Quality Assurance Specialist - Global Pharma

Job Summary

Are you passionate about making a difference to patients’ lives? Do you want to build a strong career within a company that excels in delivering high quality research? Why not let our client realise your potential? Join one of the most successful, internationally recognised and established clinical teams in the industry.

Company Statement

Our client is one of the largest, most reputable clinical research orginisation who research, develop, manufacture and market their own products. They are a pioneer in leading edge research in drug trials and medical devices, they bring novel therapies to improve quality of patients’ lives around the world!

Responsibilities 

• Act as a deputy Responsible Person as defined in EU GDP Guideline 2013/C 343/01
• To perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder
• To ensure all products, personnel and third parties conform to local, EU and company quality assurance requirements
• Batch release, assess quality that each product is suitable for the country it is being released to (QA of documentation)
• To help checking the archiving system for QA topic
• Deviation, especially when considering temperature in transport

Qualifications

• Degree in a science/health-related subject.
• Fluency in written and spoken English
• Understanding of EU GDP, EU GMP and Quality Management Systems
• Ability to communicate and negotiate with peers  
• Understanding of local and European regulatory environment
• Good organizational, coordination, diplomatic, negotiation, presentation and communications skills
• Precise, rigorous and reliable with an analytical mind
• Good decision making skills
• Computer literacy
• Minimum 2-3 years in the pharmaceutical industry
• Experienced in handling regulatory interfaces such as inspections and audits would be andavantageous 

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age