The Olon Group is a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and biological processes while always embracing the highest international safety, quality and environmental standards.
Olon has a global network of 11 production sites and 7 research and development centers around the world.
For the plant in Rodano (MI) and for the plants in the province of Lodi, we are looking for Quality Control Analyst profiles experienced in validation of analytical methods.
The resource will be placed within the Quality Unit and will report to the Laboratory Manager.
Specifically, the resource will be responsible for:
- Writing analytical procedures, protocols, and validation reports in English
- Performing validation activities of analytical methods and processing the data obtained
- Developing analytical cleaning methods
- Familiarizing and/or optimizing analytical methods
- Defining procedures and approaches to analytical validations/transfers of analytical methods related to QC
- Performing analytical testing on IPC, MP, INT, API and cleaning verification
- Accurately documenting the work process and test results in accordance with cGMP requirements
- Requesting materials and equipment needed for work activities and training personnel to maintain them
- Using analytical instrumentation (LC, GC, ICP, XRPD, PSD, cKF, etc.) in accordance with GMP and internal guidelines
- Planning work to ensure proper project steps
- Filing and maintaining appropriate documentation for the laboratory
- Performing laboratory investigations and completing reference forms
- Using glove boxes in case of high containment products
The ideal candidate possesses:
- Diploma and/or Degree in Chemical or Related field
- Knowledge of and compliance with regulations related to Environment, Health and Safety (EHS)
- Basic knowledge of GMP / GDP rules, rules related to Environment Health and Safety (EHS) and proper use of Personal Protective Equipment (PPE)
- Ability to work in full compliance with Data Integrity in order to ensure that data is attributable, understandable, up-to-date, original and accurate (ALCOA+)
- Knowledge of basic laboratory SOPs, knowledge of GC Chromatographic instruments, HPLC, UHPLC
- Good knowledge of Office package
- Willingness to work on deadlines with good energy level, self-motivation and high organizational skills
We offer concrete opportunities for professional growth through structured career paths, state-of-the-art instrumentation and ongoing training within a multinational context.
The remuneration package will be competitive and commensurate with the candidates’ experience.