Regulatory Compliance Specialist
6 days ago
About the Role:
Katalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a Validation Specialist, you will be responsible for ensuring the quality and integrity of our products by validating processes and equipment.
Key Responsibilities:
- Process Validation: Develop and execute process validation protocols to ensure the quality and consistency of our products.
- Equipment Validation: Validate equipment and systems to ensure they meet regulatory requirements and are functioning correctly.
- Documentation and Reporting: Create and maintain accurate and detailed documentation of validation activities, including protocols, reports, and records.
- Collaboration and Communication: Work closely with cross-functional teams, including engineering, quality, and operations, to ensure seamless execution of validation activities.
- Regulatory Compliance: Ensure that all validation activities are conducted in accordance with relevant regulatory requirements, including FDA and cGMP regulations.
Requirements:
- Education: Bachelor's degree in Engineering, Science, or equivalent technical degree.
- Experience: 3-5+ years of experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
- Skills: Excellent written and verbal communication skills, strong interpersonal skills, and ability to work in a team environment.
- Technical Skills: Proficient in Microsoft Word, Excel, and PowerPoint, and experience with statistical tools and software, such as MiniTab.
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