Quality Consultant

ID: 611843
Type: Contract
Location: Dayton, OH
Contact Email: jprovenzano@judge.com
Salary: Open
Our client is currently seeking a Quality Consultant for a 3 month consulting assignment.

This will be a three month engagement to start with immediately. The person will be responsible for the following tasks:

 

•             Develop and monitor GMP compliant quality systems

•             Write, review, revise and approve GMP related documents to include, but not limited to: SOPs (Standard Operating Procedures), protocols, validations, deviation and system documentation

•             Function as Project Manager for various GMP projects. This may include the development and oversight of production plans, resource allocation and generation of time lines. Monitor project progress, ensure timely completion

•             Provide quality guidance and consultation to direct reports and management personnel to ensure that the company is GMP compliant

•             Perform raw materials and product approvals. Review for compliance with GMP applicable requirements, data and reports by QC and external vendors for raw materials used in GMP manufacture and outgoing GMP products

•             Perform batch record review

•             Perform investigations of out of specification (OOS) results and non-conformance

•             Initiate and approve CAPAs (Corrective and Preventive Action documents)

•             Develop and conduct internal GMP training

•             Conduct internal GMP regulatory audits. Make procedural recommendations to ensure compliance

•             Participate in and/or conduct external GMP regulatory audits (e.g. suppliers, contract labs)

•             Lead GMP meeting

 

REQUIREMENTS:

•             Minimum of 10 years of experience with quality systems, GMP regulatory compliance, methods and procedures preferably in a pharmaceutical environment. Five years in a leadership or management role

•             In-depth knowledge of GMP guidelines and regulations, including EMEA and other international GMP requirements for bulk substances and finished drug products; ICH GMPs for API (Active Pharmaceutical Ingredients)

•             Excellent interpersonal, verbal and written communication skills

•             Analytical and problem-solving skills

•             Attention to detail, organizational skills, ability to multitask and follow tasks through to completion

 

Joy Provenzano, VP- Recruiting, The Judge Group

90 Matawan Rd, Suite 102, Matawan, NJ 07747
office (732) 497-4246

Or you can text me at: (484) 585-4189

www.judge.com

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Let’s connect on linkedin: http://www.linkedin.com/in/joyprovenzano

 

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