Job Description
LSC is seeking a highly skilled QA Specialist to join a global Biopharmaceutical company in Carlow. This state-of-the-art vaccines and biologics manufacturing facility produces numerous products in various therapeutic areas, including oncology, autoimmunity, pneumonia, and infectious disease.
This is an excellent opportunity for individuals with 3 years of experience working in the pharmaceutical or biotechnology industry and ready for their next challenge.
About the Project - Key Responsibilities:
* Provide quality oversight and direction for the introduction of new products.
* Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
* Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
* Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
* Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation.
* Support deviation close out in a timely manner.
* Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
About You - Are Your Skills a Match?
* A Bachelor's degree or higher in a related Science discipline is preferred.
* A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
* Experience with equipment and process validation.
* Familiarity with sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications.
* Experience or familiarity with Lean Six Sigma methodology is desired.
* Proven ability to drive the completion of tasks.
* Strong decision-making capability with a sense of accountability and responsibility.
* Demonstrated problem-solving skills.