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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

QA Packaging Manager/QP


Reference:SCANLD-162040 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person, Quality Auditor

QA Packaging Manager/QP
Our client, a global healthcare company with operations based in Dublin are currently recruiting for a QA Packaging Manager/QP to join their team on a permanent basis. As QA Packaging Manager/QP you will be responsible for a range of GMP and product release support for secondary packaging activities which can include Quality batch documentation review and control, review and approval of controlled documents including batch records and SOPs, quality performance reporting, and support of investigations, complaints and projects.

Responsibilities

  • Daily briefing on Quality batch review/approval
  • Provide quality performance information as required
  • Ensure regular Quality interaction with other Departments and other sites
  • Product release (packaging step)
  • Establish and manage a Quality Team able to perform the following duties:
    • Quality Assurance program to maintain cGMP compliance including deviations and CAPA management
    • In process quality checks for packaging operations
    • Product release of packaged product
    • Manage all laboratory activities for post packaging ID testing of finished product and Quality approval of ID testing results for finished product
    • Support product recall activities
  • Generation of annual product quality reviews
  • Support the process change control system
  • Support the quality audit/inspection programmes
  • Process/product/system improvement projects
  • Drive and oversee process/product/OOS investigations (including planned / unplanned deviation)
  • Training of new Quality personnel
  • Review and Approval of Batch records and SOPs, GMP implementation and site-wide Quality Awareness
  • Facilitate Inspections by third parties, e.g. HPRA, FDA, customers, etc
  • Responsible for follow up corrective actions identified through the Deviation system
  • Liaise with other Department representatives to promote improvements in GMP and Quality standards
  • Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activitie
  • Participating in the Self inspection program
Requirements

  • Minimum of 10 years relevant experience in the pharmaceutical sector
  • MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status
  • QP on-licence experience of minimum 2 years
  • Lead Auditor Certified
  • Excellent verbal and written communications
  • Strong interpersonal skills to interact with all levels of personnel in a professional manner
  • Have a strong quality and compliance background in the pharmaceutical industry
  • Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates
  • Strong decision- making skills
  • Ability to manage multiple projects simultaneously, meet deadlines
  • Lead Auditor Certified