Description
Global pharmaceutical company is seeking a QC Stability Supervisor.Main Objectives:
To manage the Stability Group to ensure the site stability program supports the release to market of safe and high quality products for the duration of their shelf-life.
To develop the Stability Group into an efficient and high performing unit.
Main Duties:
-To supervise and develop the entire Stability team (both laboratory testing and stability coordination teams)
-To participate in internal audits, corporate audits and Health Authority Inspections as the Stability subject matter expert in explaining and defending the stability program on site
-To identify opportunities for optimisation of the stability program on site.
-To coordinate the stability program on site to ensure there are no gaps in the stability program, ensuring that all products where required are placed on -Stability and tested as per ICH and cGMPs.
-To ensure all documentation (stability protocols, reports, test methods, etc) is prepared and approved as per SOPs and as per cGMPs, EU and FDA guidelines
-To manage the stability testing program to provide optimum use of resources and efficient analysis ensuring all test and reporting schedules are met. To manage relationships with external testing sites.
-To ensure CAPAs arising from LIRs , investigations, change controls, internal audits & Health Authority Inspections are implemented as per agreed timelines.
-To develop and manage appropriate training systems for all personnel, to provide skilled and fully cross-trained staff within the team.
-To implement and maintain the 5-S standard of housekeeping in the lab in support of high levels of housekeeping and hygiene.
-To adhere to all company and legislative health, safety and environmental requirements.
-To provide support functionality to the QA function and to perform any other duties as assigned by the QC Manager.
Requirements:
-Minimum 3 years experience of coordinating an overall Pharmaceutical Stability Program.
-Previous experience in team supervision.
-A good working knowledge of Pharmaceutical Pack types, manufacturing processes and analytical processes for Oral solid dosage forms.
-An in depth knowledge of ICH, EU and FDA guidelines on Stability and Analytical testing.
-Third level qualification in a science related discipline.
-Excellent communication skills and the ability to interact effectively with all stakeholders.
-A knowledge of Minitab and/or statistical packages.
-If you are interested in this great opportunity and have the relevant skill set and experience please contact me Anna Mooney or apply below with an up to date CV
If you are interested in the role please contact me Anna Mooney or apply with an up to date CV.