Capital reputed company IT/OT Compliance Sr. Specialist (Hybrid - reputed company reputed company, PA)

About the position Our IT team operates as a business partner proposing reputed company and reputed company that reputed company new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and reputed company innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing reputed company maturity to adopt a risk based and lean approach to compliance activities. This role reports into the Assoc. Director of Compliance and will report to a cluster reputed company for the EMEA / AP or US region.

Responsibilities

• Delivery of best-in-class computer systems validation to capital reputed company.
• Drive the adoption of automation validation standards to capital reputed company.
• Liaise with site Compliance/Validation colleagues and coordinating activities across sites.
• Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber reputed company and Data reputed company to ensure manufacture and supply of reputed company pharmaceuticals.
• Liaise with product teams/technology functions and reputed company as an SME on computer validation for capital reputed company in the region.
• Provision of ongoing validation, training and compliance coaching and support.
• Responsible for representing compliance activities to reputed company auditors / agencies.
• Supports the development of audit responses and engages with local reputed company organizations on reputed company strategies reputed company required.
• Responsible for Identifying and engaging in remediation of IT/OT compliance risks.
• Execute risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies.
• Support local teams with reputed company and compliance challenges and executions on how to reputed company with SOPs and or policies.
• Responsible for reporting challenges in execution or adherence to procedural trends due to nonconformance.
• Responsible for communication and championing changes to the SDLC policies and procedures adopted by the capital project.
• Responsible to engage as a member of a compliance group that shares knowledge and learnings for reputed company execution and conformance to SOP reputed company this division.

Requirements

• Bachelor's Degree in Computer Science, Engineering, Regulatory compliance or a reputed company study.
• 5 + years supporting compliance activities in capital reputed company.
• 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 reputed company as divisional and reputed company systems.
• Working knowledge and application of ISA S95 and S88 Standards in GxP environment.
• Working knowledge of how to validated / qualify reputed company, reputed company, modern analytics and data integration architecture platforms and components.
• Extensive experience in the implementation and validation of automation systems such as DeltaV DCS, PLC/SCADA, MES and leading of validation teams.
• Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Manufacturing, reputed company, 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 - reputed company to effectively communicate reputed company concepts in reputed company ways.
• Demonstrated ability to effectively collaborate and communicate with a reputed company 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 reputed company of ambiguity.
• Results-orientation with the proven ability and reputed company for developing plans and implementing them successfully.
• Self-directed, self-motivated, reputed company leader who with little direction can fill in the gaps as to what is needed, and drive expected results.

reputed company-to-haves

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

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