- Experience Level
- Experienced (non-manager)
International Pharmaceutical Manufacturer seeks an experienced Stability Analyst on a part time basis, 3 days per week 9 am till 5 pm.
About the role:
To contribute to the Quality Laboratory function, through competently taking and testing samples in accordance with departmental Standard Operating Procedures, Policies, and to the principles of GMP.
Duties may include:
- Set up stability trials, collect and distribute Stability samples.
- Update Stability spreadsheets and records.
- Ship samples to outside testing laboratories (OTLs) and coordinate receipt of results back.
- Perform a variety of testing in accordance with Standard Operating Procedures, policies and GMP.
- Provide practical and administrative assistance to the laboratories testing stability samples.
- Be responsible for preparing reagents, standards and control samples and contribute to general laboratory housekeeping duties.
- Promptly report deviations, out-of-specification / limits results. Assist where required with investigations.
- Read, collate, report and archive results using defined documentation and computer systems.
- Ensure equipment used is clean, calibrated and maintained. Perform system suitability checks where required.
- Assist with the calibration or validation of laboratory equipment and automated systems.
- Operate a variety of instrumentation and computer software packages intended for data analysis, collation and other related applications (e.g. LIMS).
- Participate in the receipt of audits from internal and external sources, ensuring own work area is audit ready at all times.
- Adhere to record and data integrity requirements.
- Perform any other aspects of laboratory testing and support the objectives of the department as required.
Skills and experience:
- Degree in a relevant scientific discipline
- Experience of working in a laboratory environment.
- Understanding of GMP/GLP.
- Good knowledge of the pharmaceutical industry, both within a laboratory and across pharmaceutical processes.
- Knowledge of laboratory SOPs and ability to revise and write new procedures.
- Understanding and knowledge of laboratory operations and practical work.
- Knowledge of stock control and budgeting in own area
- Experience in using analytical equipment and pipettes.
- Experience in writing reports