Corporate QA Technician
hace 7 días
From Solutia we are hiring a CorporateQuality Assurance Technician for an important laboratory, leaders in sun care and experts in skincare. Headquarter is located in Barcelona.
Mission:
Ensure GXP compliance with Corporate activities. Collaborate in the implementation of the Quality Manual in the affiliates. Collaborate in the audit plan for manufacturers, subsidiaries, distributors, licensees, CROs and logistics operators.
Key Responsibilities:
- Quality system management: claims, change control, deviations and CAPA
- External audits of GMPs (Good Manufacturing Practices) services of finished product manufacturers, packaging material, external microbiological and analytical labs, licensees and distributors, GLP (Good Laboratory Practices) of CROs for safety and efficacy in-vitro studies, GCP (Good Clinical Practices) of CROs for in vivo and clinical studies, GDP (Good Distribution Practices) for storage and transport and GVP (Good Pharmacovigilance Practices) of CROs for pharmacovigilance services.
- 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 ...)
- Internal Audits to Corporate Areas and subsidiaries.
- Collaborate in the implementation of the Quality System of the subsidiaries (review of procedures)
- Writing/Reviewing Quality Agreements.
- Review of manufacturing documentation and batch control of subcontracted manufacturers for release to the market.
Requirements:
- University degree in Pharmacy, Biology, Chemistry, Engineering or Health Sciences
- At least 5 years in Production or Quality of active ingredients or pharmaceutical products, in development or industrial scale.
- Essential requirement - Audit experience
- GMPs domain.
- IT - Office programs, SAP
- Training in Quality Systems. Knowledge in ISO 9001, ISO13485 (Medical Device), ISO22716 (Cosmetics). Knowledge in GDPs, GLPs, GCPs, GVP.
- English and Spanish proficiency read, spoken and written is a must
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