Chemistry Operations Specialist Lazio

Chemistry Operations Specialist
Roma
Lazio, Lazio

How will you make an impact?

The Chemistry Operations Specialist is a joining link between Analysts and Team Leader/Supervisor, working with clients and managing the laboratory 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, semi-finished and finished products (Release and Stability)

- 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 Team Leader / 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 Team Leader / Supervisor to identify the requirements for analytical technology transfer from customers, then ensuring the correct and effective transfer to the laboratories

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

**Education**:

Degree in CTF, Chemistry, Biology or other similar fields

Diploma Chemical/Laboratory technician certificate

**Experience**:

- Multi-year experience in Quality Control

- Experience in pharmaceutical industries

**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