QA Systems & Validation Manager

Cpl in partnership with SK biotek at the Swords Campus are looking for a QA Systems & Validation Manager on a permanent contract.

QA Systems & Validation Manager

SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to ‘make what matters for a healthy, happier world’, from grams to tonnes. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceuticals Ingredients (APIs), Highly Potent Active Pharmaceuticals Ingredients and Chemical Intermediates for almost 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 https://vimeo.com/skpharmteco .

Position Description:

The QA Systems and Validation Manager is responsible for the operations of the QA Systems (including Auditing and Compliance training) and Validation support activities, incorporating CAPEX projects and a portfolio of NPIs from development through clinical to commercial product manufacturing. This role will report directly to the Quality Assurance Associate Director and deputise for the Quality Assurance Associate Director as required.

Main responsibilities (including but not limited to):

·       Provide oversight of Site Change Control System.

·       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.

·       Ensure that all Equipment and Computer Systems are validated to the required cGMP standards and are maintained in a validated status.

·       Review and approve equipment and computer system Validation Master Plans, IQ and OQ protocols and reports.

·       Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.

·       Provide oversight of Site Document Management System and Compliance training.

·       Provide oversight on Site Internal Audit and Procedural Assessment Programs.

·       Lead the QA team in preparation for customer and regulatory inspections.

·       Manage the GMP interface with Maintenance, Warehouse, Technical Services and Utilities as required.

·       Ensuring that effective systems are used for maintaining and calibrating critical equipment.

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

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

·       Develop direct reports through coaching, mentoring, training and providing them with specialized projects, in line with performance connections process.

·       Recruit and train new team members as required.

·       Monitor and control use of resources.

·       Ensure that a culture of safety is implemented in QA by conducting safety reviews, risk assessments and monitoring compliance.

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 managing QA teams in the pharmaceutical industry.

·       The QA Systems and Validation Manager must possess strong initiative and be capable of working both independently and collaboratively across organisation.

·       The qualified candidate must demonstrate characteristics aligned with SK biotek Ireland Values and Behaviours.

Desired/Advantageous

Experience/skills in:

-           A CDMO environment- from Development, through clinical to commercial manufacturing

-           Project Management

-           Lean Six Sigma

-           Auditing/Auditor

-           QRM

-           Business and financial acumen (including CAPEX projects)

-           Digitalisation

Why choose a career at SK biotek?

A career with purpose and a chance to work with a world-leader in contract development and manufacturing in a fast-paced, dynamic, and growing organisation. Here at SK biotek Ireland, we believe we enhance patient’s lives and we need you! It reminds each one of us that what we do matters, and our mission is to ‘make what matters for a healthy, happier world’ - whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. By choosing a career with SK biotek Ireland, you'll join a team of passionate people working together to improve lives by making what matters for a healthy, happier world.

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.