perrigo company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. help us do it.
at perrigo our mission is clear: we seek to provide quality affordable Healthcare products. with over $5.5 billion in Sales and more than 10,000 people working around the world, perrigo company is a leading global self-care supplier.
main purpose of the role is to support Compliance activities on site, working within the qa department. the successful candidate will work within the qp team to support batch disposition activities and to support Quality Systems to ensure the site remains compliant with current GMP requirements. supplier management and the oversight of the Internal Audit program are key components to the role. the role will also involve taking the lead in various product categories, supporting technical transfer activities and providing general Compliance support to the site.
responsibilities of the role include:
- perform duties of a Qualified Person as defined by directive 2001/83/ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use.
- assume ownership for and drive the perrigo batch disposition process, including review of third-party batch paperwork.
- provide qp input to key Quality Systems: Change Control, customer complaints, pqrs, product investigations, ra strategies, supplier management and technical transfers (this list is not exhaustive).
- participate in project category meetings and be a senior Compliance Leader and Advisor to the site, ensuring Compliance requirements and implications are always core to the decisions taken by the business.
- work cross functionally to ensure that the site retains its license to operate and that Compliance continues to be held as a core focus area across the site.
- assist in supporting operational Compliance by applying quality Risk Management tools and principles in assessments and investigations, in order to support Compliance decisions. this support is provided both formally in investigation meetings/ document reviews and also on an ad hoc basis via on the floor conversations with stakeholders at all levels of the business.
- responsible for maintaining an effective recall process on site.
- responsible for championing Compliance standards on site, working with stakeholders to ensure that quality standards are maintained and opportunities for improvement, once identified, are actioned.
- manage department-level projects/ initiatives, as assigned, e.g. continuous-improvement projects based on the Quality System.
- conduct both internal and external audits as required.
- provide guidance and mentorship to other qa department members and to work closely with the other perrigo qp’s to ensure that the qp group are an authoritative and supportive Expert group.
- hosting customer audits and assist in the preparation and participation in inspections.
- in addition to the duties and responsibilities listed, the jobholder is required to perform other duties assigned by your manager or other senior site personnel from time to time.
requirements for the role include:
the successful candidate will have a Pharmacy degree Qualification with several years of experience in the Pharmaceutical Industry. the candidate must be eligible for being named on a Manufacturing license as a Qualified Person. this experience must include previous experience in internal and external Auditing, and operational support in a qa role. experience in the application of quality Risk Management tools is a requirement. experience in management of department-level projects would be advantageous. the successful candidate is expected to demonstrate a keen interest in current trends within the industry and how these trends can be actively adapted into site improvements. this role will appeal to an energetic and self-driven professional who is willing to both lead and participate in group activities in order to achieve company successes.
we're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. different makes us better.
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