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Junior Computer System Validation (CSV) Specialist
2-5 years
Pune
1 vacancy
Junior Computer System Validation (CSV) Specialist
MSD Pharmaceuticals
posted 1d ago
Job Role Insights
Flexible timing
Key skills for the job
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)
- Bachelors 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, L ta ka, 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
Employment Type: Full Time, Permanent
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What people at MSD Pharmaceuticals are saying
Specialist salary at MSD Pharmaceuticals
reported by
3
employees
with 4-15
years exp.
₹18
L/yr - ₹33
L/yr
151%
more
than the average Specialist Salary in India
View more details
What MSD Pharmaceuticals employees are saying about work life
based on 255 employees
Flexible timing
Alternate Saturday off
Within city
Day Shift
MSD Pharmaceuticals Benefits
Health Insurance 
Job Training 
Soft Skill Training 
Education Assistance 
Work From Home 
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