LSC have a great contact opportunity for a Senior QA Specialist – Packaging to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Engineering, Information Systems) and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide overall quality direction and oversight for key functional areas (i.e. Packaging, Process Development, Validation, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
o Quality review and approval of Validation and qualification documentation and SOPs to support site validation activities:
Review of DS & QRAES documents
Review of validation Plans, Protocols, IOQ, PQ and associated validation documents
Review of executed validation documents and reports
o Act as Quality point of contact and decision maker during New Packaging Product Introduction
o Technology Transfer and Process Validation activities whilst ensuring that all activities meet company and regulatory expectations.
o Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
o Provide Quality direction and input at Change Control and Deviation 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?
o University degree. Science or Engineering related discipline preferred.
o Understanding of principles of Validation and New Product Introduction
o Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
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!
To apply, submit your CV via this advert or contact Ciaran Murphy at LSC on 021-4777329 if you have anymore questions about this Senior QA Specialist – Packaging opportunity!