**How will you make an impact?**
The pharmaceutical manufacturing plant in Monza is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized, with an increasing focus on biologics.
You will play a crucial role in leading and managing the Master Batch Record team within our dynamic organization. You will be responsible for overseeing the daily operations, fostering a positive work environment, and ensuring that team members are motivated and equipped to achieve their goals. This position requires strong leadership skills, excellent communication abilities, and a proactive approach to problem-solving
**What will you **do?**
- Team Management: Manage a team of (number) employees, including recruitment, training, performance management, and career development. Foster a culture of collaboration, accountability, and continuous improvement.
- Performance Monitoring: Monitor team performance against key performance indicators (KPIs) and targets. Identify areas for improvement and implement strategies to optimize team productivity and efficiency
- Communication: Facilitate open and effective communication within the team and with other departments. Ensure that team members are informed about company policies, procedures, and updates
- SOPs Revision and optimization
- Ensure that Master Batch Records are issued in order to ensure cGMP compliance with EMA and US FDA requirements;
- Full cooperation in the different phases of the projects implementation and validation;
- Ensure that the CAPAs and action from Change Control are implemented in the MBRs;
- Involvement in the technical meeting with the clients for the introduction of the new process/products in our PDS sterile departments and for the revision of MBR instructions directly with client through call or dedicated meeting;
- Active participation in internal audits, client audit/Regulatory inspections;
- Management of the client's requests about production processes;
- Collaboration with the whole QO, Process Scientist, MSAT, Equipment Validation, Supply chain, Production Dept
- Involvement in training courses.
**Knowledge, Skills, **Abilities**
- Degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering Engineering or equivalent.
- GMP, Pharma background, manufacturing of sterile products knowledge is preferred
- Strong communication, interpersonal, and problem-solving skills.
- Ability to work effectively in a fast-paced and dynamic environment
- Outlook Package Knowledge
- Good knowledge of the English language (both written and spoken)
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