We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
· 4 cycle shift role.
· Supporting the QC Team Leader during day to day operations of area.
· Testing for laboratory related projects e.g. analytical method transfers, equipment qualification, invalid assay and NC reduction initiatives etc.
· Performing In-Process testing using the following technology, UV, HPLC, Nephelometry, TOC, pH, Osmolality analysis.
· Performing Sample Management activities to support QC testing.
· Identifying and implementing laboratory process improvements leading to improved efficiency &/or compliance within area.
· Authors and investigates internal investigations, participates in regulatory inspections & external technical discussions etc.
· Keeping up to date with analytical technology and regulatory / compliance trends.
· Participates in technical groups to implement laboratory activities while following local and global regulatory requirements as well as standards.
· Supports the roll-out of laboratory activities (for example, instrument life-cycle management).
· Performs laboratory studies, projects, and processes/initiatives.
· Assists in developing lab strategies, policies, and guidelines linked to area of expertise (for example, authoring Standard Operating Procedures).
Education & Experience
· A BSc in Chemistry, Biochemistry or related Scientific discipline.
· 2+ years’ experience within a regulated biologics or pharma industry.
· Technical troubleshooting and problem-solving skills.
· Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or
· Be ambitious with excellent social, communication and partner management skills.
· Acute attention to detail.
· A focus on patients and customers at all times.