This position has primary responsibility for providing Quality Assurance Compliance support to the following programs: validation, internal auditing, data review, product complaints, product lifecycle, investigation, CAPA, SOP, and Continuous Improvement. Develops and evaluates quality, system and process standards to ensure reliability and compliance with company standards and governmental and regulatory requirements.
Acts as SME and reference for others.
Bachelor’s degree in engineering, a scientific discipline or closely aligned field.
Three to five years of experience working in an FDA regulated industry, preferably in a quality discipline.
Demonstrated experience applying cGMPs and US FDA laws and requirements in an FDA regulated industry, preferably pharmaceutical.
Knowledge and experience in validation concepts (process, method, computer and cleaning), equipment qualification, product lifecycle, master record approval, internal auditing, data review, risk mitigation, investigations and CAPA planning.
Proven analytical and problem solving skills.
Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines.
ASQ Certification and statistical experience preferred.
Good communication, interpersonal, and technical writing skills.
Perrigo Company plc, a top five global over-the-counter (OTC) consumer goods and pharmaceutical company, offers consumers and customers high quality products at affordable prices. From its beginnings in 1887 as a packager of generic home remedies, Perrigo, headquartered in Ireland, has grown to become the world's largest manufacturer of OTC products and supplier of infant formulas for the store br...and market. The Company is also a leading provider of branded OTC products, generic extended topical prescription products and receives royalties from Multiple Sclerosis drug Tysabri®. Perrigo provides “Quality Affordable Healthcare Products®” across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other key markets including Israel and China.