Qms/ Gmp Consultant - Los Alamos (Colmenarejo), España - MMS

MMS

Empresa verificada

Los Alamos (Colmenarejo), España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

This role is a project-based consulting opportunity.

Responsibilities:

Establish or maintain record management for a GMP facility
Computer Software Validations/ eQMS implementation:
Experience implementing eQMS systems
Create computer validation plans
Assist in testing of systems
Create procedures for users, maintenance, and security of systems
Establish or maintain GMP/ QMS training for a GMP facility
Create controlled documents for compliance with a quality system
Batch record review and/or release, including ensuring process controls are met for a production run, reviewing all documents related to the lot, and working with client to address any items found prior to release of the lot
Assist in the qualification of suppliers for use for a GMP facility including preparing Evaluation questionnaire, Quality Agreements, and supplier tracking, as needed.
Experience with interacting with regulatory authorities during a Health Authority Inspections
Experience with performing investigation, Correction plans, and preparing response to regulatory authority observations.
Experience with performing error investigations of procedural errors, customer complaints, or nonconforming material.
Experience creating CAPA plans and performing risk assessments
Experience planning, executing, and reporting of method, process, or equipment validations

Requirements:

10 years of experience in a GMP/ QMS role within the CRO, Pharma, or Biotech industry
Bachelors Degree in a scientific, medical or clinical discipline
Expert knowledge of scientific principles and concepts
Handson experience with clinical trial and pharmaceutical development preferred
Good communication skills and willingness to work with others to clearly understand needs and solve problems
Excellent problemsolving skills
Good organizational and communication skills
Familiarity with current ISO 9001 and ISO 27001 standards preferred
Familiarity with 21 CFR Part 11, FDA, and GCP requirements
Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process

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