Development & Validation Analysts (Chem)
The main purpose of the role is to develop protocols and procedures for testing purposes, which will include the development and validation of analytical test methods in an efficient and effective manner, in full compliance with relevant documented procedures and pertinent regulatory and quality standards and in line with company requirements.
Roles and Responsibilities:
·To plan and prioritise own day to day workload in line with client requirements and adapt this where necessary in line with client needs and expectations.
·To assist in preparation of technical documentation within the Department, as required.
·To assist in training of others, as required.
·To ensure that all work carried out complies with departmental procedures and is cGMP compliant.
·To ensure that all personal lead times are complied with, subject to the absence of attenuating circumstances.
·To assist in the performance of project work within the team, as required.
·To assist in the development and validation of laboratory procedures within the team, as required.
·To review analytical and laboratory data within the team for accuracy, completeness and compliance with documented procedures.Qualifications, Skills and Experience:Essential·Degree in Chemistry or a related science equivalent (minimum 2:2)·Experience in using complex analytical techniques (HPLC, Dissolution, Karl Fischer)·Previous experience in developing test methods and validating test methods for pharmaceutical dosage forms.·Previous experience of working in a laboratory within a cGMP environment.·Excellent written and verbal communication skills.·Excellent planning and organisational skills.Desirable·Experienced in working with new products.·Strong awareness of international pharma regulations (ICH, MHRA, FDA)·Excellent problem solving skills (including the use of recognised tools and techniques).·Previous experience of supporting and closing out change controls and deviations.·Previous involvement Continuous Improvement activities.If you are interested in this role or are looking for a new position within the Life Sciences Sector then please contact Justyn Withey at justlifesciences dot com
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