Job DescriptionJob Description
About the Company
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.
About the Role
This position reports to the 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, Medical Foods or Foods for special dietary use.
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
Qualifications
- Bachelor of Science required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)
- Minimum 10 years' experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems (preferably at least 5 years in a QA-management role)
- Ability to travel domestically 3-4 times per year to perform audits on facilities, potential international travel
Required Skills
