Senior Aspetic Specialist
Posted 17 days 11 hours ago by Careerwise Recruitment
A Senior Aseptic Specialist is required by CareerWise Recruitment for a permanent position with our Louth based pharmaceutical client. If you are a specialist Isolator Glove Management & End to End Media Fill (Process Simulation) then this is the position for you.
Responsibilities- Leadership for the Environmental (including EMPQ) & Media Simulation Programs within the manufacturing area.
- Develop & deploy the Aseptic qualification process within the department.
- Oversee coordination of compliance enhancement projects within the clean room areas.
- Lead the End-to-End Media Fill (Process Simulation) program including strategy alignment, competency build, execution and GMP Audit defence.
- Develop & grow the Isolator Glove Management Program at site.
- Contribute to cleanroom operation and contamination control procedures in operations IPT including cleaning and sanitization, garbing, people & material flow, and segregation procedures.
- Ensure compliance with MSD Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP) in day-to-day activities and all applicable job functions.
- Provide SME insight to aseptic queries during deviations or audit activities.
- Serve as manufacturing IPT lead in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines.
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or related technical discipline.
- 3-5 years' operations experience in a Drug Product and sterile manufacturing environment.
- Previous experience with Media Simulations required (either executing within or coaching teams through).
- Sterile filling processes (Grade A Isolator) and equipment knowledge required.
- Prior experience with GMP Audits required.
Please call Louise Mulligan today for further information on or email:
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy.