Back to Job Search

Senior Quality Assurance Lead

  • Sector: Science & Pharma
  • Contact Email: ranait.coughlan@collinsmcnicholas.ie
  • Job Ref: 19844

We have an exciting opportunity for a Quality Assurance Lead to oversee the Drug Product Manufacturing onsite for our Client, A Global Pharmaceutical Manufacturer that focuses on Human Vaccine Discovery, Development and Manufacturing. This is a full time Permanent job based in Dundalk, Co. Louth. This is a unique opportunity for an experienced QA to work in a brand new facility on a Greenfield Site.

Responsibilities:

  • Act as site QA to be responsible of on site quality monitoring of DP manufacturing and participant in GMP production activities, such as process transfer, validation etc.
  • Close monitoring the construction quality of GMP production.
  • Work with functional department to create department SOPs and assure alignment between the vaccines and biologics facility.
  • Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective.
  • The lead of QA for DP will be responsible for setting up online DP QA team in Dundalk.
  • Work closely with other team, to support all GMP production activities.
  • Perform routine audit for manufacturing area, to assure GMP production in compliance with all regulatory, market, EU, FDA and company standards
  • Be accountable to review and approve manufacturing generated documents, include but not limited: qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, change control, QRM, etc..
  • Ensure accurate reporting of MFG generated results and assure data integrity in daily activity. 
  • Train team members as required to meet the demand of company fast growth.  
  • Responsible for managing a team of employees across QA for DP in ensuring all associated performance management requirements are in place for each employee and relevant reviews are carried out regularly. 
  • Responsible for organising relevant training for employees who carry out DP online duties to ensure site SOPs are followed, accurate identification of deviations or any other quality issues. 
  • Liaise actively with cross functional teams when release DP 

Requirements:

  •        Knowledgeable of legislative, regulatory, market, biologics and data integrity requirements.
  •        Experience with Drug Product Formulation, sterility, glass freezer, micro contamination and line filling experience is highly desirable
  •        Degree in Biopharma or related science discipline is desired
  •        Min 5 Yrs  experience in a vaccine / bio pharma /drug product formulation industry
  •        Min 1Yr experience in a managerial / leadership role
  •        Strong communication skills is essential and experience working in a matrix environment is desirable

For a confidential discussion about this opportunity please contact Ranait Coughlan

ranait.coughlan@collinsmcnicholas.ie

(090) 6450664 (01) 66 200 88