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QA Product Specialist - United Kingdom  

Kyowa Kirin (company)


Posted on : 07 May 2017

Project Description

About us:
  • Our company is a leading biopharmaceutical company whose substantial reinvestment into R&D is creating products at both early and late stage development. 
  • With a focus on core business areas of oncology, nephrology, and immunology/allergy, our company  leverages antibody-related leading-edge technologies, including its POTELLIGENT Technology to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world
  • We are entering an exciting pre-launch phase with an array of development and in-licensed global products which will join an expanding, successful product portfolio, focusing on cancer supportive care, oncology and bone therapeutic areas.


Quality Assurance Product Specialist
We can offer a talented, diligent QA Professional the opportunity to join us at this outstanding time; providing QA support for the manufacture of our company's  International’s products in order to ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorizations, company operating policies and procedures, and business requirements. This will include:
  • Participation in project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance 
  • Prepare Technical Agreements and manage relationships with vendors and contract manufacturing organisation’s ensuring appropriate quality reviews and investigations are carried out    
  • Responsibility for one or more of the Quality System(s) - (Documentation Control, Change Control, Customer Complaints, Auditing, Training, Invoice Processing etc.) 
  • Manage QA aspects from change control to staff training along with following-up on customer complaints and review/approval of GMP documents 

About you:
  • Minimum life science degree essential 
  • Broad experience of working in Quality Assurance within the pharmaceutical industry essential 
  • Experience operating in a senior QA position at a manufacturing site to include sound knowledge of the principles of solid and semi-solid dosage manufacturing processes 
  • Proven experience reviewing and approving OOS investigations, deviations, change control and stability studies reports 
  • Demonstrable knowledge of GxP audits 
  • Excellent communication and interpersonal skills will be necessary in addition to strong analytical and problem solving skills