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M4468s6fy7k5b81jhb0

Quality Consultant

The Judge Group Dayton Full-Time
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Our client is currently seeking a Quality Consultant with heavy GMP experience in a pharmaceutical company.

We are looking for a senior quality assurance consultant who has good experience in managing quality operations in a GMP environment. 

This is for a manufacturing customer based near Dayton, OH.   Must be on-site in Dayton OH 5 days per week.

•             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 report  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 nonconformance

•             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
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Celebrating 50 Years of Success

 

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Recommended skills

Quality Management
Product Quality Assurance
Attention To Detail
Coordinating
Verbal Communication
Written Communication

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The Judge Group is a privately owned, leading professional services firm with nearly 50 years of experience in providing technology, talent, and learning solutions. Our services are successfully delivered through a network of more than 35 offices in the United States, Canada, and India. The Judge Group serves more than 47 Fortune 100 companies and is responsible for 7,000 professionals on assignment annually across a wide range of industries.

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