- Analysis of incoming goods/in-process samples/intermediates/finished product samples to Good Manufacturing Practice (GMP) standards.
- GMP analysis of stability samples.
- Completion, update and review of technical documentation (including analytical write ups, standard operating procedures, GMP forms, specifications, investigations and reports).
- Verification/calibration of lab equipment.
- Maintenance of up-to-date training in-line with GMP expectations
- Management of QC chemical, reference standard and consumable stock levels.
- To perform or coordinate QC batch release procedures and deliver lab throughput in-line with the business plan.
- To manage and coordinate stability studies ensuring compliance with business procedures and ICH guidelines.
- To prepare, review or approve department technical documentation, as required including analytical and laboratory data for accuracy, completeness and compliance with documented procedures.
- To maintain a thorough understanding of international regulatory requirements (cGMP, Good QC Lab Practice, pharmacopoeial monographs/chapters, ICH guidelines) pertinent to the Section, and ensure all work within the Section is compliant. Act as a Subject Matter Expert with regulators / clients ( key part of audits and inspections) .
- Manage and deliver projects within the Department.
- To communicate effectively with others on site and internationally, and to participate with them in problem solving activities, as required.
- Collaborate and coordinate initiatives with other QC Supervisors and Managers for improved compliance, efficiency, HSE, working conditions etc.
- Identify and drive Practical Process Improvement (PPI) initiatives.
- Undertake/support Self-inspections, GEMBA walks and Huddle meetings.
- Undertake ad-hoc activities that may be required by the business.
- Support and encourage a "Quality Culture" and company 4i values throughout QC.
- Deputise for the QC Manager in their absence.
- To build rewarding, successful work environments and provide support and mentorship to your team ensuring high levels of performance, whilst following company procedures to ensure the team is managed in an effective way.
- To train others as required, to ensure that all section members are adequately trained, and appropriate training records are maintained.
- To complete People Management tasks for your team including, but not limited to: attracting and selecting new diverse talent, onboarding and training, setting clear goals and performance expectations, value inclusivity, providing open, timely and actionable feedback, conducting appraisals, setting an assessing the achievement of objectives, and development discussions.
- Understand emergency procedures and follow safe systems of work.
- Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times.
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
- Degree in Chemistry or strongly related scientific subject area.
- At least five years relevant industrial experience.
- Extensive experience of instrumental and traditional analytical techniques.
- Supervisory experience desirable.
- Effective communication skills at all internal and external levels.
- Proficient time management and project management skills to deliver to critical timelines whilst maintaining attention to detail.
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QC Section Head - Swindon, United Kingdom - Thermo Fisher Scientific
Description
:Act as first point of escalation for technical, compliance and personnel problem resolution.
To lead, plan, coordinate the routine team activities of the section to meet the needs of the business. The activities include (not fully comprehensive):
People Management:
EH&S:
Minimum Requirements/Qualifications:
We have a globally distributed team of more than 100,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
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