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QC Technical Specialist-Separation Sciences

Location: Dublin
Experience:7-9 Years
Job Type:Permanent
Salary:Not Disclosed
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QC Technical Specialist-Separation Sciences
Our client, a global Biopharmaceutical organisation are currently recruiting for a Technical Specialist to join their team on a permanent basis. As Technical Specialist you will lead, coordinate, facilitate, and undertake activities in relation to lab operations & compliance. You will provide technical expertise with a focus on method transfers, continuous improvement and implementing a lean culture and Right First Time (RFT).

• SME in a variety of analytical techniques including but not limited to HPLC, HIC, CE, UPLC and Mass Spectroscopy
• Plan and perform multiple, complex routine/ non-routine methods
• Responsible for providing technical guidance and applying expertise and critical thinking to independently resolve technical issues
• Lead training of staff on technical aspects of job as required
• Develop, revise and implement procedures that comply with appropriate regulatory requirements
• Experience of managing project groups and leading high performing teams and delivering results
• Qualification of analytical equipment and related testing functions
• Co-ordinate & plans activities related to the successful method transfers and optimisation of Separation Methods into the site
• Compliance with Standard Operating Procedures and Registered specifications
• Ensure the laboratory is operated in a safe manner
• Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures
• Keep up to date with current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing
• Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
• Participate in regulatory agency inspections as required
• Plan and implement procedures and systems to maximise operating efficiency
• Manage and contribute to the achievements of department productivity and quality goals
• Act as a change agent in support of continuous improvement

• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline
• 7+ years of experience in a pharmaceutical/healthcare Laboratory
• Proven experience of leading teams
• Strong background in Separation techniques e.g. HPLC, CE and Gel Electrophoresis
• UPLC and Mass Spectroscopy experience advantageous
• Analytical Technical Transfer experience essential
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
• Excellent written and verbal communication skills
• Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interacting with inspectors
• Experience leading cross-functional teams
• Experience working with teams and influencing decision making
• Skilled in the use of problem-solving tools/techniques

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252


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