Job Description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to win in self-care.
Description Overview
1 year Fixed Term Contract Role.
In this role you will be responsible for supporting GDP compliance of Omega Pharma Limited in accordance with the general conditions of the Wholesale Distribution Authorisation (WDA) and applicable current requirements of Good Distribution Practice (GDP).
You will also support with GMP compliance of Omega Pharma Limited in accordance with the general Conditions of the Manufacturing and Import Authorisation (MIA) and applicable current requirements of Good Manufacturing Practice (GMP).
Another key responsibility in this role will be to support quality, system and process standards to ensure reliability and compliance with company standards and governmental and regulatory requirements such as EU GDP Directive 2013/C 343/EU, Human Medicines Regulation 2012 and EU 2001/83/EU.
It will also be your responsibility to act as an RPi delegate, releasing medicinal products to the market for OPL.
Scope of the Role

• Releases medicinal products to the market for the OPL business as RPi delegate. Ensuring product is safe for patients and any investigations are completed use risk-based processes.
• Support quality systems on site such for the raising of Change Controls, Deviations, CAPAs as required, writing SOPs.
• Acts as Quality Lead on business projects.
• Oversee routine + ad hoc rework processes, approve BOMs and manage FSDU/Display Pack Projects.
• Manage the Periodic Quality Review programme, preparing the OPL QA reviews and ensuring schedule adherence.
• Supplier and Customer qualification and maintenance including annual bona tides and monthly GMDP compliance checks.
• Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.

Experience Required

• Scientific University Degree or equivalent
• Minimum of 5 years' experience in a GDP Quality Assurance Role in the Pharmaceutical Industry.
• Good understanding of EU GDP/GMP
• Ability to maintain high quality documentation, manage data sources and interpret data for key Performance Indicators to judge the operational state of processes
• Work independently on QMS elements they are responsible - knowing when to escalate appropriately any issues.
• Experience using electronic documentation systems e.g., Trackwise, SAP
• Comprehensive understanding of GMP, GDP, regulatory (UK Human Medicines, MHRA) and broader EU / PICS/ISO requirements for pharmaceuticals, cosmetics, biocides, food supplements & medical devices together with experience direct experience of dealing with regulatory agencies on quality and compliance matters.
• Thorough knowledge of technical and commercial requirements of the business associated with the Quality units' activities, role and resource. Acts as consulting expert in the quality field for complex issues associated with quality, technical and regulatory requirements for the business, especially as they relate to GDP.

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about at Perrigo.
Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.
We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo

Skills Required