Analytical Development & Gmp Documentation Monza

Analytical Development & Gmp Documentation
Monza
Lombardia, Monza

PURPOSE OF THE POSITION / RESPONSIBILITY:

- Perform, with the support of the PDS Supervisor, the compliance of the Quality Control Department with current regulations (laws, European and international GMP standards, etc.

), from a regulatory, corporate policy, Data Integrity point of view, customer needs and requests for adjustment to GMP.

SPECIFIC TASKS / PRIMARY ACTIVITIES:

QUALITY PLAN

- Carry out the development of a quality plan for Quality Control, through the analysis of the gaps, the definition, in collaboration with the functions involved, and the planning of corrective actions, the coordination and supervision of the actions taken, in order to to ensure compliance of the Quality Control with current regulations (laws, European and international GMP standards, etc.

)

PROCEDURES

- Perform the continuous updating of the procedures concerning the area of competence in the drafting and updating of the same, in compliance with current regulations (current EU GMP, US GMP)

INVESTIGATIONS, OOS and DEPARTMENT DEVIATIONS

- Perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to them Collaborating with Supervisor and Team Leader to manage these

DATA INTEGRITY

- Execute and ensure, together with the PDS Supervisor, the integrity of the data issued by the Quality Control, the organization and scheduling of the activities of the assigned personnel and the direction, coordination and control of the sector / activity / group assigned, in compliance with GMP, the methods defined, the company quality standards and the requirements for effectiveness and efficiency of the laboratory.

AUDIT

- Perform and support the Supervisor in carrying out internal audits in the QC, by customers, to and from suppliers, and Regulatory Bodies in compliance with company procedures and quality standards.

REQUIREMENTS AND QUALIFICATIONS:

Studies / Diploma / Training courses:

- Degree in Chemistry, Pharmacy, Pharmaceutical Chemistry and Technology, Biology or proven track record

Technical knowledge:

- Toxicology, microbiology, chemistry

- Main QC analysis techniques

- GMP and national / international regulations

- Office suite

- Track Wise System

Professional experiences:

- Experience in pharmaceutical industries

- Some years of experience in the QC or QA function