QA Lead Specialist

QA Lead Specialist

12 months contract position

Location: Swords Campus

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 Korea 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 SK pharmteco Ireland here at the Swords Campus are looking for a QA Lead Specialist on a 12 month contract basis.

Position Description:

The QA Lead Specialist is part of the QA team reporting and responsible for the QA elements of operational readiness to integrate a new plant/projects on site. Experience in similar large CAPEX projects within QA on Operational readiness is required with expert knowledge of PQS, QMS, Validation and Systems regulations. Previous experience from clinical through to commercial manufacturing experience is desirable. Providing QA support to the QA Manager as required. This role will report directly to the QA Manager.

Main responsibilities (including but not limited to):

·      Work with Key stakeholders to develop/execute a readiness plan to ensure all GMP aspects of the new Facility/Project are aligned, functional, and ready to support Business requirements.

·      Ensure integration of key GMP requirements including procedural controls, facility controls and training requirements to support on time transition from project phase to operational use in line with Project schedule and Site QMS.

·      Support Validation documentation as required.

·      Manage risk/identify potential gaps and implement strategies to mitigate them as relevant

·      Ensure that all activities are conducted to meet GMP regulations, site or corporate quality standards and any additional regulatory requirements.

Manage Information

·      Use of site documentation management system, deviation/CAPA/CC system and training systems.

Teamwork

·      Build effective working relationships to ensure site objectives are delivered on time in full and to the highest quality.

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 5 years of experience in the pharmaceutical industry in a similar role.
• The QA Lead 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 biotek Ireland Values and Behaviors.

Desired/Advantageous

Experience/skills in:

·      Previous experience in QA CAPEX projects

·      QA Operational readiness

·      Validation requirements and handovers

·      Systems experience

·      Experience in Clinical to commercial manufacturing

·      Lean Six Sigma – proven track record improving QA Operations/Systems/Validation processes

·      Experience in regulatory inspections or part of Inspection readiness team

#LI-NC3