In few words
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Position: Quality Assurance Coordinator
Location: Madrid
Experience: A minimum of 2-3 years' experience in similar positions. Essential minimum 2 years' experience in quality assurance or quality systems in production plants, distribution center and/or affiliates. Experience in cGMPs, cGDPs, Quality for Marketing Affiliate. Quality Assurance and Quality control and/or manufacturing processes. Office system. ISO 13485 for medical devices.
Global Responsibility
Assure compliance of GxP, regulatory and internal standards according to quality policies and applicable requirements within affiliates/subsidiaries. Management of quality documentation (procedures, reports, etc.). Management of quality technical agreements and their fulfilment. Support to affiliates/subsidiaries
Specific Responsibilities
* Ensuring that appropriate Quality systems are established, implemented, and maintained in each market in scope, 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 Quality teams across marketing affiliates/subsidiaries per region in the resolution of serious quality issues and quality management documentation.
* Support Quality training program for Exeltis affiliates/subsidiaries.
* Third Party quality management oversight: Manage technical quality agreements between Third Partiers and Exeltis, establish a good quality management oversight in routine operations, identify risks and propose risk mitigation.
* Develop and monitor Quality metrics related to third party organization and marketing affiliates.
* Collect, prioritize, drive and monitor execution of strategic Quality initiatives in affiliates and subsidiaries.
* Stay current with the applicable regulations and promote Quality across the organization.
* Support Affiliates/Subsidiaries in the implementation of Quality digitalization strategy
Requirements and personal skills
* Education: University Degree in Pharmacy or Medium Diploma in Pharmacy or equivalent. Pharmaceutical Industry Master will be a plus.
* Languages: Fluent in English, Spanish will be a plus.
* Experience (years/area): A minimum of 2-3 years' experience in similar positions. Essential minimum 2 years' experience in quality assurance or quality systems in production plants, distribution center and/or affiliates
* Specific Knowledge: Experience in cGMPs, cGDPs, Quality for Marketing Affiliate. Quality Assurance and Quality control and/or manufacturing processes. Office system. ISO 13485 for medical devices.
* 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. xohynlm We foster a diverse, inclusive, and respectful work environment.