Computer Systems Validation (CSV) Manager

Pioneering trusted medical solutions to improve the lives we touch: Unomedical s.r.o. is a member of Convatec which 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 around 10,000 colleagues, we provide our products and services in almost 100 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 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com


Place of work: Slovakia (remote)
Wage (gross) and other rewards: minimum 2400€ / 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 Manager 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.

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, 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.

Skills & Experience:

• Bachelor’s degree in computer science, engineering life science or related field plus 5 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.
• 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.

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.

This is a challenge more worthwhile.

This is work that’ll move you.

#LI-ND1

#LI-Remote

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)

Company:

Unomedical s.r.o. (member of the global company Convatec)
Priemyselný park 3 
071 01 Michalovce, Slovakia

Email: job-slovakia@convatec.com
convatec.sk | convatecgroup.com | careers.convatec.com

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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 careers@convatec.com.

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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 careers@convatec.com.

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.