Senior Specialist Qualification Engineer
hace 2 días
Contribute to the improvement of business processes, products, services, and software through data analysis. Engage with business representatives and support the development of business requirements and deliver data-driven recommendations to enhance efficiency and add value.
Key Responsibilities- Participate in projects and operational changes to ensure compliance with industry standards and procedures.
- Create and update CSV deliverables for OT systems as per company procedures.
- Advise and direct site teams on industry best practices for the development of CSV protocols, including risk assessments, user requirements, functional specifications, and test qualifications.
- Engage with the in-house service of qualification engineers/technical writers to ensure consistency of documentation and compliance.
- Provide test management for the execution of qualification activities.
- Provide expertise and best practice on the use of electronic validation and lifecycle management tools for commissioning/qualification activities.
- Participate in CSV-related investigations and issue resolution, ensuring effective and timely remediation.
- Collaborate with Quality Assurance and e-Compliance teams to ensure CSV activities are in compliance with company procedures.
- Act as a data quality checker of the Master Equipment Inventory of all sites.
- Feedback on dedicated phases for project execution (quality, time).
- Degree of customization vs configuration of COTS solutions.
- Process efficiency (specific scope).
- Steady/uninterrupted process flow (specific scope).
- Completeness and accuracy of Business Process Model (BPM) - local or non-complex processes.
- Business process documentation up to date (specific scope).
- Work Experience: Bachelor's degree in Computer Science, Engineering, or a related field. Master's degree preferred.
- Minimum of 10 years of experience in computer system validation, with a focus on process automation systems.
- In-depth knowledge of regulatory requirements (e.g., FDA, GxP, 21 CFR Part 11) and industry best practices related to CSV.
- Strong understanding of software development lifecycle methodologies and their application to CSV activities.
- Excellent problem-solving and analytical skills, with the ability to identify and resolve complex CSV issues.
- Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and stakeholders at all levels of the organization.
- Detail-oriented mindset, with a focus on accuracy and compliance.
- Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.
- Certifications in CSV or related fields (e.g., GAMP 5, RAPS) are a plus.
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