Pharmaceutical Quality Systems SME

Philadelphia, PA

Job ID: 128702 Industry: Pharma

 

Pharmaceutical Quality Systems SME

Environment:

Our client is a Pharmaceutical company in need of a team of high level consultants to do a deep dive Quality Systems revamp. This client works with contract packaging and manufactures generic drugs, OTCs and Rx drugs.

Job Duties/Responsibilities:

This client recently received a class I recall for mislabeling and has a lack of process in Quality Assurance and Quality Systems. They have several system inadequacies surrounding; Quality Systems procedures, process and controls and organizational structure. These consultants need to have experience working with companies under FDA scrutiny and/or remediation experience.

The consultants will be focusing on three major areas; the organizational structure, roles, responsibilities, decision authority, competency and role of Quality Assurance. The client is currently undergoing personnel changes and is looking for support in helping to staff employees.

QMS and its deployment, inclusive of processes, procedures, documentation, metrics, and reports (both design and execution).

Governance processes and how those interact to support timely corrective actions and continuous improvement in processes/systems necessary to maintain compliance and patient safety, as identified and appropriate.

Required:

Pharmaceuticals

GMP

Quality Systems (design & execution)

Remediation

Desired:

Contract Packaging

Solid Dose

Bilingual in Spanish

 

Job Type: Contract

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