I have an exciting opening for a ASL Stability/Validation Supervisor with a pharmaceutical company based in Wicklow. Reporting to the ASL Manager, the Stability/Validation Supervisor will be responsible for control of all Reports & Protocols, adherence to site plans, scheduling/release of all associated batches and control of Group Performance. Leading a Team & working in collaboration with other groups and departments, they will ensure that batches are tested in a timely manner to meet all related targets and deadlines.
Responsibilities:
- Oversee the Stability Program ensuring samples are entered/removed from Stability Cabinets and tested/approved within target windows.
- Oversee all Laboratory validation related activities relating to Process Validation, Analytical Method Validation and Cleaning Validation.
- Ensure adherence to Validation Site Master plan.
- Ensure all Validation/Stability protocols & reports are available in a timely manner to meet in-house and regulatory due dates.
- Process all Validation/Stability Regulatory requests.
- Process all DRF’s, LIR’s, OOS’s, CC’s etc in a timely manner so as to meet site targets.
- Attend all regulatory and customer audits as group representative, ensuring that the Group is audit ready at all times.
- Manage & control training within the Group.
- Schedule & Host all Group ‘Piloting’ meetings to facilitate performance and ensure all KPI targets are achieved. Carry out Daily capacity planning based on a standard work approach.
- Process all TMS and HR.net related activity for the Group.
- Continuously develop the Group as a Team and optimize resources in order to achieve targets.
- Responsible for Annual Yearly Development reviews for the Group (YDR).
- Review and update all relevant documentation as necessary, eg SOP’s, Methods/Specifications etc.
- Attend Meetings with other departments (Planning, QA Validation etc) to assist in efficient planning to achieve site validation master plan & stability requirements.
- Act as SME for Stability/Validation during Audit Visits, Laboratory Tours etc.
Requirements:
- Degree in Chemistry/Analytical Science/ Pharmaceutical Science or Forensic Science.
- Strong IT skills.
- Strong attention to detail.
- Demonstrate strong use of initiative/self-motivation and a disciplined approach.
- Good communication skills.
- Strong positive attitude is essential for this position.
