We are currently looking for an Aseptic Trainer to join our team in AbbVie Ballytivnan, Sligo.
This person will be responsible for defining and updating procedures for the site in relation to gowning, aseptic behaviours and contamination control strategy.
This person will be an SME in sterility assurance, microbiological, environmental monitoring and contamination control topics and has the opportunity to have a positive impact on our growing site in Sligo.
ResponsibilitiesImplement an effective and robust training and requalification program for isolator activities, Grade C and Grade D gowning and aseptic behaviours on site.Provide governance and support for sanitisation programs on site.Support the facilities sterility assurance program and microbiological support activities to ensure the facility design, equipment and filling process meet aseptic requirements from design to end user.Represent AbbVie Ballytivnan in aseptic governance for projects to ensure all requirements for aseptic processing, facility design and filling of sterile product are met as per regulatory and global requirements.Support the EM and utilities program process, aseptic programme and contamination control strategy in a multiproduct facility.Understand regulations and business processes required to maintain AbbVie's and cGMP requirements for sterile product, inclusive of facility design, cross contamination controls and data integrity.Define and update procedures for site relative to gowning, aseptic behaviours and contamination control strategy.Carry out training as per training plan to support facility sterility assurance program.Adhere to and support all EHS & E standards, procedures and policies.Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.Report any EHS incidents and/or near misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve.Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve.Wear PPE as required.QualificationsA thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.3-5 years' (minimum) experience in microbiology is a requirement & working in a sterile/aseptic/pharma environment is a distinct advantage.Experience in supporting regulatory inspections (HPRA, FDA, etc.)
is an advantage.Bachelor Degree qualification in biology or microbiology.
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