Sr. Quality Assurance Specialist, Drug Product Job in Pennsylvania 19087, Pennsylvania Us
Sr. Quality Assurance Specialist, Drug Product
Primary Role
To provide QA and Technical support globally, under the direction of the GQA Manager (Drug Product, Site GMP Support), to Shire's external suppliers of commercial drug product. To ensure that Shire's products are manufactured and in compliance with their Registered approvals (NDA or MA), national or European, and the principles and guidelines of current Good Manufacturing Practices (as laid down in Directive 2003/94/EC, 21CFR, and applicable regulatory requirements). To guide and develop colleagues / reports within GQA as appropriate.
Responsibilities
- (25%) To establish and maintain close working relationship with Shire suppliers for drug product (DP) through, supplier improvement programs, regulatory inspection support and providing GMP support to Sites
- (20%) To assess GMP compliance of all Shire drug product suppliers through audits to ensure effective Quality Systems are in place to maintain compliance with the principles of GMP, as laid down in the relevant EC, US or national laws and guidelines.
- (20%) To ensure that Technical Agreements are established, maintained, implemented and revised regularly for all Shire drug product suppliers
- (20%) To support execution of QMS and resulting related documents (including applicable complaints, deviations, investigations, Q-Infos, etc) to ensure compliance is achieved and maintained
- (5%) As applicable, provide QA support to the Shire Affiliates and new business opportunities (including new product introduction and line extensions), to ensure Site GMP aspects are covered and potential quality issues are identified and reported to Senior Management
- (5%) To provide appropriate leadership and support to QA related projects
- (5%) Support maintenance of Shire electronic systems to ensure compliance is achieved and maintained
Education Experience Requirements
- University degree in Chemistry, Pharmacy, Biology or other related scientific discipline
- Practical experience for at least 4 years in the Pharmaceutical industry in manufacturing / technical / QA or QC role(s)
- Good working knowledge of US cGMPs, EU cGMPs and familiar with other International GMP standards e.g. Health Canada, ICH and experience applying the knowledge to supplier audits and technical agreements
- Demonstrate success in working in multifunctional teams
0
December 15, 2010
• Tags: Drug Product Job in Pennsylvania 19087, Pennsylvania Us, Sr. Quality Assurance Specialist • Posted in: General