The candidate will support the team leader and his/her team colleagues ensuring the validation of FDA-approved sterile production processes and cleaning activities. S/he will be responsible for writing protocols, executing validation activities and writing validation reports, in compliance with cGMP, Clients’ needs and the Company's quality standards.
The Process & Cleaning Validation Specialist will be directly involved in Technology Transfer projects as a subject matter expert and will closely interact with our international clients.
We are looking for a highly motivated, result-driven professional, who is willing to take up an all-round role in an international environment and will actively contribute to the success of critical projects for the Monza Site.
- Ensure the correct validation and cleaning project process, through the coordination and supervision of activities in compliance with protocols and procedures.
- Be responsible for the technical documentation analysis in order to obtain information that will help him/her to write protocols and validation reports and execute validation activities in compliance with company procedures, Clients’ needs and cGMP.
- Analyze generated data from validation activities and other internal functions, support the other internal function such as the Batch Record and Investigation Team during the handling of any deviations in accordance with protocols and business procedures.
- Manage deadlines, change control activities and corporate procedures related to the whole production process, systems, products.
- Ensure and work for the correct execution of external audits through the provision of necessary information and documentation.
- Knowledge of pharmaceutical process validation and main analytical methods
- Knowledge of GMP, pharmaceutical legislation and national and international guidelines
- Fluent English (written and spoken)
- At least 3 years of previous experience in similar role