Aseptic Quality Assurance Lead

5 days ago

nalagarh, India beBeeAsepticQuality Full time

Job Title:Aseptic Quality Assurance LeadAre you a seasoned professional with expertise in sterility assurance and quality compliance? Do you have what it takes to drive excellence in our manufacturing processes? We are seeking an Aseptic Quality Assurance Lead to join our team.About the Role:This is a key leadership position that requires the ability to coordinate and implement comprehensive quality management systems, ensuring adherence to regulatory requirements and industry standards. As an Aseptic Quality Assurance Lead, you will be responsible for overseeing and managing various aspects of quality control, including sterilization process validation, microbial monitoring, and personnel training.Responsibilities:Sterile Quality Management: Conduct regular reviews of our sterile quality management practices to identify areas for improvement and implement changes as necessary.Validation/Protocol Studies: Review and evaluate validation studies and protocol changes that impact product sterility, ensuring compliance with regulatory requirements.Media Fill Programs: Oversee media fill programs to ensure their effectiveness in detecting contamination and implementing corrective actions.Microbial Trend Analysis: Analyze microbial trend data to identify potential issues and implement proactive measures to prevent contamination.Environmental Monitoring: Ensure that our environmental monitoring program is robust and effective in detecting contamination sources.Laboratory Testing: Ensure that laboratory testing meets established guidelines and pharmacopeia requirements.Aseptic Interventions: Coordinate and oversee aseptic interventions, gowning qualifications, and contamination control strategies.Requirements:Education: Bachelor's degree in a relevant field (e.g., microbiology, biology, chemistry).Experience: Minimum 5 years of experience in a related role, preferably in a pharmaceutical or biotechnology company.Skills: Strong knowledge of sterility assurance principles, quality control methodologies, and regulatory requirements. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.Benefits:We offer a competitive salary, comprehensive benefits package, and opportunities for career growth and development. If you are a motivated and experienced professional looking for a challenging role, please submit your application.Keywords: Aseptic Quality Assurance Lead, Sterile Quality Compliance, Quality Control, Regulatory Requirements, Microbiology, Laboratory Testing, Environmental Monitoring, Contamination Control.

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