LSC have a great contract opportunity for a QA Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Gráinne Hodnett at LSC on 021 4777329 if you have any more questions about this role!
