This is a permanent full-time position, working a 35-hour week, 7 hours per day flexibly between 7am & 7pm on 5/7 days as per business needs.
The purpose of this job is to perform stability testing of finished pharmaceutical products and produce accurate results within an acceptable timeframe.
Responsibilities:
* Perform routine and non-routine analysis using traditional and modern analytical techniques (primarily: HPLC, Dissolution, and Karl Fisher determination), as required by the client’s representative.
* Perform technology transfers on new products entering the team.
* Review analytical data for GMP compliance.
* Initiate and follow up on OOS results and action limits as per client procedures.
* Document data as dictated by current client policies and procedures.
* Collect and measure productivity through agreed metrics such as number of tests performed, cycle times, lab/product issues, number of hours worked per project, etc.
* Prepare and approve results for tests in which they have received the appropriate training and are deemed competent.
* Deal with client queries and contact designated personnel, with appropriate support from onsite leadership, with any relevant information or issues relating to test results or the service in general.
* Keep up to date with any technological or method revisions in their area, ensuring their training is complete and adjusting their work as required with approval from the Lead Analyst.
* Support local audits as required.
* Perform testing of QC samples in accordance with client procedures.
* Revise SOPs as required.
* Adhere to all client standards in the areas of safety, housekeeping, and quality, notifying management of any discrepancies.
Minimum Requirements:
* A degree in Chemistry or a related discipline is required.
* A sound, fundamental knowledge of Chemistry is essential, with knowledge of Analytical techniques highly desirable.
* A minimum of 1 year relevant experience of analysis in a pharmaceutical testing laboratory (preferably with exposure to solid dose products), or equivalent, is desired.
* The candidate should be experienced and competent with traditional analytical techniques as well as modern instrumental equipment (HPLC, Dissolution, Karl Fischer, and UV spectroscopy).
* Experience in technology transfers desirable but not essential.
* Must be able to interpret raw data and draw conclusions regarding troubleshooting of analyses, instruments, and methods.
* Have a thorough understanding of chromatographic techniques.
* Must possess experience of, or have a thorough understanding of working in a GMP environment.
* Must possess the ability to quickly learn new processes.
* Be capable of working proactively to offer suggestions for new ways to improve existing processes.
* Should have the ability to work using paperless systems such as Electronic laboratory notebooks and LIMS.
* Must be competent with MS Office suite of applications.
* Requires the ability to form strong working relationships with colleagues.
* Must have the ability to work on their own initiative and be capable of developing solutions to problems as part of a team.
* Must be willing to operate in a flexible manner and be able to switch priorities at short notice.
* Should seek new ideas to make improvements within own area of control.
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