QA Specialist Senior Pharma

Salary(€):	0 - 0
Location:	Dublin
Ref:	103882

Quality Assurance Specialist –Senior – Pharma

To provide QA and Technical support globally, under the direction of the GQA Manager (Drug Product, Site GMP Support), to external suppliers of commercial drug product. To ensure that 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. To guide and develop colleagues / reports within GQA as appropriate.

Responsibilities

• To establish and maintain close working relationship with suppliers for drug product through, supplier improvement programs, regulatory inspection support and providing GMP support to Sites
• To assess GMP compliance of all 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.
• To ensure that Technical Agreements are established, maintained, implemented and revised regularly for all drug product suppliers
• To support execution of QMS and resulting related documents (including applicable complaints, deviations, investigations, Q-Infos, etc) to ensure compliance is achieved and maintained
• As applicable, provide QA support to the 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
• To provide appropriate leadership and support to QA related projects
• Support maintenance of 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 7 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

For immediate consideration and the opportunity of a potential interview please forward your CV application to laurentina@rftgroup.ie in strict confidence or contact Laurentina on 01 2302400.

RFT Group: Pharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the pharmaceutical, medical device, supply chain logistics and human resources.

We work in partnership with leading pharmaceutical, biotechnology, medical device, and chemical companies to recruit their key personnel. Our expertise is recruiting engineers, scientists and executives at all levels from graduate to senior director.