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Main Purpose
To primarily be the Quality leader for the MDI Pharmaceutical operation at thesite with overall responsibility for the quality of activities performed and materials produced in the MDI facility including line management of the quality control and quality assurance functions. To provide specialist knowledge, expertise and input related to quality assurance, regulatory compliance, cGMP, systems, processes and procedures for medical propellants and MDI business globally. To deploy personal competence and QA/QC experience to deliver customer support to internal and external customers, specific assigned projects and to support new pharma business initiatives.
Main Responsibilities
- Plan and coordinate QC laboratory and QA activities for agreed development projects.
- Supervise QC laboratory and Quality Assurance resources to execute projects within allotted budget and timelines.
- Ensure Quality procedures comply with required quality and safety standards and if necessary, develop procedures, experimental protocols and work instructions.
- Ensure QC test results and experimental data are provided to agreed schedules.
- Producetimely and accurate technical and management reports for presentation to management and customers.
- Review and recommend improvements to facility procedures, techniques and technologies.
- Identify and recommend training to team members when needed.
- Enforce company policies and safety regulations for operational efficiency.
- Contribute to the development of the site management system to support the manufacture of investigational medical products.
Qualifications
- Minimum: Degree or equivalent in a scientific discipline.
Knowledge/ Experience Required
- Experience of working in and leading both Quality Assurance and Quality control functions.
- Experience of GMP lab manufacturing operations ideally within the inhalation device sector including that required for Investigational Medicinal Products (IMP) manufacturing licence accreditation.
- Experience in the preparation of and hosting of both customer and regulatory audits.
- Experience of the development and operation of MDI analytical techniques.
- Knowledge of Pharmaceutical Quality System management.
