Senior Aseptic Manufacturing Manager

2 days ago

Baddi, Himachal Pradesh, India beBeeSterility Full time ₹ 20,00,000 - ₹ 25,00,000
Job Overview

As a seasoned sterility assurance professional, you will lead the site's sterility assurance program to ensure strict adherence to internal, global, and regulatory standards.

The ideal candidate will possess a strong background in microbiology, biology, or a related scientific field, with at least 10-15 years of proven experience in a cGMP-regulated industry. They will have held a leadership or managerial role focused on sterility assurance for at least 2-3 years.

Responsibilities:
  • Strategic Leadership and Compliance: Oversee and manage the site's Sterility Assurance program to ensure compliance with GMP, ISO, and FDA guidelines.
  • Serve as the site's primary subject matter expert (SME) for all sterility assurance and microbiology-related matters during regulatory inspections and client audits.
  • Develop and implement contamination control strategies and management plans to ensure continuous improvements in sterility and aseptic manufacturing.
  • Lead and guide all aspects of aseptic processing, including environmental monitoring, media fills, smoke studies, and critical batch operations.
  • Team and Process Management: Manage and mentor the Sterility Assurance team, providing clear direction, performance feedback, and professional development opportunities.
  • Oversee the review and approval of critical documentation, including batch records, media fill/Aseptic Process Simulation (APS) protocols and reports, and validation documents.
  • Lead and participate in all key investigations related to sterility assurance, adverse environmental trends, and product non-conformances, performing root cause analysis and implementing effective corrective and preventive actions (CAPAs).
  • Risk Management and Improvement: Drive continuous improvement initiatives by analyzing data and trends from environmental monitoring, media fills, and other critical processes.
  • Provide expert guidance on the microbiological and sterility aspects of change control and new product introductions, ensuring all changes are assessed for potential impact on product quality.
  • Stay current with the latest industry regulations, technologies, and best practices in sterility assurance and microbiology to ensure the site's programs are always at the forefront of the industry.
  • Collaboration and Communication: Act as a liaison between the Sterility Assurance department and other cross-functional teams, including production, quality control, engineering, and quality assurance.
  • Provide expert microbiological and sterility assurance expertise for all cGMP documents.
  • Communicate critical issues to senior management and other stakeholders, providing recommendations and action plans to resolve potential risks.
Requirements:
  • A Master's degree in Microbiology, Biology, or a related scientific field.
  • At least 10-15 years of proven experience in a cGMP-regulated industry, with at least 2-3 years in a leadership or managerial role focused on sterility assurance.
  • Expert knowledge of aseptic processing, cleanroom operations, environmental monitoring, and contamination control.
  • Extensive experience with regulatory inspections (e.g., USFDA, EMA) and a deep understanding of cGMP, ISO, and other relevant regulatory guidelines.
  • Strong leadership, project management, and problem-solving skills, with a focus on root cause analysis.
  • Excellent technical writing, verbal communication, and interpersonal skills.
  • Proven ability to lead, mentor, and develop a team of professionals.

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