Documentation Specialist

**Summary**:This Role provides oversight of all GMP documents ( SOPs, FRMS, WPS) and ensures that all documents are updated, trained and effective in alignment with the department needs**About the Role**:**Major accountabilities**:- Revise existing or create new SOPs in time to support Manufacturing Strategy.- Ensure periodic review is completed on time- Coordinate updates with cross functional teams for CAPAs, QEs, Health Authority inspections- Ensure proper training compliance of all associates in- Develop appropriate Individual training plans in collaboration with team leads- Stay current regarding industry standards and ensure that all SOPs are cutting edge and incorporate all latest regulatory and quality requirements- Support Quality Manual implementation through support of gap assessments and implementation of relevant content into SOPs and daily operation.**Key performance indicators**:- MBR right first timeReduction of batch record cycle timeReduction of operational errors98% training compliance of all associatesNo critical audit findings pertinent to SOPs/MBRs**Work Experience**:- 3-5 or more years of related experience in cGMP/FDA regulated industry.- Pharmaceutical GMP's - strong knowledge of Good Manufacturing Practices and regulatory knowledge is a requirement.- Knowledgeable in ESOPs; LMS (Learning Management Systems),- TrackWise; MES knowledge is a plus**Skills**:- Assembly Language.- Cooperation.- Efficiency.- Electronic Components.- Flexibility.- General Hse Knowledge.- Good Documentation Practice.- Installations (Computer Programs).- Iso (International Organization For Standardization).- Job Description.- Knowledge Of Gmp.- Lean Manufacturing.- Manufacturing (Production).- Manufacturing Process.- Nuclear Medicine.- Physics.- Product Distribution.- Production Line.- Scheduler.**Languages**:- English.DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaTechnical OperationsJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Creado: Jue, 01 de Ene de 1970