Senior Quality Assurance Specialist Job in Basingstoke RG291BY, Southern UK
PRIMARY ROLES
To provide QA and technical support in alignment with Shire Global Pharmaceutical Technology and Shire External Suppliers, in order to ensure Shire's commercial products are manufactured and developed (and where applicable, tested and packed also) in accordance with their Registered Approvals (eg NDA, MA) and Site Authorisations, and that the principles and guidelines of global GMPs are complied with at all times.
RESPONSIBILITIES
Job Function and Description
To perform the QA assessment of cGMP compliance for all QA activities related to the manufacturing processes (including packaging and testing where appropriate) carried out at Drug Product third party contractors
To assist in the QA and cGMP preparation, review and approval of quality related protocols and reports at Drug Product contract manufacturers to include -
• Validation / Revalidation activities
• Process improvements / Global Pharm Tech support
To ensure GMP compliance during validation and technical activities and identify quality issues, investigating and reporting these to Process and Validation GMP Team Management and Senior Management
To develop and maintain globally, good working relationships with key Shire contractors of Drug Product dosage forms
To develop and maintain good working relationships with other functions in GSC eg Global Pharmaceutical Technology, Materials and Logistics Management and Supplier Relationship Management
Review of Master batch documents and executed batch documents relating to activities above received from contractors and to liaise with contractors regarding any queries
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.