ConvaTec Jobs

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 2900€ / 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

Job Summary

As a Computer System Validation (CSV) Lead you will be responsible for all aspects of computer systems validation/qualification. This includes the planning and coordination for any Inspection/Audits readiness and support. This role provides compliance consulting on various technology throughout the build, install and maintenance phases.. The Lead will have oversight all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, CSV procedures, and Data Integrity. You will lead IT in different projects/ initiatives for CSV that will address areas of improvement and simplification of actual processes as the evaluation, development, and implementation of the Computer Software Assurance (CSA). This role is also responsible for providing the necessary oversight of system related issues, employ risk-based methodology, lead teams on those assessments and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. This Manager will facilitate the Demand Management process for all requirements in projects, enhancements, and changes and will review and approve CSV strategies/plans, devise compliance maturity assessments and remediation plans.

Responsibilities include but are not limited to:

Business Relationship

• Collaborate with Quality Assurance Quality Systems, and Clinical QA Organizations to ensure that IT CSV and GxP processes and related procedures are in alignment with Quality/ Regulatory Policies and SOPs.

• Collaborate with global and local business stakeholders to ensure strategies are communicated, understood and adhered to

• Provide regular communication to Senior Director about key indicators and milestones related to IT CSV Maturity Capability and Deviations.

IT CSV and Inspections/Audits Support Organization

• Lead/Manage the IT CSV Engineers, and IT CSV Projects Contractors.

• Keep updated organizational diagrams, job descriptions, training requirements lists, and RACIs.

IT Computer Systems Validation and Improvement/ Matureness Projects

• Lead and conduct system compliance risk assessments to determine the decisions for validations and scope.

• Ensure proper development and management of GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOP's, Change Control Documentation, and Risk Assessment reports.

• Ensure all policies, processes and applications/ systems that managed by IT are in GxP compliance through embedded compliance in phases for design, development, testing, documentation, implementation, training and maintenance.

• Actively collaborate with project stakeholders and the IT team to define needs and achievable solutions and/or justifications to system requirements.

• Work with overall project manager to include validation activities in implementation timelines.

• 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.

• Lead the analysis of Data Integrity impact in IT in projects, initiatives, and changes evaluations to ensure compliance in systems, applications, and processes implementations.

• Identify CSV areas that IT needs to improve and lead organization in those projects and initiatives that will address improvement and simplification.

• Provide the necessary oversight of system related issues, employ risk-based methodology, lead teams on those assessments and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Develop a Compliance Plan for Periodic Reviews.

IT Compliance Assessments (Systems/ Process)

• Determine the compliance requirements for IT Compliance Assessments and establish a plan for maturity in terms of GxP, CSV and Data Integrity.

• Define continuous improvements initiatives for the IT Compliance Assessments for systems and processes, and all related policies, procedures, templates, and plans. That program and improvements should be reviewed with IT Management, QA/QS, and IT Security.

• Responsible for defining and documenting effective Action Plans together with agreements with process/ systems owners. Follow up will be performed to ensure that CAPAs are completed and well documented.

Readiness and Support - Internal/Mock Audits and Regulatory Inspections

• Plan includes gap assessments/ analysis to properly identify opportunities and areas of improvement.

• Develop and offer awareness and training about programs for IT Compliance Assessments, Inspections Readiness and Support. Also, it is important to cover key information about Regulatory Inspections and differences in terms of GMP, GLP, and GCP.

• Properly coordinate internal assessments including scope, schedule, and assessors.

Access Management

• Actively contribute to the development of the Access Management Program, related procedures, and templates. Documentation should include details about audit trails, and monitoring activities.

• Contribute to a detailed RACI establishing the main responsibilities and roles to ensure that the IT Access Management process complies and is effectively managed/ monitored.

Data Integrity

• Active participation supporting the IT Data Integrity plan in alignment with QA strategy and plans including the Site Data Integrity Master Plan.

• Evaluate that Convatec IT has policies and procedures for Data Integrity and lead for the uniformity and alignment of that process for IT in all Convatec Sites.

• Support all actions and remediation plans related to the Data Integrity Plan in IT to ensure all elements, actions, target dates, and resources are properly defined and then communicated.

• Ensure that projects, initiatives, and changes are evaluated in terms of Data Integrity impact to achieve compliance in systems, applications, and processes implementations.

• Ensure that Data Integrity principles and processes are part of the Audits/ Inspections Program for Convateci888 Sites to ensure compliance with current regulations.

Risk Management (RM)

• Support continuous improvement and matureness of the Risk Management process to assess the overall IT Risk, its implications to Business Operations and the definition of mitigation plans to ensure risks are minimized and/or significantly reduced.

• Provide input/ feedback to the Risk Criteria about compliance aspects related to GXP and CSV.

• Actively participate in risk assessments to ensure IT CSV area/ processes are considered, root cause is properly defined, and effective mitigation actions are established.

General - IT Compliance and Documentation

• Keep updated knowledge and training in all guidelines from Regulatory Agencies to ensure proactive alignment of IT Computer Systems, Applications, and all processes to required compliance.

• Lead and contribute documenting RACIs for the IT CSV, IT Change Management and key IT processes. RACIs will establish the main responsibilities per roles in IT, QA, and related departments, in conjunction with Service Management.

• Support IT Colleagues in documentation of incidents/ issues and QA Deviations in compliance with GxP and following the QA/QS SOP related to deviations and CAPAs.

About you:

• Bachelor’s degree in Computer Science, Engineering or technical field OR the equivalent combination of bachelor’s degree and CSV and GxP years of experience as required.

• 12-15 years of experience in a Computer Systems Validation leadership position/ role developing and implementing related processes and documentation. Also, experience in Data Integrity, Periodic Reviews, Risk Management, Change Management, and Access Monitoring/ Management.

• Experience with GAMP 5 and Computer Systems Validation within FDA (GxP) regulated environments.

• Knowledge/experience in CSA (Computer Software Assurance) and related processes/ documentation.

• Knowledge and experience in GxP Guidelines; 21 CFR - Parts: 11, 210, 211, 820-QSR; Annex 11- ERES.

• Experience validating and qualifying applications for different business areas as HR, Supply Chain, Manufacturing, Labs, Regulatory, Quality Assurance and Quality Systems, among others.

• Experience developing validation documentation and testing protocols (IQ/OQ/PQ/UAT) within various SDLC phases, and processing documentation using an Electronic Testing System.

• Experience in VERA + ALM is a plus.

• Experience in Trackwise and Documentum is a plus.

• Background/experience in inspection readiness, inspections support and establishing action plans based on observations/findings after inspections.

• Experience with regulatory agencies (e.g., FDA, MHRA, EMA, ANVISA) presenting/explaining CSV documentation and processes, sharing details about IT GxP processes and establishing actions plans for any possible observation or recommendation.

• Experience using Microsoft Office software, as well as application of technical writing best practices and principles. Experience writing, reviewing, and approving procedures and compliance documentation.

• Experience validating document management, quality management, regulatory publishing/information management, and/or learning management systems is highly advantageous.

Abilities/Skills :

• Collaboratively work with IT and QA/QS Organizations to ensure alignment in validation plans and processes with focus in compliance achievement.

• Functional technology knowledge, and business processes perspective to facilitate compliance and IT Security requirements are embedded in IT CSV.

• Domain of Validation, SDLC (System Development Life Cycle) methodologies, system documentation including but not limited to user requirements, validation protocols, summary reports and SOPs.

• Good interpersonal skills with ability to analyze situations, present alternatives and lead to establish/ define solutions and related action plans.

• Must be able to effectively work in a fast-paced environment, be flexible, and possess the ability to adapt to shifting priorities, to work independently as well as part of a team.

• Demonstrated ability to participate in problem-solving discussions and lead the definition of actions plans.

• Good in hands-on and end-to-end CSV projects experience and application of project controls - including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management.

• Understanding of data integrity and access management compliance guidelines and risks.

• Ability to manage complex projects and timelines in a matrix team environment. Able to independently identify compliance risks and escalate when necessary. Able to lead meetings to evaluate CSV implications in projects and proposed changes.

• Ability to work with multiple clients and projects, and able to manage priorities.

• Experience and proficient with Word, Excel, PowerPoint, and MS Teams.

• Good oral and written communications skills. Able to communicate and make presentations to all levels of management and technical/ nontechnical personnel.

• Leader with strong negotiation and influencing skills ensuring gaps analysis, problems solutions, risk-based decisions, and value maximization. Good in process and organization skills.

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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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.

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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.

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Informácia o spracúvaní osobných údajov uchádzačov o zamestnanie sa nachádza na: http://www.convatec.sk/o-nás/kariéra/ (http://www.convatec.sk/o-n%C3%A1s/kari%C3%A9ra/)