QA Contractor/Consultant Experienced

Description

Position Title: Quality Assurance Contractor/Consultant - Experienced
Reports to: Director, Regulatory Affairs
Department: Quality Assurance

General Summary:
Responsible for managing existing quality systems and implementing new systems, as needed to support all GCP, GLP and GMP operations. The ideal candidate will have experience with quality oversight of GCP, GLP and GMP functions involved in drug development. Position is a part-time contract position but could eventually become a full time permanent position.

Principal Duties and Responsibilities:
* Conducting gap analysis of existing quality systems;
* suggesting and implementing new procedures/processes to improve/expand existing quality systems;
* writing; revising and maintaining company SOPs;
* ensuring compliance with internal SOPs and applicable drug development regulations;
* overseeing internal and external audit programs;
* conducting GCP audits of vendors and sites;
* overseeing vendor qualification program;
* supporting software and hardware validation,
* maintaining QA documents, records, logs;
* reviewing batch records;
* overseeing out of specification investigations and CAPA;
* maintaining quality agreements with vendor/contractors and
* overseeing training program and maintaining employee training records.

Requirements

Qualifications:
Education
* Minimum: bachelor's degree in a science (e.g., biology, chemistry, pharmaceutical sciences)

Experience/Skills
* At least 5 years of experience managing the GxP (GLP, GMP, GCP) quality aspects of drug products in development
* Good organizational, verbal, analytical, and problem-solving skills. Self-driven, confident and dependable.

To find out more about Real Staffing please visit www.realstaffing.com