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QA Senior Specialist New
1 month ago
Location: Swords, Co. Dublin
About Us
SK pharmteco is a global Contract Development and Manufacturing Organisation (CDMO) with state-of-the-art facilities in Korea, the 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 Small Molecule Europe facility, located in Swords, Co. Dublin, 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 and exceptional technical capabilities, we continue to deliver some of the world's most important medicines.
? Learn more: www.skpharmteco.com
Current Need
The Quality Team at the Swords campus is seeking a QA Senior Specialist on a permanent contract.
Position Description
This role is part of the QA Systems team and is responsible for managing site quality metrics, leading monthly Quality Management Reviews, coordinating audits and inspections, and supporting supplier qualification and licensing.
The position also provides QA systems support to the QA Systems Manager and team members, and serves as an advisor on NPI requirements for material qualification across development, clinical, and commercial manufacturing.
Reports to: Quality Systems and Validation Manager
Main Responsibilities:
- Collate Site Quality Metrics (weekly/monthly/annually) and monitor trends/actions
- Lead the monthly Site Quality Management Review
- Provide oversight of Supplier Qualification
- Act as back-room lead for all customer audits and regulatory inspections
- Participate in the internal Audit Team
- Serve as main point of contact for all licensing (e.g., HPRA ASR, scheduled substances, PMDA)
- Support assessment and QA approval of changes related to GMP compliance for facilities, utilities, labs, manufacturing equipment, and control systems (as needed)
- Review and approve GMP SOPs (as required)
- Ensure all activities comply with GMP regulations, site/corporate quality standards, and regulatory requirements
Other Responsibilities
- Manage Information: Monitor metrics and trends to ensure quality and compliance standards
- Teamwork: Build effective working relationships to achieve site objectives
- Manage Finances: Monitor and control licensing-related expenditures
- Safety: Always demonstrate Safety First principles
Minimum Requirements
- Bachelor's or Master's degree in Chemistry or a related scientific field
- Minimum 3 years of pharmaceutical industry experience in a similar QA role
- Ability to work independently and collaboratively across teams
- Must align with SK pharmteco Values and Behaviors
Desired/Advantageous Skills & Experience
- Previous experience generating Site Quality Metrics
- Background in Supplier Qualification
- Experience across clinical to commercial manufacturing
- Lean Six Sigma knowledge with proven system improvement results (e.g., metrics, digitalisation)
- Audit readiness and/or back-room support for regulatory inspections
Benefits
- Excellent opportunities for career growth and personal development
- Competitive base salary
- Annual bonus linked to business results
- Well-established further education program
- Pension scheme
- Private healthcare
