Direct Hire

Our client, an international distributor of pharmaceutical ingredients, seeks a Quality Assurance Manager on direct hire basis.  This is a high visible position reporting to the COO.

Detailed Duties & Responsibilities:

* Ensure the organization meets all the applicable guidelines and regulation established by FDA, Dietary Supplements, cGMP and ICH.

* Perform quality management practices including Total Quality Management (TQM), and continuous quality management to monitor all processes.

* Lead investigations of quality related product complaints.

* Executing validation protocols for products, process and facilities to assure quality attributes for the company.

* Prepare, complete and authenticate documents with FDA for enquiries related to USDMFs.

* Supporting corporate and other branches of the group on QA&RA.

* Review and approve operational records, planned deviations, change requests and product releases.

* Reporting Management as required on trends, Quality issues, Deviations, Complains, SOP implementations, Releases, CAPA program, or any other QA&RA related KPIs.

* Responsible for document control and compliance.

* Responsible for all, external and internal audits for compliance to 21CFR Part 111.

 

Requirements:

* Bachelor's Degree in Chemistry 
* ASQ Certification is a plus
* Familiar with FDA, cGMP, and ICH are a plus

* Experience in management of a Quality Team.

Competitive salary + bonus