Job Title : Regulatory Affairs Specialist
Location : Murrysville, PA
Position Summary
We are looking for a Regulatory Affairs Specialist and a Senior Supplier Quality Engineer to support critical manufacturing line transfer activities for Philips in Morrisville, PA. Both roles involve ensuring that all line transfer and quality activities are compliant with regulatory standards and support overall process improvement and validation during the transition.
Experience :
7+ years of experience in regulatory affairs with specific expertise in manufacturing line transfers .
Job Duties:
Support Manufacturing Line Transfer Activities : Ensure regulatory compliance during the line transfer process.
Quality Documentation : Assist in preparing and reviewing regulatory documents to ensure proper alignment with relevant regulatory standards.
Validation Activities : Participate in validation efforts such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) related to the line transfer process.
Trials and Statistical Techniques : Assist in the design and analysis of trials and validation using appropriate statistical methods.
Control Variables : Ensure that appropriate control variables are identified, measured, and managed during validation and line transfer processes.
Engineering Change Management : Support engineering change control processes, including the creation and management of engineering documents.
NCRs and CAPAs : Assist in identifying and addressing Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) as required.
Required Qualifications:
Bachelor's degree in a relevant field (Engineering, Regulatory Affairs, or similar).
7+ years of experience in regulatory affairs with a focus on manufacturing line transfers .
Strong understanding of validation activities including IQ, OQ, and PQ.
Experience with engineering change management and document control .