Responsibilities:

Leads team and provides support for new product introduction, new equipment and computer system introduction in line with regulatory requirements, corporate policies and site SOP’s.

Collaborates with both local and global project teams to assure quality of all validation activities performed at site to support release of medicinal products.

Sets priorities of team to ensure all validation activities are planned.

Coordinates and supervises team to ensure maintenance of validated status of site WRT Cleaning/packing/process validation/temperature mapping.

Provides coaching to team members to achieve individual and site goals.

Ensures planning schedules are met in order to achieve customer service.

Performs audit and inspection readiness preparation to meet HPRA, FDA, Regulatory requirements. Provides support in resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

Performs Quality review of documents.

Background:

• Thirs level degree in Pharmaceutical / Life Sciences
• Experience managing teams.
• Experience in a pharmaceutical Validation, Regulatory or QA environment.

• Experience of Regulatory inspections and customer audits.
• In depth knowledge and understanding for interpretation of cGMPs and Regulatory requirements.
• Good knowledge of report writing, Project Management, Continuous Improvement and problem solving tools.
• Understanding of production and laboratory systems to effect judgement decisions consistent with quality and business needs.
• Knowledge and understanding of validation requirements from process/ cleaning/ packing/ facility aspects/ systems.