Process Support Unit Lead

Healthcare Businesswomen’s Association; Torre Annunziata; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical company in Torre Annunziata is seeking a Process Support Unit Lead to coordinate and plan all manufacturing activities, ensuring compliance with safety and quality regulations. The ideal candidate will have a scientific or engineering degree, substantial experience in a manufacturing or QA environment, and strong people management skills, with proficiency in Italian and fluency in English.

Competenze

• Previous solid experience within the manufacturing/QA/engineering department of a pharmaceutical company.
• People management skills.
• Proficient in Italian. Fluent in English.

Mansioni

• Lead the process unit team in coordinating and planning all activities with manufacturing responsibility.
• Monitor compliance activities necessary for the release of batches produced.
• Ensure processes remain consistent with good manufacturing practices and apply safety regulations.
• Manage the preparation and execution of internal and external audits and GMP inspections.
• Participate in defining the operational improvement strategy.

Conoscenze

Assembly Language

Change Control

Chemical Engineering

Chemistry

Continual Improvement Process

Efficiency

General HSE Knowledge

Good Documentation Practice

Knowledge Of CAPA

Knowledge Of GMP

Lean Manufacturing

Manufacturing Process

Manufacturing Production

Process Control

Productivity

Risk Management

Root Cause Analysis (RCA)

Scheduler

Six Sigma

SOP (Standard Operating Procedure)

Team Work

Technology Transfer

Web Methods Flow

Formazione

Scientific or Engineering degree

Descrizione del lavoro

Job Description Summary

The Process Support Unit Lead leads the process unit team in coordinating and planning of all activities with end-to-end manufacturing responsibility (logistics, project work, operational excellence, resources and budget/costs) in a way that is consistent with a culture of self-direction (empowerment and
accountability). Ensures full compliance with quality, Health, Safety and Environment (HSE), Good Manufacturing Practices (GMP), customer service, statutory, regulatory and Novartis requirements.

Job Description

Major accountabilities:

• Transmits knowledge, skills and information to members of his team on objectives, problems, performance indicators, values and behavior
• Monitor compliance activities necessary for the release of batches produced in
  compliance with the defined dates.
• Ensure that the processes remain consistent with good manufacturing practices (cGMP) and apply the rules and regulations for safety, health and the environment.
• Ensure the appropriate management of the quality events within the appropriate
  timeframe (escalation, description, investigation of the cause, evaluation of the impact and criticality, etc.).
• Ensure the availability of appropriate operational expertise resources in order to
  maintain the validated state of the manufacturing processes in the unit as well as the qualified and validated state of the equipment in the area.
• Provide necessary support for the preparation and submission of regulatory dossier (in the context of transferring new products or variations of existing products / processes), and in answering questions from health and safety / environment authorities.
• Manage the preparation, execution and follow-up of internal and external audits and GMP and HSE inspections.
• Manage the production documentation flow within the production unit (SOPs; MBRs; Forms etc).
• Ensure overall inspection readiness for area of responsibility.
• Participate to the definition of the operational improvement strategy and the portfolio of continuous improvement projects. Plays a key role in the prioritization of improvement actions based on available resources.

Essential requirements:

• Scientific or Engineering degree.
• Previous solid experience within the manufacturing/QA/engineering department of a pharmaceutical company.
• People management skills.
• Proficient in Italian. Fluent in English.

Skills Desired

• Assembly Language
• Change Control
• Chemical Engineering
• Chemistry
• Continual Improvement Process
• Efficiency
• General HSE Knowledge
• Good Documentation Practice
• Knowledge Of CAPA
• Knowledge Of GMP
• Lean Manufacturing
• Manufacturing Process
• Manufacturing Production
• Process Control
• Productivity
• Risk Management
• Root Cause Analysis (RCA)
• Scheduler
• Six Sigma
• SOP (Standard Operating Procedure)
• Team Work
• Technology Transfer
• Web Methods Flow