Corporate Quality Assurance Technician 1
hace 3 meses
Mission
Collaborate in the implementation of the Quality Manual in the affiliates and collaborate 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 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.
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.
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**: English and Spanish proficiency read, spoken and written.
IT: Office programs.
Requirements Cont.
DESIRED
**Education**: Training in Quality Systems. Knowledge in ISO 9001, ISO13485 (Medical Device), ISO22716 (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, orientation to detail
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