Develop, implement, supervise, and sustain the systems required to assure the release of products that will satisfy our customers' requirements.
- Oversees day to day operational QA batch release activities for sterile products manufactured at the facility.
- Supervises daily activities of Batch Record Reviewers to ensure timely review and release of batch documentation for the products while ensuring compliance with cGMPâ€™s and SOPâ€™s.
- Uses judgment skills and interacts with various departments from QA Documentation Control group, planning, QC labs, Manufacturing, to identify, trouble shoot and rectify any issues related to batch release.
- Supervises, trains, mentors and provides guidance for Batch Record Reviewers and Production Batch Record Reviewers.
- Dispositions all finished products manufactured on site.
- Creates, drafts, updates and modifies procedures related to operational Quality batch release and other activities. Review, provide comments and approve functional area procedures.
- Responsible for oversight of batch record reviews and releases while working closely with Supply chain to meet Shipment priorities.
- Leads Project teams to enhance, improve and streamline batch records cycle time.
- Oversees non-conformances and CAPAâ€™s related to QA activities and review/approval of facility non-conformances in Track-Wise, including OOSâ€™s.
- Facilitates on the Shop Floor QA Program (Real Time Batch Record Review).
- Works closely with QA functional teams to align and promote awareness on data integrity and good documentation practices.
- Facilitates Hold notification forms and Shipment Under Quarantine forms on Finished Products while pending QA disposition.
- Reviews QC and Environmental Monitoring data to ensure compliance to specifications prior to batch release.
- Report of weekly/monthly/quarterly metrics (Right the First time, Cycle Time, Error free and Success Rate) to Quality Management.
- Review, approve and initiate change requests in order to align with master batch record updates.
- Act as a liaison to external parties relating to the quality system and product release.
- Consistently interpret and apply corporate policies, procedures, FDA, ICH, and other regulatory guides/guidelines.
- Will interact with all functional departments within the company including hourly, professional and management personnel.
- Bachelorâ€™s degree (BS) is required
- Minimum of 2 years related lead/supervisory experience in the pharmaceutical industry with extensive knowledge of quality management techniques, sterile products, and quality systems.
- Must be detail oriented.
- Must have accomplished skills in computer-assisted documentation systems.
- Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
- Must have a team work attitude
- Ability to follow safety and security practices
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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