Cpl in partnership with SK pharmteco are hiring a permanent QA Senior Specialist to join QA Systems team for their site in Swords, Co. Dublin.
ABOUT US?
SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korean company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver life-changing therapies that improve patient outcomes and save lives’. The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at www.skpharmteco.com
Current Need:
The Quality Team at the Swords campus are looking for a QA Senior Specialist on a permanent contract.
Position Description:
The QA Senior Specialist is part of the QA Systems team and responsible for the operations of Site Quality metrics, leading monthly Quality Management Review, back-room lead for all audits and inspections, part of the internal Audit team, Supplier qualification and licensing. Providing QA systems support to the QA Systems Manager and team members as required. Advisor on NPI requirements for material qualification from development through clinical to commercial product manufacturing. This role will report directly to the Quality Systems and Validation Manager.
Main responsibilities (including but not limited to):
· Collate the Site Quality Metrics (weekly/monthly/annually) and monitoring trends with actions.
· Lead the monthly Site Quality Management Review.
· Provide oversight of Supplier qualification.
· Back-room lead for all customer audits and regulatory inspections.
· Part of the internal Audit team on site.
· Main point of contract for all licensing i.e. HPRA ASR, scheduled substances, PMDA etc.
· Assist with Assessment and QA Approval of changes for GMP compliance in accordance with change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes (where required).
· Review and approval of GMP SOPs (where required).
· Ensure that all activities are conducted to meet GMP regulations, site or corporate quality standards and any additional regulatory requirements.
Manage Information
· Metrics and trending to ensure quality and compliance standards are monitored.
Teamwork
· Build effective working relationships to ensure site objectives are delivered on time and to the highest quality.
Manage Finances
· Monitor and control use of finances for licensing.
Safety
· Demonstrate Safety first principles at all times.
Minimum Requirements:
· A Bachelor's or Master's degree in Chemistry or a related scientific field is required, with a minimum of 3 years of experience in the pharmaceutical industry in a similar role.
· The QA Senior Specialist must possess strong initiative and be capable of working both independently and collaboratively across the organization.
· The qualified candidate must demonstrate characteristics aligned with SK pharmteco Values and Behaviours.
Desired/Advantageous
· Previous experience in QA Systems generating Site Quality Metrics.
· Previous experience in Supplier Qualification.
· Experience in Clinical to commercial manufacturing.
· Lean Six Sigma – proven track record improving Systems processes e.g. Metric generation, Supplier Qualification and/or Digitalisation.
· Experience in back room for regulatory inspections or part of Inspection readiness team.
Other Benefits Include:
· Excellent opportunities for career enhancement and personal development.
· Competitive base salary.
· Annual bonus linked to business results.
· A well-established further education program.
· Pension scheme.
· Private healthcare.