Job Description

Key Responsibilities:
• Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to 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.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigations and Deviations
• Participate in the generation and update of SOP’s, trend data, investigations, Deviations, 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.


Requirements

Qualifications:
• Excellent written and verbal communication skills
• Experience with TrackWise, Change Control Systems and EDMQ an advantage
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interaction with inspectors is preferable
• Experience leading cross-functional teams
• Experience working with teams and influencing decision
• Skilled in the use of problem-solving tools/techniques
Knowledge and Experience:
• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
• Strong background in Bioassays, Immunoassays and Cell Culture is essential.
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

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