SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.
We are seeking a Scientist to join their Deeside team.
Duties and Responsibilities:
To perform physical and analytical stability testing on existing and new medical devices and skin care products according to pre-determined stability study protocols, SOPs, OCIs and TDs in support of product shelf-life and product labelling.
Analysing, documenting, interpreting, and reporting laboratory data for stability studies to GMP/GLP standards.Perform maintenance, calibration, documentation and updating quality records for Stability equipment.Maintain compliance to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.Provide technical knowledge to some stability studies with support from Senior Scientist.Experience with a wide range of analytical equipment such as balances and pipettes through to HPLC and ICP-MS.Performs Lab/OOS investigations with some supervision incorporating problem-solving and troubleshooting for future improvements.Responsible for the ordering of laboratory consumables, chemicals, reagents, and equipment when required.Assist with the drafting of stability documentation such as protocols and reports.Ensure the Stability labs are maintained as a safe working environment, raising near misses where needed.Support planned and ad-hoc stability sample set-downs, pull requests and support laboratory tasks as and when required.Collation of stability data, including physical data retrieval, for stability/technical reports.Assist in the storage and retrieval of stability samples.Liaise with external vendors via telephone and when on site and arrange maintenance, service, and calibration contracts.Support the organisation of new and existing studies including sample retrieval.Support appropriate accelerated and real-time aging programmes that are suitable for the study in concept.Actively generate improvement ideas (Lean/6S) for the Stability laboratories and suite.Identify improvements to current stability processes.Requirements B.Sc. or equivalent in a scientific disciplineLab experience out with university – placement, year in industry or professional role is desiredExperience with LIMS is also desirableCompetent in following and adhering to pre-determined stability study protocols, SOPs, OCIs and TDs.An active team player disciplined in adhering to group objectives including taking an active role in team collaborative activities.Good working knowledge of Microsoft Office - specifically Word and Excel.Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines.#J-18808-Ljbffr