Roles and Responsibilities

• Provide support to the GMP/GDP Team Cluster Lead in addressing and coordinating local activities and requirements, as needed.
• Develop functions established in the current legislation to the Marketing Authorization Holder, in the field of the storage and distribution of medicinal products, according to the good distribution practices, to ensure their implementation and compliance.
• Ensure the implementation of good manufacturing practices to third parties under contract.
• Authorize the placing on the market of medicinal products after documentation review.
• Be responsible for the technical documentation concerning laboratory authorization and quality issues.
• Signature of technical documents (technical agreements, declarations and documents related to quality issues).
• Contact person with Health Authorities concerning inspection and control of medicines and/or quality matters.
• Assure the implementation, maintenance and follow up of the Quality management system GDP (change controls, risk management, subcontracted activities, quality indicators, quality system review).
• Be responsible for the compliance and implementation of the GDPs across the company.
• Training on GDP to company employees.
• Management of related to GMP/GDP local nonconformities, quality incidences and CAPA ́s
• Elaboration of GDPs: technical documentation, documents management and archive (concerning quality manual, laboratory authorization, procedures, reports of support, certificates of analysis, certificates of conformity, delivery documentation, technical agreements, contract of services and quality issues).
• Management of returns, destruction of expired products. And deciding on the final disposition of returned, rejected, recalled or falsified products.
• Planification and coordination of GDP Self inspections and quality audits.
• Compile and management of pharmaceutical legislation related to Quality and Pharmaceutical Distribution.
• Collaboration with Supply Chain department in matters related to Quality.
• Contact person with third parties related to quality matters (warehouse subcontracted, distributors, Hospitals, Pharmacies..)

Further Responsibilities

• Support to other company departments at local and Global level. ( i.e. : product launch and advice..).
• Maintain constant contact with Regulatory functions in DSES/DSE and Quality functions in DSE.
• Ensuring relevant customer Quality complaints are dealt with timely and effectively.
• Approving subcontracted activities which may impact on GDP.
• Coordinating and promptly performing any recall operations for medicinal products in DSES.
• Ensuring GDP/GMP suppliers/ service providers/ subcontractors and customers are approved and qualified on regular basis.
• Ensuring public service obligations are met. (GDP)
• Represent DS in internal and external interactions on Quality topics and liaise with functional groups at the Spanish Affiliate, multidisciplinary project and working teams, license partners, authorities, and industry associations related to Quality matters. Build up strong relationship with internal and external stakeholders at the Spanish affiliate and EU head office on Quality matters.
• Participate in SIG Committee meetings and fulfil the responsibilities of ISO Certifications, on GDP Quality matters.

Education & Experience

Education:

• University Degree. An official university degree in Pharmacy (Licenciado en Farmacia) or a Bachelor’s degree in Pharmacy. Required
• A Master’s degree in the Pharmaceutical Industry or equivalent. Preferred

Experience:

• 5 -10 years experience and competencies in the implementation and application of the Quality management system according to GDPs. Required
• Experience on GMPs and Quality system valuable. Preferred

Skills and additional Requirements

• Fulfill with the necessary requirements to the role of Responsible Person in a MAH (Marketing Authorization Holder). High
• Knowledge and trained on GDP. High
• Native Spanish language and high level of English language (written and oral). High
• High level of MS-Office.