LSC have a great contract opportunity for a Senior QA Validation Associate to join a Cork based Biopharmaceutical company.
If you have 5+ years of experience within a GMP environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* Key Subject Matter Expert (SME) and Quality Oversight representative in specific validation discipline(s).
* Maintains current knowledge of industry standards and regulatory requirements for validation techniques / approaches utilized at BioMarin.
* Supports the QA Validation group in maintaining regulatory compliance, in line with industry best-practices in specific validation discipline(s).
* Supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise.
* Supports strategy development and ensures regulatory compliance for validation projects. Strategically supports complex validation projects across a variety of disciplines.
* Provision of mentorship and SME support to more junior members of the QA Validation team and cross functional groups as applicable.
* Lead and represent QA Validation in multi-departmental meetings & project teams.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
EXPERIENCE
* +5 years' experience in a cGMP regulated manufacturing environment, with demonstrated knowledge of facility, equipment, utility, process, lab systems and CSV validation.
* Organizational and management skills to coordinate multi-discipline project groups
* Ability to speak, present data, and defend approaches in front of audiences and inspectors.
* Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
* Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
* Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
* Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
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 understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Siobhan Cummins at LSC on 021-4777329 if you have any more questions about this opportunity!
