QA Batch Release Supervisor

Om jobbet

The Batch Release Supervisor will work as a Quality analyst within the batch release area, coordinating activities related to batch review and release. In addition to the review and disposition of batch records, this position will represent the area in routine batch release meetings and work with functional areas to set priorities for batch release personnel, ensuring adherence to schedule and materials are released in a timely manner. The Quality Analyst will be the Subject Matter Expert (SME) for the batch release process and be able to provide support and or guidance within the department and throughout the company. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and material is readily available.

Responsibilities:

  • Manage direct reports – Lead and coach team under direction of the Quality Compliance Manager, driving a high-performance organizational culture.
  • Participate in routine batch release meetings and activities to prioritize batches requiring review for quality batch release department based on supply needs.
  • Monitor and report status of batches to key stakeholders, acting as a primary point of contact for questions regarding status and priorities for the batch release department.
  • Ensures deviations are initiated for any batch record review related events.
  • Effectively resolve documentation discrepancies and issues with operations and quality personnel in a timely manner to allow for material release
  • Participate in cross-functional teams to improve review efficiency and support
  • Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards.
  • Track monthly Batch Record related KPI’s and develop slides for the Site Monthly Dashboard.
  • Review and approve manufacturing and analytical deviations, out of specification investigations and material non-conformances. Compile data, prepare and review trends. Identify areas of concern and communicate to management.
  • Provide periodic updates at Manufacturing Team meetings to review current batch record errors to improve performance.
  • Train new manufacturing associates on batch record review
  • Review and approve master and production batch records.
  • Review and approve change control documents as it relates to batch records or the batch review process.
  • Review and approve standard operating procedures as it relates to batch records or the batch review process.
  • Maintain inspection ready procedures and participate in internal and customer audits and inspections.

Din profil

Skills/Qualifications:

  • BS/BA degree in Biology, Chemistry, Biotechnology, or related field or an equivalent combination of education and experience in a scientific or health-related field.
  • Minimum 2 years directly related experience supporting compliance in a quality/compliance function/applicable compliance field.

Vi tilbyder

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.