Qc Packaging & Raw Materials Team Leader Lazio

Qc Packaging & Raw Materials Team Leader
Roma
Lazio, Lazio

Ensure supervisory and effective/efficient planning of analytical activities of utilities and starting materials (Packaging materials, Excipients and API / DS), through the planning and control of the progress of daily activities, in order to meet OTD/RFT (on time delivery / right first time) of the manufacturing plan and client requests.

The QC Packaging & Raw Material Team Leader works with the Manufacturing Planning team to make raw materials available for manufacturing activities

**What will you do?

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- Ensures both the execution and constant supervision of analytical laboratory activities for projects assigned in accordance with GMP requirements, supporting analysts in problems solving for analytical activities relating to API / DS, Excipients, Packaging Materials, materials GMP, utilities

- Draws up analytical specifications, study protocols and reports, analytical methods and SOPs in compliance with current regulations (current EU GMP, US GMP) and company quality standards.

- Coordinates with the Supervisor the customer's management with the aim of maintaining a high level of customer satisfaction and completing the required activities on schedule

- Participates in calls/meetings with customers to support the discussion on technical topics for their area of expertise

- Collaborates with the Supervisor to identify the requirements for analytical technology transfer from customers, then ensuring the correct and effective transfer to the laboratories

- Collaborates with the Supervisor in managing laboratory investigations (Out of Specification and Deviation Reports)

**How will you get here?

- Degree in CTF, Chemistry, Biology or other similar fields Diploma Chemical/Laboratory technician certificate

- Experience in pharmaceutical industries

- Multi-year experience in Quality Control

**Knowledge, Skills, Abilities

- Knowledge of the main techniques of chemical-physical and biochemical analysis and validation of analytical methods

- Knowledge of GMP and national/international regulations

- Good problem-solving abilities

- Proficiency in Microsoft Office suite and both analytical and statistical software (Empower, MiniTab, Sample Manager)

- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment