Quality Control Lead - Pharmaceuticals

• Approves analyses of raw materials, packaging materials, intermediate products, finished products and stabilities.
• Guarantees the operation of the laboratory, including its economic and training aspects, ensuring that the staff of the department receives initial and continuous training adequate to the needs.
• Organises, performs and ensures the analysis activity to obtain the conformity opinion of the batch, within the established time of the production programme.
• Supervises the management of the correct investigation of out-of-specification and/or trend analyses.
• Drafts and/or approves specifications, sampling instructions, methods of analysis, and other Quality Control procedures, ensuring that they are respected and ensuring continuous revision.
• Ensures the maintenance of the sampling library, standards, equipment and analytical records.
• Ensures compliance with the Stability Programmes established for the products.
• Proposes any improvement in analytical techniques, ensuring that the necessary validations are carried out.
• Participation in external and internal audits.
• Ensures that the Quality processes in the laboratory are implemented and maintained.
• Promotes and participates in continuous improvement processes in the Quality Control laboratory.

• Degree in Pharmacy or similar, with proven experience in the Pharmaceutical Industry in the area of Quality Control.
• Knowledge of Good Manufacturing Practice (GMPs), Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices and FDA 21 CFR".

Michael Page