- Sustaining the global quality control program, sample, test and release raw materials, intermediates and finished products, in order to support the business requirements.
- To support the finished products stability programme.
- Experience of working in a GMP environment.
- Quantitative and qualitative analysis of active pharmaceutical ingredients (APIs).
- Analysis of raw materials and starting materials received by the warehouse; analysis of intermediates from internal production.
- Analysis and management of chemical-physical standards.
- Compilation of the certificate of analysis.
- Preparation of sample for consignment.
- Contacts with external laboratories for product analysis and release.
- Management of department documentation.
- Analysis and management of stability studies.
- Study and execution of analytical methods.
- Preparation and analysis of various reagents.
- Management of non-conforming analytical results. Carrying out the resulting investigation.
- Relationships with analytical equipment suppliers in order to solve any emerging issues.
- Execution of analytical method transfer.
- Recording of analytical results.
- Management of solid / liquid laboratory waste.
- Execution of internal periodic calibration of the instruments according to procedures currently in force.
Experience and knowledge requirements:
- Degree in a scientific discipline (with strong chemistry content).
- 3 years of relevant and proven professional experience gained within a similar position(s), at a similar level.
- Knowledge of the English language. Italian will be considered an asset.
- Highly skilled in the use of principal analytical techniques (HPLC, GC, IR, UV).
- Analytical and problem-solving ability.
- Good IT skills e.g. Microsoft Office (Word, Excel).
- Ability to remain focused in stressful situations, by remaining composed and by taking practical and effective action when this proves necessary, despite shifting priorities, work load, and external pressures.
Sterling Chemical Malta Limited – KMP-52561