The QC Biochemistry Team Leader will report directly to QC Manager and expect to work and manage the Biochemistry team under minimal supervision.
He/she will be responsible for the Laboratory testing of in process materials and finished product according to manufacturing schedule, regulatory standards and business timelines.
Responsibilities:
• Leading the biochemistry team in the Quality Control %28QC%29 department.
• Full responsibility for meeting the team’s goals, objectives and timelines, including: Biochemistry testing, workplans, raw material release etc.
• Accountable for the team’s professional performance in light of the regulatory guidelines and GMP.
• Leading, managing and implementing special projects.
• Working closely with internal interfaces e.g. production, operations, planning, R&D.
• Working closely with R&D to support development, troubleshooting, validation, and transfer of analytical methods.
• Writing and approval of quality documents, e.g. lab SOP’s, protocols, deviations, investigations etc.
Requirements:
• Relevant academic degree – a must .MSc – an advantage
• High level of English %28writing and reading%29 – a must
• Previous managerial experience / high level of managerial skills and qualities
• Experience and knowledge in QC analytics
• Knowledge in GMP and regulatory requirements %28FDA, EU, IMOH%29
• Previous experience in regulatory audits – an advantage
• Great communication and interpersonal skills
