A Senior Aseptic Specialist is required by CareerWise Recruitment for a permanent position with our Louth based pharmaceutical client. Do you want to part of the first ever live Vaccine site in Ireland and If you are a specialist Isolator Glove Management & End to End Media Fill (Process Simulation) then this is the position for you!!!!
THE ROLE:
- Leadership for the Environmental (inc 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.
- Effectively 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.
- Responsible for contributing to the cleanroom operation and contamination control procedures in operations IPT including but not limited to: Cleaning and Sanitization, Garbing, people & material flow, and segregation procedures.
- Required to comply with MSD Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Ability to contribute 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.
REQUIREMENTS:
- 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 0949003979 or email: lmulligan@careerwise.ie
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, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.