Senior QA Specialist

CAREERWISE RECRUITMENT

CORK

EXCELLENT BIOPHARMA OPPORTUNITY - We require a number of Senior QA Specialist for our Cork based trailblazing biopharma client. Calling all those with Pharma or Med Devices experience. Join a leading multinational currently expanding their team today. THE ROLE: * The Senior QA Specialist (Distribution team) will work closely with the rest of the Quality - Distribution team to ensure Good Distribution Practices (GDP) compliance as it relates to the supply of drug products to end customers via Affiliates, commercial distributors and Access Operations & Emerging Markets (AOEM) distributors. Details of duties include: * Provide routine support to partners (e.g., affiliates; AOEM operations) in the area of GDP compliance. * Generate and maintain Quality Agreements with Affiliates/ 3rd party Distributors. * Documentation review & approval for in-market GMP/GDP activities performed by 3rd parties. * Lead and/or participate in small cross-functional working groups to deliver processes & procedures under the Corporate Support Model initiative for the EU and ROW Affiliates. * Maintains programs and processes to ensure high quality products delivered to customers and compliance with current Good Distribution Practices (GDPs. * Collaborate cross-functionally with local and global colleagues (Supply Chain, Commercial Operations, Corporate Quality, Customer Service) to identify and implement process improvements in distribution of raw materials and finished products. * Participate in internal and external compliance audits as required, including audits of potential new distributors and on-site visits. * Lead or co-ordinate investigations and corrective and preventative action recommendations related to product supply chain. * Participate in inter-site global projects in the area of distribution of APIs and Finished Products. * Support regulatory inspections as required. * Support the annual product recall challenge & participate in product recall, as required. REQUIREMENTS: * 3 years of relevant experience in the pharmaceutical industry and a BS or BA. * Ability to work on own initiative as well as display strong teamwork skills. * Demonstrates proficiency in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP. * Demonstrates excellent knowledge of regulations and guidelines associated with distribution supply chain of medicinal products and APIs. * Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards. Please call Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1682 days ago