Senior Aseptic Processing Specialist

6 days ago


Baddi, Himachal Pradesh, India beBeeSterility Full time ₹ 18,36,375 - ₹ 23,85,050

As a Microbiology Operations Leader, you will play a critical role in ensuring the site's sterility assurance programs align with global and regulatory standards.

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Key Responsibilities:

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  • Develop and implement contamination control strategies and management plans to ensure continuous improvements in sterility and aseptic manufacturing.">
  • Oversee and manage the site's Sterility Assurance program, serving as the primary subject matter expert for all sterility assurance and microbiology-related matters during regulatory inspections and client audits.">
  • Lead and guide all aspects of aseptic processing, including environmental monitoring, media fills, smoke studies, and critical batch operations.">
  • Manage and mentor the Sterility Assurance team, providing clear direction, performance feedback, and professional development opportunities.">
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Requirements:

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  • Master's degree in Microbiology, Biology, or a related scientific field.">
  • Minimum of 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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