Data Quality Assurance Specialist
3 weeks ago
About the Role:
As a Quality Specialist - Computer Systems Validation, you will be an integral part of the Global Systems Audit team within the Quality Assurance department at C Psystems. Your role will have a significant impact on various customer, operational, project, or service activities within your team and related teams. You will provide guidance and influence peers or management regarding technical issues and challenges, contributing to the technical or strategic direction and operational decision making in your specialization.
Key Responsibilities:
- Develop and maintain thorough knowledge of FDA and EU computer systems validation, including IT system development life cycle and software quality assurance in a regulated environment and associated regulations (cGMP, GLP, ICH, GAMP, Data Integrity, and Part11)
- Collaborate with various teams to identify and implement improvements
- Provide strong problem-solving, organizational, and communication skills to drive results
- Ability to work with agility and implement change on local and global scales
- Travel occasionally to support business needs
Requirements:
- Degree level or equivalent, preferably in a science or technical area
- 4+ years of experience in validation, QA validation, validation testing, or related technical field within a pharmaceutical, life sciences, or biotechnology GXP environment
- Strong technical skills and knowledge of computer systems validation
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced environment and adapt to changing priorities
What We Offer:
C Psystems is committed to accessibility in its workplaces, including during the job application process. We strive to create an inclusive environment where everyone can thrive. If you require accommodation during the application process, please contact our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
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