- Coordination of testing and equipment schedules in the Laboratory.
- Scheduling adherence, sample shipments and reprocessing testing.
- Drive productivity initiatives focusing on analytical method improvement, minimizing cost and maintaining testing consistency.
- The QC Lead is the inspiration for continuous improvement, technology and innovation in the laboratory. This will include generation of CC cases, qualification and project management of new methodologies in the laboratory.
- Investigate deviations (both minor and major) for the supply chain testing with responsibility to interface with API technology and Quality specialists.. Focus on high quality investigations, meaningful corrective actions, and reducing the deviation generation rate. Determine appropriate corrective actions to prevent reoccurrence of the deviation. Ensure corrective actions are effective and improve right first time (RFT).
- Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports. As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
- Responsible for the update and maintenance of GMP documentation for the laboratory procedures - SOPs, and WI's. Ensure that documentation complies to GMP and EHS regulations.
- Support real time laboratory documentation review.
- Responsible for the training program for Analysts. The requirement is to ensure that there is a cross training program in place to develop Analysts, to provide full cross training cover for all testing and to allow for altered plans when abnormal variation occurs in the process.
- Participate in Regulatory Authority GMP inspections and audits.
- The QC Lead is responsible for CAPAs assigned to the laboratory process in LQT, eQuality and mai® systems. The closure of these actions has high priority for the role.
- Escalates issues to the management team for review and resolution.
- Ability to examine an issue from diverse perspectives (safety, compliance, analytical, automation, equipment, process, and people) in order to best understand and re-solve it at root cause. The QC Lead will use formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and other Lean Six Sigma tools to resolve deviations and variation in the Laboratory. They will document results in investigation reports or other formats.
- Ability to implement standard work flows and reduce variation in this workflow to match the production takt time.
- Responsibility for the day to day management of the QC Team.
- Minimum of 5 years' experience within the pharmaceutical industry in a QC team lead/supervisory role.
- A degree in a technical field such as science, biochemical sciences or equivalent scientific field is desired. Equivalent experience is also considered. Qualification or experience of biotechnology or bioprocessing is a plus.
- Strong commitment to promoting work place environment, health and safety.
- Familiarity with GMPs and regulatory requirements.
- Good knowledge of analytical methods and equipment, API processes and equipment, utilities and facilities in the heparin sodium and tinzaparin sodium.
- Strong problem-solving skills with a hands-on approach to trouble shooting, process optimisation and problem solving, with a bias toward going to see problems for oneself in the field as they arise.
- Professional and interpersonal communication skills are essential to be successful in this role.
- KPI reporting and the Visual Management boards around the site.
- Leadership with a strong bias towards operational excellence, a real ability to share best practice and implement good ideas from other areas in the Group is essential.
- Previous people leadership experience.
- Strong team player with the ability to work collaboratively and cross functionally.
- Excellent organisation skills
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