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 process
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