Social network you want to login/join with:
- Serve as the first point of escalation for technical, compliance, and personnel problem resolution.
- Lead, plan, and coordinate routine team activities to meet business needs.
- Perform QC Chemistry analysis of incoming goods, in-process samples, intermediates, and finished product samples to Good Manufacturing Practice (GMP) standards.
- Conduct GMP analysis of stability samples.
- Complete, update, and review technical documentation, including analytical write-ups, standard operating procedures, and GMP forms.
- Verify and calibrate lab equipment.
- Maintain up-to-date training in line with GMP expectations.
- Manage QC chemical, reference standard, and consumable stock levels.
- Perform or coordinate QC batch release procedures and deliver lab throughput in line with the business plan.
- Manage and coordinate stability studies in compliance with business procedures and ICH guidelines.
- Maintain a thorough understanding of international regulatory requirements and act as a Subject Matter Expert during audits and inspections.
- Collaborate and coordinate initiatives with other QC Supervisors and Managers for improved compliance, efficiency, and working conditions.
- Identify and drive Practical Process Improvement (PPI) initiatives.
- Undertake ad-hoc activities as required by the business.
- Support and encourage a "Quality Culture" throughout QC.
- Deputize for the QC Manager in their absence.
Requirements:
- Degree in Chemistry or a strongly related scientific subject area, or equivalent experience.
- At least five years of relevant industrial experience.
- Extensive experience in instrumental and traditional analytical techniques.
- Supervisory experience is desirable.
- Effective communication skills at all internal and external levels.
- Proficient time management and project management skills.