Director of Quality | Dublin North | Permanent |
DIRECTOR OF QUALITY | NORTH DUBLIN | PERMANENT |
THE CLIENT |
Located in North Dublin, our international client provides full manufacturing services within the Pharma Industry. They are industry leaders committed to growing its business, contributing to its local community and developing its people. To grow and get better, not just bigger, requires strong organisational capability, and the right people in the right jobs. Staffline Ireland is currently searching for a Director of Quality to join their team on a Permanent basis.
THE ROLE |
The successful Director of Quality will be responsible for all quality and regulatory aspects within all projects on their site in Dublin. Teams from Quality Operations including Quality Control and Regulatory and QA Validation will report to the new team member.
- Member of the Site Leadership Team which decides and implements strategy and direction
- Provide a Quality and Regulatory Function to the business unit in order to support operational, commercial and business development functions across the site
- Development, maintenance and standardisation of quality ways of working including but not limited to databases, specifications, templates, SOP's and training
- Authorisation and Approval of Change Records, Validations and Qualifications.
- Communication with Competent Authorities as and when required.
- Leading preparation for and hosting of regulatory and Corporate Quality inspections.
- Review and approval of all Regulatory Filings.
- Governance of all External and Internal audit programmes and plan, executing and following up on supplier site visits
- Management responsibilities for their project team members and ensuring that all KPIs, targets and any other deadlines are met individually and by the team.
- Provide internal and external customer and supplier status reporting including but not limited to Issue and Risks, Budget control, performance and schedule adherence.
- In conjunction with the operational group assist in technical, product and process reviews to resolve operational, performance and functional issues.
- Minimum 5 years experience in similar role with additional previous experience as a QA in Pharma Industry
- Degree qualification in Science/ Chemistry/ Bio Tech
- Extensive experience in cGMP systems, pharmaceutical manufacturing and testing experience
- Regulatory inspection experience leading a function or group
- Strong experience in Pharmaceutical Project Management as well as managing or supervising teams required
- Qualified Person accreditation with previous experience as a named QP for a licensed facility is desirable but not essential
- Quality Control Laboratory experience
- Ability to identify and drive continuous quality improvement - Six Sigma Black Belt or Lean Certification or Prince 2 (or equivalent) project management qualification an advantage
WHY USE STAFFLINE IRELAND?
On 1st of July Grafton Recruitment Ireland became Staffline Recruitment Ireland
This may not matter to you when you're looking for a new opportunity, but we just wanted to tell you a little bit about us. We know that finding the right job can be challenging and we have the tools and resources to help you succeed. We are a leading recruitment agency offering a full recruitment solution throughout the island of Ireland and across the UK. We have branches across the island including Swords, Walkinstown and Cork with an expansion to Galway and Dundalk under way. Whether it's temporary contracts or permanent employment, you can be sure that Staffline Ireland will have the right career for you.
For all of our latest opportunities please go to our website www.staffline.ie
Thank you for reading the above, should you wish to apply for the role, please send your CV via the link to Lisa McCormack in the Swords Branch.