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 non-conforming 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- Hands-on 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 problem-solving 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 processPLg3bs8vb5