Plant & Technical Senior QA Specialist (BBBH28023) Dublin, Republic of Ireland
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.
* PPQ, tech transfer and Quality oversight.
* 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.
#J-18808-Ljbffr