
IT Validation Specialist for Healthcare Products
hace 4 semanas
We are seeking a highly skilled IT Validation Specialist to join our team at ConvaTec Inc. This is an exciting opportunity to work with cutting-edge technology and make a real difference in the lives of patients.
As an IT Validation Specialist, you will be responsible for ensuring that all computerized systems used in the development, manufacture, and distribution of our healthcare products meet the highest standards of quality and regulatory compliance.
The estimated salary for this position is around $120,000 per year, based on industry standards and location.
Job DescriptionThis role requires strong technical skills, including experience with electronic software applications such as EDMS, PLM, QMS, LIMS, and ERP. You should have a good understanding of GxP regulations and best practices, as well as excellent communication and problem-solving skills.
- Evaluate proposed new computerized systems or software to assess GxP impact and provide guidance on risk-based validation approaches.
- Work closely with project managers to ensure compliance milestones are met during the project lifecycle.
- Develop and oversee validation deliverables, including validation plans, test plans, specifications, and design documents.
In addition to your technical expertise, you should be able to rapidly adapt to new situations and environments, influence and negotiate effectively, and handle a high concentration of work through successful multitasking and prioritizing.
Skills & QualificationsTo be successful in this role, you will need:
- A bachelor's degree in computer science, engineering, life science, or related field.
- At least 2 years' experience with equipment/process validation lifecycle management, validation documentation development, and pharmaceutical manufacturing or medical device industry experience.
- Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11.
- Excellent presentation and writing skills.
If you are a motivated and detail-oriented individual with a passion for ensuring the highest standards of quality and regulatory compliance, we encourage you to apply for this exciting opportunity.
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