The Qualified Person will need to ensure that all activities are in compliance with current Good Manufacturing Practice standards and in accordance with company policies to meet business requirements.
The Qualified Person will be required to work with Manufacturing, Quality Control and Engineering team to provide technical expertise in the resolution of quality issues.
The role holder will also be required to support the QA function at our other Advanced Accelerator Applications sites and provide support to other Spanish manufacturing sites as required.
To comply with the Code of Practice for Qualified Persons in the Pharmaceutical Industry.
To assist in ensuring adherence to EU cGMP regulations for pharmaceutical products for all manufacturing operations.
To promote a sense of quality throughout the areas of responsibility so as to raise manufacturing / QC performance and eliminate waste caused by unnecessary compliance errors.
To manage and perform audits and follow up actions within the area of responsibility. This will include hosting of external audits and inspections at the manufacturing site and assisting the EU QA Manager in managing responses to any deficiencies observed.
To review non-compliances, deviations and complaints and use technical / professional judgment to make the appropriate product quality decisions and to initiate and promote quality improvements to prevent re-occurrence.
To co-author, review and authorize the content of Annual Product Review reports
To provide technical support for R&D, clinical research and regulatory affairs.
To take the responsibility to release the batch according the product specification file or marketing authorization according to annex 16 of GMP
To support any audit an GMP inspection, corrective and preventive actions follow up
The successful candidate would be required to work in accordance with a shift pattern which can involves night working.
The role is based in Murcia.
The jobholder must hold minimum of 1 year experience in a pharmaceutical company.
The job holder will be eligible under either the permanent arrangements for nomination as a Qualified Person on the site Manufacturers License.
Good written and verbal English communication skills are required.
Degree in Pharmacy.