Lead QA Technician

No more than 2-3 sentences

What will you do?

Manages Deviations, Investigations relevant to quality issues impacting batches manufactured for clinical and commercial use, by ensuring their completion within the expected timelines;

Manages the CAPAs resulting from quality investigations;

Supports the preparation of periodic quality trends, intended for Management and Corporate visit;

Manages non-conformities in receiving raw materials, active ingredients and GMP materials (incoming defects).

Supports and actively participates in initiatives/projects with Operational Excellence;

Actively participates in all meetings established for new and ongoing projects by taking care quality topics;

Examines and verify and manages Deviations and Investigations with several functions to define the causes and implement the corrective action plan within the timelines established by technical agreements;

Collaborates with DPS (Commercial division) colleagues in organizing technical and management meetings with customers;

Participates in customer visits and quality inspections (Audit);

Generates reports regarding DPS quality events (quarterly monitoring);

Contributes to the achievement of quality objectives for the part under his responsibility, and of the RFT, Deviation Rate, Past due, Ontime closure objectives;

Collaborates with Quality System colleagues in reviewing the SOPs that fall within the scope of the DPS;

Provides customers with TLC and email support by promptly responding to quality questions;

Carries out training of staff involved in quality compliance activities for DPS;

Participates in the drafting of Risk Assessment;

Supports and executes negotiation of Quality Technical Agreements with Customers

Degree in Pharmaceutical Biotechnology/ Pharmacy or Chemistry

3 – 5 years of relevant experience in Quality Assurance/Operations Preferably experience in a Pharmaceutical or Life Science company

Knowledge, Skills, Abilities

English (Speaking and writing fluent) Italian Fluent

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