Job Description:

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group's own R&D facilities and through strategic partnerships with manufactures from around the world.This position reports to the Associate Vice President, Quality Assurance and will manage or support: cGMP compliance assessment of contract manufacturers, the company SOP and Training systems, QAQC Testing Audit program, and QualityCompliance decisions related to the Company's ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements and Medical Foods. DUTIES AND RESPONSIBILITIES: Perform, support and evaluate third party audits of current and proposed vendors for cGMP complianceManage the SOP system, including writing revising and maintaining SOPs, SOP Tracking and SOP Training Support market distribution of batches Manage the review and resolve batch deviations Out-of-Specification (OOS) reports and proposed Corrective and Preventative Actions (CAPAs) from manufacturers for Dietary Supplements and Medical FoodsManage product quality complaints Support FDA auditsinspections of the company or its manufacturing partners, as neededProduct Quality Reviews, including review of manufacturers' reports of annual product reviewsManage change control review of Dietary Supplements and Medical Foods productsBatch record reviews, as required ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCEBS required (preferably technical science-biology, chemistry, pharmacy or other suitable sciencetechnology)Minimum 7 years' experience in the pharmaceutical industry with focus in Quality Assurance Quality Systems (preferably at least 2 years in a QA-management role)Ability to travel domestically to contract manufacturing sites, chance of international travel for audits