Business Risk and Compliance Expert
hace 2 días
About the Role:
The Technical Business Analysis, Analyst II is responsible for engaging with diverse stakeholders to capture business and technology requirements for defined solutions at Takeda Pharmaceutical. This role contributes to the company's mission by improving business processes through new technology or alternative uses of existing technology.
Key Responsibilities:
- Validate computerized systems, focusing on laboratory and R&D systems: drafting validation plans, reviewing specification documentation.
- Specify user requirements.
- Conduct risk analysis.
- Draft and review DQ, IQ, OQ, and PQ testing protocols.
- Execute validation tests and create phase reports.
- Provide support during system implementation.
- Develop and review Standard Operating Procedures (SOPs).
- Ensure IT/QA Compliance: evaluate the compliance of computerized systems with respect to data integrity requirements and propose remedial actions based on the level of risk associated with identified gaps.
- Support and execute data integrity compliance remediation actions on laboratory and production systems.
- Review generated validation documentation.
- Prepare and update policies, SOPs, standards, and validation templates regarding corporate policies and standards.
- Review validation documentation for compliance with SOPs and approved validation standards.
Qualifications:
- +3 years of experience in a similar role
- Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science).
- Preferred experience in computer system validation.
- Preferred knowledge of regulatory requirements and guidelines applicable to the pharmaceutical and biotechnology industry.
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration skills.
- Attention to detail and a commitment to data integrity and quality.
Locations: Takeda Pharmaceutical
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
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