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Job Details

Manager, Quality Assurance

Company: RBW Consulting
Location: Bridgewater, NJ
Reference: RA-MQA-BNJ
Closing Date: 10 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

Our client is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. They also offer contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.

Requirements:

Manager, Quality Assurance

Bridgewater, NJ

Our client is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. They also offer contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.

The Quality Assurance Manager is responsible for maintenance of the companies quality management system, batch record review and ensuring that operations are conducted in accordance with current Good Manufacturing Practice.

Responsibilities:

  • Develop, initiate, manage and implement improvements to quality systems and processes
  • Ensure that all operations are compliant with cGMPs regulatory requirements.
  • Write, review and approve SOP system documents to ensure cGMP compliance, as required
  • Review and approve raw materials and components, manufacturing documents, including standard formula, test analyses, batch production records and batch packaging records for release
  • Review and approve quality control documents, including quality specifications and testing standards
  • Oversee the storage of retained samples and batch documentations
  • Develop and report on Quality Metrix
  • Develop and implement vendor / supplier managerial program
  • Conduct qualification audits on vendor / supplier
  • Participate in deviations and OOS result investigations
  • Ensure proper root-cause analysis and implement corrective and preventive actions
  • Planning and implementation of Quality Review Board meetings
  • Interface with all levels of the clients team to resolve issues
  • Support development/projects, as needed
  • Other responsibilities as and when required

Qualifications:  

  • Bachelor (required) /Master degree in Life Science or other related discipline. Minimum of 6 years relevant experience in a pharmaceutical quality assurance/control environment
  • Experience of GMP document review, Quality Management System maintenance, quality auditing
  • Understand the requirements and procedures related to document control and Quality Assurance

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087 today!

Apply for this job: Manager, Quality Assurance

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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