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QA Product Specialist Galashiels United Kingdom, United Kingdom,  

Kyowa Kirin (company)


Posted on : 19 June 2017

Project Description

Description:
  • Our company is a leading biopharmaceutical company with headquarters in Japan 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.
  • We can offer a talented, diligent quality Professional the opportunity to join us at this outstanding time; providing QA support for the manufacture of our company  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:
  • Graduate level life science degree essential, Post graduate qualification highly regarded 
  • Broad experience of working in Quality within the pharmaceutical industry essential 
  • Experience operating in a senior Quality position at a manufacturing site would be beneficial 
  • Exposure to reviewing and approving OOS investigations, deviations, change control and stability studies reports 
  • Knowledge of GxP audits 
  • Excellent communication and interpersonal skills will be necessary in addition to strong analytical and problem solving skills
  • You will be rewarded with an excellent package, commensurate to the level of this role.
  • This role will also offer you the opportunity of global travel.
  • Our company  is an equal opportunities employer.

Locations

Galashiels United KingdomScottish Borders United Kingdom

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