Principal Pharma Quality Engineer

ProClinicial, in support of our client, are seeking an individual to fill the role of Pharma Quality Engineer, based in Hudson, WI. The successful candidate will provide quality assurance expertise for the development, site transfer, manufacturing and testing of combination medical device/drug products and identify labeling requirements related to these products.

Responsibilities

• Provide support to all registered sites and/or drug projects to ensure excellence in quality and compliance for components and finished devices, including combination products
• Interface with all combination product manufacturing sites and implement best practices.
• Provide expertise for the continuous improvement of the quality system as it pertains to combination products and labeling.
• Establish and maintain a global strategy for preproduction and commercial manufacturing activities related to pharmaceutical projects.
• Participate in new product development risk and design.
• Implement systems and procedures that assure compliance with Quality Standards.
• Communicate significant issues or developments identified during quality activities and provide recommended process improvements to team or management.
• Review and approve test method validation and stability plans and reports.
• Provide technical support for laboratory testing to ensure root cause analysis of all issues identified by test and investigative results.
• Participate in supplier audits/assessments.
• Support internal and external site audits and inspections.
• Apply engineering concepts such as design of experiments, risk management, validation, methodical problem solving, and statistical analysis to drive continuous improvement activities.

Skills and Qualifications

• BS in quality, business, engineering field or other science/technical field and 10+ years of relevant experience.
• Solid understanding of cGMP guideline with an emphasis on quality standards, testing, compliance, facility, equipment and process qualification activities.
• Experience understanding proper documentation/quality requirements for a regulated environment.
• Experience and knowledge of USP, AAMI, global Quality System Regulations, or equivalent.
• Experience understanding proper documentation/quality requirements for a regulated environment.
• Well-developed interpersonal communication, decision-making and leadership skills.
• Able to work with internal and external customers.
• Ability to work in a collaborative and cross-functional team environment.
• Basic statistical knowledge and application.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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