Quality Systems Validation - Team Lead

Sigmar Recruitment

Dublin
€40,000-54,000 per year
Temporary
Full-time

16 days ago

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.

Quality Systems Validation - Team LeadWaterford Posted about 16 hours agoShare this jobSign up for job alertsYou agree to ourLatest JobsFull Time€40,000 - 54,000Full Time€40,000 - 54,000SkullbruFull Time€70,000WaterfordFull TimeNegotiableCorkFull Time€80,000Quick linksJobs in IrelandContact usDublin: +353 (0) 1 4744 600Athlone: +353 (0) 906 413973Cork: +353 (0) 21 431 5770Galway: +353 (0) 91 563 868 Email our team: info@sigmar.ieFollow us on socialSigmar Recruitment Consultants Ltd., is a private company limited by shares, registered in Ireland no. 353252, registered office 13 Hume Street, Dublin 2.

Sigmar Recruitment

Apply Now