentive plan‑bonus and other benefits in compliance with social benefit program of the company

Contract type: Full‑time

Start date: By agreement

Key Responsibilities

• The CSV Analyst will support GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems.
• Evaluate proposed new computerized systems or software to assess GxP impact and provide 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.
• Assist in the development of validation deliverables including Validation Plans, Test Plans/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.
• 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.
• Ensure initiation/preparation and closeout of all CSV 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

• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
• Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality.
• 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.
• Maintain up-to-date knowledge of evolving regulatory requirements and acts as an information resource for the delivery teams and wider business.

Other

• To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfillment of the company's targets in the EHS area.

Authority

• Project decisions that fall under Computerized Systems Validation internal or external guideline will be taken by the CSV Manager.
• Approve CSA documents that have a role CSV Manager / CSV Analyst / ITQA approval.

Skills & Experience

• Strong understanding of GxP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.).
• Demonstrated experience in successfully managing complex validation projects.
• Detailed understanding of computer system validation and infrastructure qualification.
• Experience in electronic software applications such as EDMS, PLM, eQMS, Complaint Management 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 & prioritising.
• Conscientious and highly committed, with a dedication to quality.

Qualifications / Education

• Bachelor’s / other degree in computer science, engineering life science or related field, plus 2 years experience with CSV validation lifecycle management.
• 2 plus years 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.

Preferred training requirements

• Quality System documents and procedures relevant to all employees.
• Quality System documents and procedures relevant to job performance.

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.
• 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).

Equality

Convatec provides equal employment opportunities for all current employees and applicants for employment.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting.

Internal Applicants

If you are an active employee at Convatec, please do not apply here.

Only candidates who meet our requirements will be invited for the interview.

Data of not selected candidates will be deleted in compliance with GDPR and data protection law.