Environmental Assurance Associate (18 Month Secondment / Fixed Term Contract)
Location: Macclesfield
Introduction to Role
Are you passionate about ensuring the highest standards in manufacturing processes? As an Environmental Assurance Associate, you will provide microbiological QA expertise and support for manufacturing. You will ensure that manufacturing processes and operational controls meet aseptic requirements and conform to the critical control strategy. Overseeing aseptic and clean room operations, you will ensure particle, physical, and microbiological environmental control in production and/or QC testing facilities. Your role directly impacts the value stream by influencing clean room decisions through expert advice, ensuring compliance with current regulations. Accountabilities
Ensure an effective microbiological, particle, and physical monitoring programme is established and maintained. Provide technical advice on clean room standards, aseptic behaviours, and their impact on procedures/manufacture in line with the Critical Control Strategy. Assist in major failure investigations, ensuring recommendations for product disposition are made and documented. Maintain and develop your professional capability. Provide training and coaching to personnel. Act as a key user of EQV; ECMS author, approver, and deviation manager for deviations/environmental excursions. Conduct self-inspections and observations. Perform Environmental reviews to support batch release. Manage change control. Proactively seek opportunities to improve environmental compliance by suggesting improvements to monitoring programmes and procedures. Manage local and cross-functional change. Ensure high aseptic standards are maintained in production and/or QC testing in clean rooms. Participate in regulatory and internal audits and inspections. Contribute to the preparation of regulatory submissions/PQR process. Essential Skills/Experience
Qualified to degree level/or equivalent in one of the sciences or with experience in a GMP environment. Sound knowledge and understanding of the principles of aseptic manufacture and associated GMPs. Essential Functional Capability at the Professional level- Aseptic Manufacture and Environmental Control. Knowledge of Current GMP requirements related to their Technical expertise and of regulatory processes. Knowledge of microbiological and physical environmental monitoring. Desirable Skills/Experience
Experience (or equivalent) in the Environmental Assurance Office role. Good communication and influencing skills including cultural awareness. Understands own leadership styles, capabilities & their impact on the team. There may be a requirement to work shifts in this role as required by the business. Ready to make an impact? Apply now to join our team!
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Are you passionate about ensuring the highest standards in manufacturing processes? As an Environmental Assurance Associate, you will provide microbiological QA expertise and support for manufacturing. You will ensure that manufacturing processes and operational controls meet aseptic requirements and conform to the critical control strategy. Overseeing aseptic and clean room operations, you will ensure particle, physical, and microbiological environmental control in production and/or QC testing facilities. Your role directly impacts the value stream by influencing clean room decisions through expert advice, ensuring compliance with current regulations. Accountabilities
Ensure an effective microbiological, particle, and physical monitoring programme is established and maintained. Provide technical advice on clean room standards, aseptic behaviours, and their impact on procedures/manufacture in line with the Critical Control Strategy. Assist in major failure investigations, ensuring recommendations for product disposition are made and documented. Maintain and develop your professional capability. Provide training and coaching to personnel. Act as a key user of EQV; ECMS author, approver, and deviation manager for deviations/environmental excursions. Conduct self-inspections and observations. Perform Environmental reviews to support batch release. Manage change control. Proactively seek opportunities to improve environmental compliance by suggesting improvements to monitoring programmes and procedures. Manage local and cross-functional change. Ensure high aseptic standards are maintained in production and/or QC testing in clean rooms. Participate in regulatory and internal audits and inspections. Contribute to the preparation of regulatory submissions/PQR process. Essential Skills/Experience
Qualified to degree level/or equivalent in one of the sciences or with experience in a GMP environment. Sound knowledge and understanding of the principles of aseptic manufacture and associated GMPs. Essential Functional Capability at the Professional level- Aseptic Manufacture and Environmental Control. Knowledge of Current GMP requirements related to their Technical expertise and of regulatory processes. Knowledge of microbiological and physical environmental monitoring. Desirable Skills/Experience
Experience (or equivalent) in the Environmental Assurance Office role. Good communication and influencing skills including cultural awareness. Understands own leadership styles, capabilities & their impact on the team. There may be a requirement to work shifts in this role as required by the business. Ready to make an impact? Apply now to join our team!
#J-18808-Ljbffr
