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    Quality Assurance Manager - Berkeley Heights, United States - Breckenridge Pharmaceutical, Inc.

    Breckenridge Pharmaceutical, Inc.
    Breckenridge Pharmaceutical, Inc. Berkeley Heights, United States

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    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, QA/QC Testing /Audit program, and Quality/Compliance 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 compliance
    • Manage 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 Foods
    • Manage product quality complaints
    • Support FDA audits/inspections of the company or its manufacturing partners, as needed
    • Product Quality Reviews, including review of manufacturers' reports of annual product reviews
    • Manage change control review of Dietary Supplements and Medical Foods products
    • Batch record reviews, as required

    ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

    • BS required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)
    • 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
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