to: Follows and observes all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility..., Syniti), Minitab and Word. Demonstrates familiarity with FDA, BSI, ISO and GMP requirements. Personal Attributes: Leads...
members. - Ensure adherence to GMP and safety procedures. - Review and approval of validation documentation...
all safety, GMP, and company procedures and participate in ongoing technical training and development. Assist maintenance...
audits. Manage business strategies regarding product distribution, testing and release. Oversee GMP suppliers and Gilead... ´s Mexico Warehouse Quality System to ensure GMP and GDP compliance. Manage Quality Systems indicators: CAPA, Change Control...
, JPAL, 21 CFR 820, GMP and manufacture of medical devices. - Train the trainers - Preferably three years supervisor...
in corrective action plans. **Responsibilities**: - Ensures compliance with Good Manufacturing Practices (GMP) and Standard...
. Ability to provide step-by-step technical help, both written and verbal. Good Manufacturing Practice (GMP...
/LICENSES and** **AFFILIATIONS** - Bilingual: English/ Spanish preferred - GMP/ ISO knowledge preferred - Excellent...
principles a plus - Experience in a medical device environment with knowledge of ISO , GMP, and FDA regulations. - Must be able...
´s adherence to the established Quality System and GMP/ISO standards. · Assist in completion of risk management and risk analysis.../data analysis and report writing experience. · Experience working on FDA, GMP, and ISO 13485 Regulated environments...