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Work Schedule

Other

Environmental Conditions

Office

Job Description

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 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 EngineeringEngineering or equivalent.

• GMP, Pharma background, manufacturing of sterile products knowledge is preferred

• Strong communication, interpersonal, and problem-solving skills.

• Ability to work effectivelyin a fast-paced and dynamicenvironment

• Outlook Package Knowledge

• Good knowledge of the English language (both written and spoken)

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.