Cpl, in partnership with SK biotek, is looking to hire a QA Lead Specialist on a 12 month contract, to join the team in the Swords Campus, North Dublin. 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 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 here at the Swords Campus are looking for a Quality Assurance Lead Specialist on a 12 month 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.
Requirements: A Bachelor's or Master's degree in Chemistry or a related scientific field is required, with ideally a minimum of 10 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:Experience in API manufacturing from NPI through to commercialisation (end to end product lifecycle).In-depth knowledge of cGMP principles relevant to API manufacturing.Knowledge of regulatory requirements, trends, hot topics and emerging requirements.Strong awareness of the CDMO business environment and financial acumen.Exceptional time management and organizational abilities, coupled with a track record of effectively handling multiple tasks and customers simultaneously.Excellence in communication, collaboration, working with minimum direction, 'can do, solutions orientated' attitude, leadership, problem solving and driving continuous improvement.Proficiency 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 ServicesProject ManagementLean Six SigmaQRM
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