LSC have a great contract opportunity for a Plant and Technical QA Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 7+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations.
- Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities:
- Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet regulatory expectations.
- Provide Quality direction and input at Change Control Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes.
- Understanding of principles of Validation and New Product Introduction
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Ability to work independently and remotely with minimum direct supervision.
- Strong organisational, communication, coordination, and meeting facilitation skills.
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
