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Director of Quality in Cranbury Township, NJ at Synerfac

Date Posted: 4/10/2019

Job Snapshot

Job Description

Title: Director of Quality
Location: Cranbury, NJ

Position Function:

This position is responsible for overall management of all aspects of quality. It includes management of Quality Control and Quality Assurance functions. Develop policy requirements, provide leadership and forward planning to both departments.

Responsibilities

This person will work in the Quality Department and oversee the direction and management of Quality Assurance and Quality Control departments. This person will interact with regulatory agencies and customers as needed. Interaction with other departments and support manufacturing operations for GMP batch manufacture and QC laboratory analytical testing as required.

Principal duties and responsibilities include:

• Development of Quality framework to support commercial and clinical supplies of pharmaceutical products.
• Management of Quality Assurance and Quality Control Units within the company.
• Support all cGMP activities occurring at the facility.
• Facilities regulatory and customer audits.
• Oversees setting and enforcement of training requirements.
• Insure appropriate staffing requirements within Quality departments.
• Review & give guidance on issues to resolve problems and maintain effective control within the facility.

  Job Requirements  

TECHNICAL KNOWLEDGE

• Knowledge of GMP regulations, Parts 210, 211 of the Federal Register, ICH Guidelines and practices.
• An understanding of pharmaceutical manufacturing requirements including facilities, systems and equipment is required.
• Understanding of laboratory operation for Quality Control and analytical work including basic knowledge of methods and analytical instruments such as HPLC, GC, TOC, UV, FTIR, Dissolution, Karl Fisher moisture determination, pH, conductivity is required.

QUALIFICATIONS:

• Education: BS/MS in a Pharmaceutical, Biological, Chemical science or related field
• Experience: 10 years experience in a Pharmaceutical QA Managerial/Supervisory position.
• Knowledge/Skills: Working knowledge of computers, Word, Excel, Outlook, PowerPoint.
• Communications, oral, written, negotiations and interpersonal skills.