Job Description:
At Team Horizon, we are seeking a highly skilled Senior Microbiologist to join our client based in Sligo. This individual will be responsible for providing an effective microbiological and analytical service to the sterile biologics facility, ensuring that Microbiological procedures and requirements are met.
Why this opportunity is unique:
* Join a world-class manufacturing operation with a proven track record of delivering high-quality medicines to patients worldwide suffering from serious illnesses.
* Be part of a culture that continuously strives for improvement and innovation, aiming to improve health outcomes and dramatically impact people's lives.
* Contribute to the development of our client's capability to produce all its medicines, ensuring continuity of supply as they expand internationally.
Key Responsibilities:
* Implement the facility's sterility assurance program and microbiological support activities (facility design, filling of sterile product, and aseptic practices).
* Lead and implement microbiological and analytical services to meet and maintain all requirements for aseptic processing, facility design, and filling of sterile product.
* Oversee the EM and utilities program process, aseptic programme, and contamination control strategy in a multiproduct facility.
* Provide microbiological/sterility assurance/technical governance of in-process and finish product per product requirements.
* Understand regulations and business processes required to maintain Abbvie's and cGMP requirements for sterile product, inclusive of facility design, cross-contamination controls, microbiological laboratory standards, and data integrity.
* Define and update procedures for site relative to microbiological and environmental monitoring. Interface with regulatory and corporate inspectors/auditors.
* Carry out training as per training plan to support facility sterility assurance program.
* Adhere to and support all EHS & E standards, procedures, and policies.
EHS Responsibilities:
* 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.
* Attend all required EHS training and medical surveillance programs.
Requirements:
* Bachelor Degree qualification in biology or microbiology.
* A 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, and working in a sterile/aseptic/pharma environment is a distinct advantage.
* Experience in supporting regulatory inspections HPRA, FDA, etc., is an advantage.
* Experience in cleaning validation is an advantage.