Band

Level 2

Job Description Summary

-Shift Lead I -The Shift Leader is responsible for managing his team to carry out the manufacturing operations according to schedule in compliance with HSE and GMP rules. -Process Specialist / Equipment Specialist -Execute assigned manufacturing tasks and activities according to production schedule to enable the timely production of product with the quality and quantity in compliance with the relevant GMP, safety and environmental guidelines. -Documentation Specialist GMP -The Documentation Specialist GMP reviews and consolidate the Batch records after production in order to deliver them to Quality Assurance acc. to set timelines And in right quality. The Documentation Specialist GMP performs entries and verifies transactions/declarations in the ERP system.

Job Description

Major accountabilities:

Shift Lead I

Represent production management to the team members and promote Novartis values within the team
Line responsibility and shift walkthrough
Engage and motivate the team and delivers strong results with an empowered team

Process Specialist

Participation to the manufacturing processes
Perform all Equipment Operator Tasks/Responsibilities
Shift supervision, team coordination planning And support where shift-lead does not exist or when shift lead is absent
Perform operators on-boarding, training and training status follow-up

Equipment Specialist

Participation to the manufacturing processes
Perform all Equipment Operator Tasks/Responsibilities -Suggest improvement actions (organization, process, safety, hygiene, etc.) at shop floor

Documentation Specialist GMP

Prepare, print and consolidate the batch documents, labels and handover to production operators within the deadlines set according to the production schedule
Follow up on updates and versions of documents in production (procedures and logbooks)
Manage the documents review and approval cycle
Complete the ERP (SAP) and RFT (right first time) databases, make available and participate in the analysis of trends and performance indicators
HSE and Quality -Promote and improve the Safety and Quality cultures
Ensure overall inspection readiness for area of responsibility
Participate in HSE risk assessments
KPI and Data Reporting for process teams
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Distribution of marketing samples (where applicable)

Key performance indicators:

Achieve plant KPIs
Human Resources Performance: Satisfaction survey, execution of Talents and development plans, technical training program in place and executed, training data, attracting and retaining talent, succession plan for Manufacturing team in place and robust.
Deadlines: compliance with production planning, execution of tasks on time.

Minimum Requirements:
Work Experience:

Operations Management and Execution

Skills:

General HSE Knowledge
GMP Knowledge

Languages:

English.

Skills Desired

General Hse Knowledge , gmp knowledge

Tehnik v proizvodnji farmacevtskih učinkovin (m/ž/d)