Work Schedule
Other Environmental Conditions
Office 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 PDS 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 3 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;
Personnel training, checking of correct applications of GMP and operating procedures;
Full cooperation in the different phases of the projects implementation and validation;
Ensure that the CAPAs and action from Change Control are i mplement ed 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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