Sterility Assurance Lead

Team Horizon
IE - Leinster - Dublin
November 1, 2024
Medical

Team Horizon is seeking an experienced Sterility Assurance Lead to join our clients team at their manufacturing facility in the Connaught region. This is a permanent position

Why you should apply:
• Excellent opportunity to join an established & growing company as an integral & key member of the team where you will lead & manage projects
• Competitive Salary & Benefits package on offer

What you will be doing:
• Lead and manage the project to upgrade certain cleanroom environments from Grade D to Grade A classification & Develop and implement a detailed action plan, including timelines, resource allocation, cost, and risk management strategies.
• Ensure all microbiological practices comply with GMP and Department of Agriculture, Food and the Marine requirements, and any other relevant regulations.
• Conduct regular audits and inspections to maintain high standard of cleanliness and sterility and bioburden control.
• Design and implement robust environmental monitoring programs for the upgraded cleanrooms & Analyze environmental monitoring data, identify trends, and take corrective actions as necessary.
• Lead aseptic process simulation (APS's) qualification activities as per the guidance of Annex 1 for new and existing equipment that is required to support aseptic processing in the upgraded cleanrooms.
• Develop and execute aseptic process simulation validation protocols and generate comprehensive aseptic process simulation validation reports.
• Experience with validation and qualification of manufacturing equipment, HVAC systems, and other critical systems in a GMP environment.
• Draft, review, and update SOPs related to microbiological practices, cleanroom operations, and environmental monitoring.
• Provide training on microbiological techniques, environmental monitoring, and GMP requirements & Train staff on new and updated SOPs to ensure consistent adherence.
• Coordinating on site aseptic processing and gowning training and implement routine requalification program.
• Implement and maintain effective contamination control strategies to prevent microbial contamination in the manufacturing process.
• Investigate and resolve microbiological deviations and non-conformities.
• Collaborate with Operations, Quality, Engineering and TSA to ensure microbiological quality throughout the manufacturing process.
• Ability to identify potential environmental, health, and safety hazards in the microbiological lab and manufacturing environments.
• Conduct thorough risk assessments to evaluate and mitigate risks associated with microbiological and cleanroom activities.
• Partner with EHS to ensure proper use and maintenance of PPE to protect employees from microbiological and chemical hazards.

What you need to apply:
• Bachelor's degree in Microbiology, Biotechnology or equivalent
• In-depth knowledge of GMP regulations and guidelines. Specific knowledge of aseptic process simulations, cleanroom qualifications and deep understanding of Annex 1 guidance.
• Expertise in microbiological testing, environmental monitoring and contamination control.
• Excellent project management and organisational skills.
• Strong leadership skills - this role requires leading a multidisciplinary team to achieve Grade A classification.
• Excellent problem solving, analytical and decision-making abilities, particularly to trouble shoot and address microbiological deviations and non-conformities.
• Strategic thinker with proven ability for forward planning.
• Strong communication and interpersonal skills. Flexible and agile in support of site's overall mission.
• Minimum of 5 years' experience in a similar role, ideally in a biopharmaceutical manufacturing facility
• experience with cleanroom validation and qualification processes.
• Experience managing and coordinating site environmental monitoring programs

Read the full job description and apply online on the recuiter's web-site

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