MSD Computer System Validation Specialist 

Czechia, Central Bohemia 

326460061

Job Description

The Specialist, Digital Foundational Services, IT/OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities. This role reports into the Associate Director of Compliance for above site systems.

What you should do

• ​Support various site functional and cross functional structures for all computerized system validation

• ​Support Divisional & Enterprise systems for all computerized system validation and IT/OT compliance issues

• Responsible for representing compliance activities to internal and external auditors / agencies

• Supports the development of audit responses and engages with local quality organizations on proper strategies when required

• Responsible for Identifying and engaging in remediation of above site IT/OT compliance risks

• Execute risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies

• Responsible for reporting challenges in execution or adherence to procedural trends due to nonconformance and accountable for the effective and efficient running of all compliance operations in the Automation and IT teams

• Responsible for reporting status for above site deviations / CAPAs and other quality records that will be used as indicators of control and conformance to policy

• Responsible for communication and championing changes to the SDLC policies and procedures for Digital Manufacturing Division

• Responsible to engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within Digital Manufacturing Division

• Liaise with Compliance teams from other sites to ensure consistency and best practices applied

How we see the ideal candidate

• 3+ years supporting compliance activities

• Bachelor’s Degree in Computer Science, Engineering, Regulatory Compliance or a related study preferred

• Proficient and demonstrated knowledge of regulatory requirements (21CFR part 11, EMEA Annex’s 11, etc) that apply to computerized systems validation and compliance for site based as well as divisional and enterprise systems

• Demonstrated ability to support internal and external auditors / agencies

• Working knowledge and application of ISA S95 and S88 Standards in GxP environment

• Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Manufacturing, Quality, and Supply chain

• Demonstrated ability to partner with stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs

• Outstanding written and verbal communication skills – able to effectively communicate complex concepts in simple ways

• Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide

• Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity

• Results-orientation with the proven ability and reputation for developing plans and implementing them successfully

• Self-directed, self-motivated, focused leader who with little direction can fill in the gaps as to what is needed, and drive expected results

• Technical, operational and business expertise in the following disciplines: Computer Systems Validation, Instrumentation / Automation & Control, Project Management

• Prior experience in the pharmaceutical industry, with specific experience in the Manufacturing, Supply Chain, and Manufacturing Quality areas – ideally involving cross industry collaboration to drive best practices

• Experience in integrating real time shopfloor and lab systems, at an enterprise level, with appropriate levels of resiliency and performance

• Experience in manufacturing analytics systems, including supply and demand forecasting, biologics process modelling and advanced image analysis

• Exposure to multiple, diverse technologies and processing environments

• Knowledge of business process re-engineering principles and processes

• Strong understanding of application development methodologies

What we offer

• 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 (e.g., even 80% full-time is possible in justified cases)

• 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

Current Contingent Workers apply

Preferred Experience and Skills:

• Prior experience in the pharmaceutical industry, with specific experience in the Manufacturing, Supply Chain, and Manufacturing Quality areas – ideally involving cross industry collaboration to drive best practices.
• Experience in integrating real time shopfloor and lab systems, at an enterprise level, with appropriate levels of resiliency and performance.
• Experience in manufacturing analytics systems, including supply and demand forecasting, biologics process modelling and advanced image analysis.
• Exposure to multiple, diverse technologies and processing environments.
• Knowledge of business process re-engineering principles and processes.
• Strong understanding of application development methodologies.

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

07/01/2024

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.