eCSV Compliance Advisor

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: 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). To learn more please visit

Place of work: Slovakia (Remote)

Wage (gross) 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 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. 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

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 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. 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, 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

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 (if applicable):

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 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 computer system validation and infrastructure qualification, including the application of risk managed approaches

Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), 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/other degree in computer science, engineering life science or related field, plus 2 years experience with CSV validation lifecycle management, validation documentation development.

- 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 (local and Convatec corporate e.g. Code of Ethics and Business Conduct, Quality Policy, Complaints, relevant GxP documents), including regular re-training when required

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.

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)

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Beware of scams online or from individuals claiming to represent ConvaTec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official ConvaTec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at ConvaTec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .

Dajte si pozor na podvody online alebo od jednotlivcov, ktorí tvrdia, že zastupujú spoločnosť ConvaTec

Pred akoukoľvek ponukou práce, sa vyžaduje formálny náborový process, pre všetky naše pracovné príležitosti.

To bude zahŕňať, pracovný pohovor potvrdený oficiálnou e-mailovou adresou spoločnosti ConvaTec.

Ak Vás osloví podozrivý kontakt cez sociálne médiá, textovú správu, e-mail, alebo telefonát, o nábore v spoločnosti ConvaTec, nezverejňujte žiadne osobné údaje, ani neplaťte žiadne poplatky.

Ak si nie ste istí, kontaktujte nás na adrese .

Equal opportunities

ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Rovnaké príležitosti

ConvaTec poskytuje rovnaké pracovné príležitosti, pre všetkých súčasných zamestnancov a uchádzačov o zamestnanie. Táto politika znamená, že nikto nebude diskriminovaný z dôvodu rasy, náboženstva, vierovyznania, farby pleti, národnostného pôvodu, národnosti, občianstva, pôvodu, pohlavia, veku, rodinného stavu, fyzického alebo mentálneho postihnutia, citovej, alebo sexuálnej orientácie, rodovej identity, vojenského statusu, alebo statusu veterána, genetických predisponujúcich vlastnosti, alebo z akéhokoľvek iného dôvodu, zakázaným zákonom.

Notice to Agency and Search Firm Representatives

ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Upozornenie pre zástupcov agentúr a vyhľadávacích spoločností

Spoločnosť ConvaTec neprijíma nevyžiadané životopisy od agentúr a/alebo vyhľadávacích spoločností pre túto pracovnú ponuku. Životopisy predložené akémukoľvek zamestnancovi spoločnosti ConvaTec, treťou stranou, ako sú agentúry a/alebo vyhľadávacie spoločnosti, bez platnej písomnej a podpísanej zmluvy o vyhľadávaní, sa stanú výhradným vlastníctvom spoločnosti ConvaTec.

Already a ConvaTec employee?

If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View "ConvaTec Internal Career Site - Find Jobs". Thank you!

Ste už zamestnancom spoločnosti ConvaTec?

Ak ste aktívnym zamestnancom spoločnosti ConvaTec, prosím, neaplikujte tadiaľto. Prejdite na stránku pracovných príležitosti, na svojej domovskej stránke Workday a zobrazte si Interná kariérna stránka spoločnosti ConvaTec – Nájsť pracovné miesta“. Ďakujeme!

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.

Information about personal data processing of job seekers is located on link:

Na osobný pohovor budú pozvaní uchádzači, ktorí spĺňajú naše požiadavky. Materiály neoslovených uchádzačov budú v súlade s nariadením GDPR a so zákonom o ochrane osobných údajov skartované.

Informácia o spracúvaní osobných údajov uchádzačov o zamestnanie sa nachádza na:

JR00018961

Remote/Remotely/Tele/Telecommute/From home