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Corporate Quality Assurance Technician 1, Barcelona
Client: ISDIN
Location: Barcelona, Spain
Job Category: Other
EU work permit required: Yes
Job Reference:
918090267438245478432460
Job Views:
1
Posted:
23.07.2025
Expiry Date:
06.09.2025
Job Description:
Mission: Collaborate in the implementation of the Quality Manual in the affiliates and assist in the audit plan for manufacturers, subsidiaries, distributors, licensees, CROs, and logistics operators.
Functions:
* Quality system management: claims, change control, deviations, and CAPAs.
* Review and approval of Corporate Areas documentation: Pharmacovigilance, Clinical, Toxicology, Regulatory, HR, IT, Purchasing, Supply & Operations, Marketing, R&D Laboratory (SOPs, validations, transfers, specifications, analytical methods, change control, manufacturing methods, deviations, CAPAs).
* External audits of GMP services of finished product manufacturers, packaging material, external microbiological and analytical labs, licensees, and distributors; GLP of CROs for safety and efficacy in-vitro studies; GCP of CROs for in vivo and clinical studies; GDP for storage and transport; GVP of CROs for pharmacovigilance services.
* Internal audits to Corporate Areas and subsidiaries.
* Assist in the implementation of the Quality System of subsidiaries (review of procedures).
* Writing/Reviewing Quality Agreements.
* Review of manufacturing documentation and batch control of subcontracted manufacturers for market release.
Functions Cont.- Computerized Systems Validation
Requirements
* Education: University degree in Pharmacy, Biology, Chemistry, Engineering, or Health Sciences.
* Experience: At least 5 years in Production or Quality of active ingredients or pharmaceutical products, in development or industrial scale. GMPs domain.
* Languages: Proficiency in English and Spanish (read, spoken, written).
* IT: Office programs.
Desirable:
* Training in Quality Systems. Knowledge in ISO 9001, ISO 13485 (Medical Device), ISO 22716 (Cosmetics). Knowledge in GDPs, GLPs, GCPs, GVP.
* Experience in audits. Experience in cosmetics, food supplements, pesticides, microbiology, injectables, and medical devices. Experience in corporate/international Quality organizations.
* Languages: Other languages (e.g., French, German, Italian, Portuguese, Chinese).
* IT: ERP (e.g., SAP), Documental Systems (e.g., Documentum, Qumas), Quality Systems (e.g., Trackwise).
* Others: Decision-making capability, autonomy, team working, attention to detail.
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