To ensure that products released to market conform to registered requirements and GMP. Responsible to Operational Quality Manger. As a QP certify batches according to EU GMP and make usage decisions so batches can be released to market. Provide support for investigations and deviations within the supply chain. Require experienced QP ideally with previous inhaled experience to ensure quick manufacturing license approval.
MAIN RESPONSIBILITIES To ensure that products released conforms to the required quality standards by reviewing Production and QA documentations. To take an informed decisions on the suitability of products to be released for sale. To ensure that any deviations from GMP or company standards in manufacturing/ packing operations are fully recorded so that appropriate actions may be taken to make improvements. To authorise rejection and reworking to product. To investigate these incidents and provide technical advice/ information to make improvements. To provide input on quality issues such as calibrations, maintenance, commissioning and validations of processes and we products through GSK R&D, Validation and Technical working parties and meetings. To control the introductions of change in established manufacturing or packaging processes by considering the effects of the proposed changes and instigating appropriate monitoring to assess the impact and using the appropriate control procedures. To authorise changes to process amendments, test standards and test methods. To conform formulations on the computer database after checking their compliance with source documentations. To continually appraise product monitoring and testing systems To liaise with other functions as appropriate when dealings with incidents affecting product quality. To technically approve Product stream Customer Compliant replies as required. To foster constructive relationships with support function personnel within and outside the Product Stream. To ensure safe working environment of practices within the area. To implement company and regulatory safety policies and standards.