Data Quality Assurance Specialist
7 days ago
About EMD Electronics
EMD Electronics is a leading global supplier of high-tech materials, services, and specialty chemicals for the electronics, automotive, and cosmetics industries. Our mission is to advance digital living by delivering innovative solutions that meet the evolving needs of our customers.
Your 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. Your role will impact a range of important customer, operational, project, or service activities within your team and related teams.
Key Responsibilities:
- Develop and implement computer systems validation strategies and plans to ensure compliance with regulatory requirements.
- Conduct thorough risk assessments and gap analyses to identify areas for improvement.
- Collaborate with cross-functional teams to design, develop, and implement software quality assurance processes.
- Provide training and support to colleagues on computer systems validation best practices.
- Travel occasionally to support global projects and initiatives.
Requirements:
- 4+ years of experience in validation, QA validation, validation testing, or related technical field within a pharmaceutical, life sciences, or biotechnology GXP environment.
- 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 Part 11).
- Ability to work with agility and implement change on local and global scales.
- Willingness to travel occasionally.
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