Environmental Assurance Officer
Location: Cheshire East
Job Type: Full time
Environmental Assurance Officer
Opening date 13/01/23
12 month secondment or FTC (fixed term contract)
Join an environment of excellence, where we’re backed by a belief that good can always be better. It means we search for opportunities to add value – harnessing science and evidence to foresee risk. A place to continuously innovate to find new and better ways to ensure we are improving outcomes for patients!
This role is to provide microbiological expertise and support for manufacturing.
To coordinate aseptic and clean room operations with respect to particle, physical and microbiological environmental control in production and/or QC testing facilities. This role will impact directly on the value stream by influencing clean room decisions through advice to others, ensuring the physical and environmental monitoring programme is maintained in compliance with current regulations.
- To ensure an effective microbiological, particle and physical monitoring programme is established and maintained.
- To provide technical advice with respect to clean room standards and advice on clean room discipline, good aseptic practice, associated cGMPs, and their impact on procedures/manufacture.
- Deviation management. To assist in major failure investigations ensuring recommendations for product disposition are made and documented.
- Maintain and develop own professional capability.
- To provide training and coaching of personnel.
- Perform MSDM documentation updates.
- Self-inspections and observations.
- Batch review
- OCM Change control management
- To ensure an effective aseptic gowning and Operator Media Trial programme is established and maintained
Safety, Health and Environment
Promoting an environment of no hurt, harm or alarm
- Work in a manner which promotes the safety and well being of self, others and environment
- Contribute to improving SHE performance, proactively use STOP cards to identify SHE hazards and take appropriate actions
GMP / Compliance and Ethical Conduct
Ensuring compliance of self and others to internal and external regulations
- Comply with all systems, processes and procedures in line with statutory/ legislative / quality requirements
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
- The individual should be qualified to degree level/or equivalent in one of the sciences or with working experience in a GMP environment.
- The individual should have 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.
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development!
If you are already imagining yourself joining our team, great!
We welcome your application no later than 27/01/22
Competitive salary and benefits.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.