Associate Director

Role & responsibilities-

• Reviews statistical data and analyses manufacturing data to identify areas of opportunity for implementing solutions that enhance quality and compliance.
• In-depth knowledge of guidelines on drug substance and sterile injectable products and quality management systems.
• Improves and optimises process, material, and people flows in bottleneck environments. Conducts time studies and methods analysis where needed to identify opportunities for improvement and facilitate standard work.
• Recommends methods for improving the utilisation of personnel, material, and machine capability. Develops and deploys value stream mapping to help stakeholders understand the value versus waste analysis.
• Collaborates with cross-functional teams, including production, quality, supply chain, and site leadership, to ensure the sustainability of best practices and solutions.
• Handles regulatory inspections and prepares audit compliance reports.
• Responsible for assessing, reviewing, and tracking vendor service agreements.
• Ensures quality and compliance wherever GMP activities are performed within the department and at the site.
• Must have core competency in dealing with manufacturing QMS, including investigation, CAPA, and change control
• Tracks and trends CAPA for the site and verifies its effectiveness.
• Reviews, coaches, and guides investigation execution, preparing timelines for QMS activities and ensuring timely closure
• Manages the documentation cell.
• Handles queries from regulatory agencies.
• Develop comprehensive technical training content covering all aspects of pharmaceutical utility operations and engineering and maintenance. This includes creating presentations, guides, manuals, and other training materials in various formats

Preferred candidate profile

Around 17-20 years of experience and a BE in Mechanical or Instrumentation. In-depth knowledge of the latest guidelines and hands-on experience in qualifying various production equipment, including vial, cartridge, and pre-filled syringe (PFS) filling machines, washing machines, depyrogenation tunnels, sealing machines, isolators, autoclaves, terminal sterilizers, and lyophilizers. The candidate will also be responsible for Engineering store, QMS & driving training programs.

Interested candidates can share their resumes to this email ID- Pavan.BBILPVTR6084@biocon.com