QC Analytical SME
Position Overview
The QC Analytical SME supports the site's laboratory information management system (LIMS) technology refresh, working closely with the central project team, central developers and the Site Implementation Manager (SIM). The role covers authoring and reviewing validation documents, contributing to method harmonisation, testing and verifying templates before they go live, and embedding new working practices in the analytical laboratory. The role requires strong ownership of workload and timelines, in line with site procedures and regulatory requirements.
Key Responsibilities
- Participate in and support the LIMS technology refresh in accordance with site procedures and regulatory requirements, including writing, reviewing, executing and approving validation-related documentation
- Author, peer review and own requirement documents, and gather and populate data for the central project team so templates can be developed within agreed validation timelines
- Engage in method harmonisation with the central developers and site business process flow
- Provide real-time feedback and identify errors while templates are in development, comparing against existing ways of working (e.g. Sapphire or laboratory worksheets) to minimise rework
- Complete formal verification of final templates to confirm they are fit for use in the analytical laboratory
- Develop and train new, efficient and compliant working practices, creating supporting procedures and training packages
- Deliver local business change initiatives driven by the SIM
- Manage own workload to agreed deadlines, highlighting blockers and proposing solutions to the SIM in a timely manner
- Work with the site instrument maintainer to execute IQ/OQ for all instruments connected to the new LIMS
Required Qualifications
- Degree or diploma in Chemistry, Biological Sciences, Pharmaceutical Science or a related field
- 0-5 years of experience in a QC or analytical laboratory environment
- Working knowledge of LIMS (e.g. Sapphire, gLIMS) and laboratory worksheets/templates
- Familiarity with GMP, GDP and data integrity requirements
- Experience or understanding of validation documentation, including IQ/OQ
- Good communication and training skills, with the ability to work with cross-functional and central project teams
- Able to manage own workload, meet deadlines and flag issues proactively
Why join us?
- Generous Leave Policy.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.