Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
This position, reporting to the Associate Director Third Party Quality, will support the Third Party and Commercial Quality team, their primary focus; to enhance and maintain the quality oversight and compliance systems of Third Party contractors. This position will primarily be involved in supporting and coordinating day to day activities including Batch Record Review, SOP, Change Control, Deviation and CAPA management. The position will also support Quality Supply Chain oversight including ensuring Quality Agreements are in place and up to date as well the maintenance of product Supply Chain Maps for product within the TPQC portfolio.
Primary duties and responsibilities of the position are as follows. Other duties may be assigned.
- Responsible for day to day activities designed to maintain and enhance the local Quality Management System for 3rd Party and Commercial oversight in line with directive 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively ,Medical Device Directives, ISO13485 as applicable.
- Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures
- Effective management and coordination of Quality Management Systems including change control, Deviations, CAPA, SOP’s.
- Interface between Regulatory Affairs, Marketing and Customer Service personnel where necessary.
- Management of customer complaints, Adverse Event reports and Medical Information enquiries and forwarding to relevant parties for processing.
- Responsible for the writing, training and management of SOPs including associated training requirements
- Maintenance of system to ensure appropriate review and completion of Annual Product Quality Reviews
- Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required
- Coordinating quality related customer complaints , where necessary liaising with other Allergan quality team to close such complaints as applicable
- Provide direct support during competent authority audits
- Assist in conducting internal self-inspections and external audits as appropriate
- Quality review and approval of artwork components where applicable
- Review and co-ordination of batch records and associated documentation including the generation of product certificates to support batch release and certification of product
- Bachelor’s Degree required. Chemistry or Life Science degree preferred. Some exceptions made for those candidates demonstrating equivalent knowledge and having pharmaceutical experience.
- Minimum of 3 years’ experience in QA/Compliance in pharmaceuticals or related industry.
- Prior pharmaceutical or quality assurance experience essential
- Strong analytical skills and knowledge of quality system essential
- Thorough knowledge of either EU GMPs and/or Medical Device Directives
- Demonstrated written and verbal communication skills.
- Good communicator both verbally and written with strong interpersonal skills
- Ability to manage virtual organisations and report effectively to internal management.
- Computer literate essential including working knowledge of MRP system.
Allergan is 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, protected veteran status, disability, or any other protected status.