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Senior Risk & Compliance Validation Specialist

Job Advert

Senior Risk & Compliance Validation Specialist

Warsaw IT Hub

 

The role of the Risk and Compliance Validation team is to provide governance over CSV processes, provide insight into validation activities and expand CSV awareness across Reckitt organization resulting in Reckitt achieving the appropriate compliance.

 

You'll...

  • Create and maintain Computerized Systems Validation related procedures, guidelines and templates;
  • Review and approve validation deliverables;
  • Provide oversight and assurance to IT projects/remediation/BAU activities assuring compliance in-line with but not limited to external regulations and Reckitt Policies, Procedure and Standards;
  • Ensure that Reckitt global and local standards regarding IT controls and Computer Systems Validation are implemented and adhered to;
  • Work with business users /IT staff/ integrated IT partners to identify and scope validation/infrastructure qualification related activities;
  • Identify compliance risks/ remediation actions (with respect to Pharmaceutical industry regulations impacting computer systems) and proactively work with the business and IT to address these;
  • Provide leadership to ensure that computer systems validation activities are implemented consistently across applicable RB programmes;
  • Coaching, Guidance and Assurance to project teams on computer systems validation deliverables;
  • Influence and enforce Good Documentation Practice standards;
  • Auditi Reckitt GxP computerized systems to ensure adherence to external and internal regulations.
     

You’ll succeed, if you have...

  • Degree qualification in science or IT subject, or life science background or related discipline;
  • Qualification in project management techniques (nice to have);
  • Good understanding of healthcare/pharmaceutical/medical device IT validation expectations;
  • At least 5 years of experience in Pharmaceutical business processes including FDA/MHRA approved and validated systems environments;
  • At least 5 years of experience dealing with 21 CFR Part 210, 211, 820 and 21 CFR Part 11, Annex 11 and DEA regulations;
  • At least 5 years of experience in CSV methodology and GAMP standards;
  • Good working knowledge of Microsoft products such as Word, Excel, PowerPoint;
  • Excellent Computer Systems Validation skills;
  • Experience in designing and managing Validation activities for Global Level Programmes;
  • Attention to detail when reviewing documentation;
  • Proficiency in English;
  • Good organisational skills;
  • Up-to-date knowledge of GxP Regulations, industry trends, inspection findings etc;
  • Ability to work to tight timelines, under high pressure.
     

You’ll love it because you'll...

  • Cooperate with stakeholders from all over the world and build products for consumers in numerous countries, 
  • Join friendly and ambitious team within dynamic global company,
  • Work on diverse projects in the fast-growing technology sectors, 
  • Permanent contract with a wide package of additional benefits.

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Medical, Medical Device, Healthcare

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