Reporting to the R&D Supervisor, the R&D Senior Analyst is responsible for the Analytical Method development, validation and testing of new products and line extensions for Univet in line with cGLP/cGMP practices with an innovative approach
Key role requirements
- Product development and process validation experience, including introduction of new product to the site and optimisation of existing manufacturing methods.
- Sourcing of external R&D laboratories for development and validation of new analytical test methods.
- Development and validation of analytical methods using various analytical techniques including HPLC, Dissolution and Wet Chemistry in line with current guidelines.
- · Lead and take ownership of the analytical aspects of various in-house and external R&D projects including writing and reviewing related protocols, reports and test methods.
- Managing aspects of stability programmes conducted internally and externally for assigned projects.
- Supporting Regulatory Affairs during the submission of new dossiers and responses to deficiencies from Competent Authorities for new applications and variations of existing licenses.
- Assist when necessary in formulation support activities of in-house newly developed products
- Effective completion of Analytical Method Verifications and technical transfers as requested.
- Ensure equipment is maintained in accordance with cGMP requirements in terms of operation, raw data processing, maintenance, calibration and qualification.
- Collaborate with team members and other department functions to achieve common goals
- Provide training to junior R&D personnel in terms of Analytical method development, verification and validation.
- To Prepare, Review and Check basic and advanced area documentation (Laboratory notebooks, laboratory logbooks, SOPs, change controls and Specification Sheets).
- To ensure that work is carried out in compliance with the organization’s quality system.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve
- Minimum of 4 years’ experience within an analytical development laboratory environment
- BSc Degree in Chemistry or other related discipline
- Strong analytical/quantitative skills
- Previous experience with HPLC and Dissolution
- Thorough understanding of quality systems and cGMPs.
- Proven ability to work independently with minimal supervision
- Self-initiating / self-directed
- Ability to troubleshoot analytical instruments
- Previous experience with Empower software
- Previous experience with UPLC
- Basic understanding of the New Product Development process