About us: Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.
Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations.
Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).
COMMITMENT TO EQUAL OPPORTUNITIES Insud Pharma is aware that business management has to be in line with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
Global Responsability Assure compliance of GxP, regulatory and internal standards according to quality policies and applicable requirements within Insud Pharma Group.
Management of quality activities in products commercialized in the countries under HUB scope.
(Complaints, Deviations, PQRs, Recalls, Quality Agreements, etc).
Support to the MAH to compile to the applicable local legislation where the products are marketed.
Specific Responsabilities Reporting to External Manufacturing Quality Manager.
Ensuring that appropriate Quality systems are established, implemented, and maintained in each market in scope of the HUB organization, and appropriate oversight is in place to ensure that local regulatory requirements can be supported in a simple, compliance and continuous improvement manner.
Providing support to MAH in the resolution of serious quality issues and quality management documentation.
Suppliers management: Manage technical quality agreements between Third Partiers and the MAH, establish a good quality management oversight in routine operations, identify risks and propose risk mitigation.
Be the key contact between MAH and the different sites involved in the supply chain of the product (Manufacturers, transport companies, distributors.. etc).
Develop and monitor Quality metrics related to third party organization related to the products under HUB organization.
Stay current with the applicable regulations and promote Quality across the sites.
Support MAH in the implementation of Quality digitalization strategy.
Requirements Education: University Degree in Pharmacy or Medium Diploma in Pharmacy or equivalent.
Pharmaceutical Industry Master will be a plus.
Languages: Fluent in English and Spanish.
Experience (years/area): At least 2 years' experience in quality assurance or quality systems in distribution center/affiliates and/or manufacturing sites.
Specific Knowledge: Experience in cGDPs, cGMPs, Quality for Marketing Affiliate.
Quality Assurance and Quality control and/or manufacturing processes.
Office system Travels: Willing to travel occasionally.
Personal skills: Good communication skills, proactivity, energy, good working under pressure, problems-solving, good organizational skills and persistent.