Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
We have defined processes, procedures, and testing in place to build our Class II medical device systems. They are built compartmentally (in stages), inspected, tested, and ultimately, delivered, installed, and turned over to the customer.
Development and delivery of a close-loop validated process that ensures safe, consistent and effective production of a quality product (system).
The individual for this role will create a (gap/needs analysis) and a plan of action to achieve the Desired State (DS) as defined above. Minimally, this will involve a review of existing procedures, processes, and a hands-on approach to gain a full understanding of how our systems are manufactured.
Additionally, we have other processes (i.e. painting, welding, and possibly other processes that may require validation), of which, support is required.
After the gap/needs analysis is completed, the scope of the role is that of a traditional process validation specialist encompassing the following responsibilities.
Create detailed validation protocols that outline the procedures, acceptance criteria, and documentation requirements for process validation.
Perform risk assessments to identify potential process failures and their impact on product quality and patient safety.
Requirements:
Carry out validation activities, including Operational Qualification (OQ), and Performance Qualification (PQ), to ensure processes are capable of consistently producing quality products.
Collect and analyze data from validation studies to confirm that processes are operating within specified limits and producing products that meet quality standards.
Maintain comprehensive documentation of validation activities, including protocols, test results, deviations, and corrective actions. Prepare validation reports summarizing findings and conclusions.
Establish procedures for continuous monitoring and control of process parameters to ensure ongoing compliance with specifications and early detection of variations.
Ensure that personnel involved in the validation process are adequately trained and competent in performing their tasks.
Ensure that all validation activities comply with regulatory requirements, such as those outlined by the FDA in 21 CFR 820.751.
Review and evaluate deviations from established processes, implement corrective actions, and revalidate processes as necessary to maintain product quality.