Pds Analytical Development & Gmp Scientist Lazio

Pds Analytical Development & Gmp Scientist
Roma
Lazio, Lazio

What will you do?

** - 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 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) **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