Qualification & Validation Senior Specialist
Quva · Bloomsbury, NJ · Yesterday
On-siteQuality Assurance$65k–$89k/yrFull-time
About the role
The Qualification and Validation Senior Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include driving compliance with Qualification and Validation policies, procedures, and controls across all QuVa sites.
Responsibilities
- Drives compliance with Qualification and Validation policies, procedures, and controls across all QuVa sites.
- Authoring and reviewing qualification and validation master plans, commissioning documents, protocol content and execution strategy, ensuring compliance with corporate and regulatory standards.
- Supports site inspections from regulatory bodies, providing comprehensive technical background and history related to qualification and validation efforts.
- Writes and executes technical documents such as IQ’s, OQ’s, PQ’s, Engineering Studies, Summary Reports, Etc.
- Writes, evaluates, and resolves deviations that occur during protocol execution.
- Supports the proper continuous functionality of qualified/validated equipment and processes supporting the automation/facilities team when complicated issues occur.
- Onboards equipment to include evaluating the equipment criticality.
- Supports the automation/facilities team when complicated issues occur.
- Supports the proper continuous functionality of qualified/validated equipment and processes supporting the automation/facilities team when complicated issues occur.
- Supports the automation/facilities team when complicated issues occur.
- Supports the automation/facilities team when complicated issues occur.
- Supports the automation/facilities team when complicated issues occur.
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