SK biotek Ireland, a SK pharmteco company, is a global Contract Development & Manufacturing Company with state-of-the-art facilities in Korea and Ireland. We are part of the wider SK Holdings group with revenues of $95 billion in 2020. Our mission is to ‘make what matters’, from grams to tonnes, the Swords Campus has led the way in the development, scale-up and commercial manufacture of highly potent Chemical Intermediates and Active Pharmaceuticals Ingredients (APIs) for over 50 + years. With exceptional technical capabilities, people and plant we have made some of the world’s most important medicines and continue to do so. Further information on how we ‘make what matters’ can be found at https://vimeo.com/skpharmteco.
SK biotek Ireland is seeking to hire a Quality Assurance System and Validation Manager on a permanent basis. This a D06 position. Reporting to the Quality Director, the successful candidate will play a lead role in the Quality Management team, providing compliance leadership across the site ensuring the site operates to the applicable cGMP and international standards for our customers on a daily basis.
WHAT WILL YOU DO?
As an owner of key GMP quality systems your responsibilities include but are not limited to:
• Leading a team of specialists including contractors to support develop and maintain the site pharmaceutical quality system.
• Managing of team responsible for GMP electronic systems including but not limited to the site quality management system, electronic document system and laboratory information management system. Engaging with stakeholders to ensure maximum effectiveness of systems.
• Managing the site change control and CAPA systems, GMP aspects of the site training plan and lifecycle management of documentation
• Review and approval of GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.
• Ensure that all Equipment and Computer Systems are validated to the required cGMP standards and are maintained in a validated status.
• Own the internal Audit programme and site preparations for Health Authority and customer Inspections.
• Drive the development and implementation of new techniques, systems and initiatives to enhance the quality system on site. Champion continuous improvement with particular focus on right first time and lean methodologies
• Management review of the PQS.
The successful candidate will possess strong Quality and People Management. The candidate must have a strong understanding of the key business drivers of the industry/organization. Candidates should hold at minimum a Bachelor’s Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable and at least 8 years’ experience in the Pharmaceutical industry.
Excellent communication and organisational skills with demonstrated expertise to effectively communicate within all levels of the organisation is required. Demonstrated ability to lead, cross functional teams and make decisions in pressurised situations to ensure compliance.
WHATS IN IT FOR YOU?
• A chance to work with a world leader in contract development and manufacturing in a fast passed, dynamic and growing company
• Excellent opportunities for career enhancement and personal development
• Competitive base salary
• Annual bonus linked to base salary
• A well-established further education program.
• Pension scheme
• Private health insurance
• Free onsite parking
• Subsidized canteen on site