Descripción de la oferta
In few words
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Position: Quality Assurance Technician
Location: Madrid
Experience : A t 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. SAP .
Global Responsibility
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 different countries under Exeltis MAs. (Complaints, Deviations, PQRs, Recalls, Quality Agreements, etc). Support to the MAH to compile to the applicable local legislation where the products are marketed.
Specific Responsibilities
Reporting to Exeltis Manufacturing Quality Manager.
Ensuring that appropriate Quality systems are established, implemented, and maintained in each market, 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.
Stay current with the applicable regulations and promote Quality across the sites.
Support MAH in the implementation of Quality digitalization strategy.
Requirements and personal skill
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.
Our benefits!
Permanent contract
Flexible schedule
Health insurance coverage
Professional development opportunities
Selection process
Initial contact through phone or email.
1-2 interviews conducted virtually or in person.
Continuous communication about the selection status.
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COMMITMENT TO EQUAL OPPORTUNITY
INSUD PHARMA promotes gender equality and does not discriminate based on ethnicity, religion, sexual orientation, disability, or any other condition. xiphteb We foster a diverse, inclusive, and respectful work environment.
