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الوصف الوظيفي

Job Description


Preferably to our tech center in Prague, alternatively to Pune, we are seeking a Junior Computer System Validation (CSV) Specialist to ensure the adherence of our IT organization to established policies/procedures and regulatory requirements. As a key member of our compliance team, you will engage with IT practitioners and act as a consultant for the System Development Life Cycle (SDLC), Compliance Risk Profile, Digital SDLC, Good Documentation Practices, and IT Control Requirements Set including the adoption of agile ways of working. Furthermore, you will support audit/inspection readiness, participate in the timely review and Corrective and Preventative Action (CAPA) response, and monitor IT compliance indicators.


Responsibilities


  • Engage with IT practitioners and act as a consultant for the System Development Life Cycle (SDLC), Compliance Risk Profile, Digital SDLC, Good Documentation Practices, and IT Control Requirements Set including the adoption of agile ways of working


  • Ensure that the IT organization operates and complies with established policies/procedures


  • Support audit/inspection readiness and participate in the timely review and Corrective and Preventative Action (CAPA) response


  • Monitor IT compliance indicators, evaluate impacts, and ensure non-compliance incidents are communicated and actioned


  • Oversee policies, SOPs, supporting documents, and associated materials to ensure seamless integration with other processes


Qualifications (Education minimum requirements subject to change based on country)


  • Bachelor's degree in Computer Science, Information Technology, or related field


  • Professional certifications such as Certified Information Systems Auditor (CISA) or Certified in Risk and Information Systems Control (CRISC) are preferred


  • Excellent communication and interpersonal skills


  • Technical Advice: Possess the ability to provide technical advice and guidance related to compliance and quality management


  • Quality Management: Demonstrate strong knowledge and practical application of quality management principles and processes


  • Quality Assurance (QA): Ability to ensure that the IT organization is adhering to quality standards and requirements


  • Audit Management: Experience in managing audit processes, preparing for audits, and responding to audit findings


  • Risk Management: Ability to identify, assess, and mitigate risks related to IT compliance


  • Governance Management: Strong understanding of governance frameworks and the ability to manage compliance within these frameworks


What we offer (The primary location is Czechia, benefits in other country may vary)


  • Exciting work in a great team, global projects, international environment


  • Opportunity to learn and grow professionally within the company globally


  • Hybrid working model, flexible role pattern


  • Pension and health insurance contributions


  • Internal reward system plus referral programme


  • 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution


  • Cafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport Card


  • Vodafone, Raiffeisen Bank, Foodora, and Mall.cz discount programmes


  • Up-to-date laptop and iPhone


  • Parking in the garage, showers, refreshments, massage chairs, library, music corner


  • Competitive salary, incentive pay, and many more



Ready to take up the challenge? Apply now!
Know anybody who might be interested? Refer this job!


#AHIT2024


Current Employees apply HERE


Current Contingent Workers apply HERE


Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 


Employee Status:


Regular

Relocation:


VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:


Hybrid

Shift:


Valid Driving License:


Hazardous Material(s):


Job Posting End Date:


11/28/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


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