QA Lead Specialist

1 month ago

Dublin, Dublin City, Ireland Cpl Full time

ABOUT US?

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

Current Need:

The SK biotek Ireland Quality Team here at the Swords Campus are looking for a Quality Assurance Lead Specialist on a permanent contract.

Position Description:

· The QA Lead Specialist oversees critical quality activities including New Product Introduction and Capital projects, maintenance of key quality systems, and leading process validation studies.

· This role also involves being the main point of contact from QA with customers, managing a portfolio of customer quality activities, ensuring adherence to Annual Product Review schedules, and participating in audits by regulatory agencies and customers.

· Responsibilities include facilitating site investigations (including lab investigations), tracking investigations and CAPAs, and maintaining customer quality relationships.

· Additionally, the QA Lead Specialist addresses vendor non-conformances, and represents the company in customer meetings and cross-functional discussions.

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, preferably in a Quality Assurance role.

· The Quality Assurance Lead Specialist must possess strong initiative and be capable of working both independently and collaboratively within a team.

· The ideal candidate will demonstrate proficiency in the following areas: Excellence in communication, collaboration, working with minimum direction, 'can do, solutions orientated' attitude, leadership, problem solving and driving continuous improvement.

· Exceptional time management and organisational abilities, coupled with a track record of effectively handling multiple tasks and customers simultaneously.

· In-depth knowledge of cGMP principles relevant to API manufacturing.

· Adeptness in interpreting industry regulations and identifying potential gaps in current site and QA procedures.

· Capacity to manage numerous projects concurrently and meet strict deadlines.

· Strong troubleshooting skills and a sound technical background in quality within the pharmaceutical manufacturing sector.

Desired/Advantageous

· Experience/skills in: Customer Service, Project Management, Lean Six Sigma, Auditing/Auditor and QRM

Why choose a career at SK biotek?

· A chance to work with a world leader in contract development and manufacturing in a fast paced, dynamic growing company,

· Excellent opportunities for career enhancement and personal development.

· Hybrid working schedule.

· Competitive base salary.

· Annual bonus linked to base salary.

· A well-established further education program.

· Pension scheme.

· Private Health Insurance.

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