Aseptic Lead (Sterility Assurance)
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Aseptic Lead (Sterility Assurance)Apply Now
The brief demands a commitment to the efficient control and operation of the sterile core area. They are responsible for ensuring that all manufacturing activities are completed as per approved Standard Operating Procedures (SOP’s), Protocols and Batch Records in a safe manner and in compliance with current Good Manufacturing Practices (cGMP).
- Compliance with Takeda Ireland Ltd (TIL) standards including cGMP (current Good manufacturing Practice).
- Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
- Work and foster good working relationship with cross functional teams
- Perform day-to-day manufacturing and cleaning activities to meet schedules while maintaining a high level of GMP compliance.
- Lead Best practice Aseptic Technique principles current with the GXP/ GMP guidelines
- Attend Seminars on Aseptic technique principles ensuring compliance to current GMP guidelines.
- To aid with troubleshooting and resolving operational problems during processing.
- Ensure all Documentation is completed to the required standard and within the specified timelines.
- Review batch records, Protocols and other manufacturing process records as required.
- Routinely draft and revise standard operating procedures and master batch records.
- To aid in deviation investigations and closures.
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
- Maintain a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business. Support Regulatory licensure activities, including agency inspections.
- Report to Team Lead on a regular basis on line performance and report any issues that need to be resolved.
- To train and be cross functional across all manufacturing areas of the drug product facility.
- To arrange regular 1:1 meetings with the Area Supervisor where Performance and Development plans can be agreed, set and monitored.
- To perform any other task or duties as assigned by Area Supervisor.
- Foster compliance and schedule adherence to ensure the operational plan is achieved, including close out of all documentation.
- Drive a continuous improvement mind-set in line with the Takeda operational excellence program at TILGC.
- Maximize the success rate for production operations by instituting programs to minimize failures. Support Operations plans for plant improvements in order to increase efficiency and drive down costs.
- Communicate operational status regularly to plant management at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
- Maximize the success rate for production operations by instituting programs to minimize failures.
- Other duties as required and directed by the Director, Supply Chain or other Officer appointed by the Board of Directors.
- Science , Engineering or Biochemistry degree or other relevant field of expertise
- At least 5 years experience in aseptic manufacturing environment in the pharmaceutical/biopharmaceutical industry, preferably with experience in the leadership of teams. Experience of aseptic GMP manufacturing and filling is preferred.
• Manufacturing experience in biopharmaceutical operations involving cell cultures or Regenerative Medicines and Vaporized Hydrogen Peroxide decontamination an advantage.
• Experience in operational excellence Lean/Six Sigma, Green Belt Certification is an advantage
• Excellent planning, scheduling and prioritization ability
• Excellent documentation skills and attention to detail.
• Ability to work under pressure & managing conflicting tasks at the same time.
• Experience in electronic quality management and document systems (EQMS, EDMS), manufacturing execution systems (MES) and SAP an advantage.
LocationsGrange Castle, Ireland
Time TypeFull time
Job ID R0022768