Labeling and Packaging Operations Specialist

A global pharma company in Rehovot is searching for a Specialist to join our Supply Chain team.

Primary responsibility of the position would be to ensure that all printed packaging materials meet the requirements of Good Manufacturing Practices (GMP) and comply with all regulations related to labeling of prescription drugs.

Responsibilities:

·        Part of the Supply Chain team, reporting to the Global Supply Chain Manager , with dotted line responsibility to the Global VP of Regulatory Affairs

·        Act as a subject matter expert for packaging and labelling

·        Responsible for the compliance of labeling content with regulatory requirements in applicable territories

·        Working with subject matter experts in Supply Chain, Regulatory, Marketing, Quality and Manufacturing, responsible for management of full life-cycle of packaging materials

o  Collection and summary of design requirements

o  Management of regulatory submissions related to labeling

o  Management of print vendors

o  Post-approval change management

o  Basic graphic design work in Adobe Illustrator

·        Review and approve records related to deviations and investigations, change control and CAPAs.

·        Working with internal interfaces, mainly the marketing, RA, QA and QP, as well as with external suppliers.

·        Perform inspections and evaluation of the required suppliers.

·        Liaising with external consultants and internal team, provide regulatory support for supply chain activities.

·        Secondary packaging materials Vendor Management

Requirements:

·        Practical Engineer/ Academic degree in relevant disciplines

·        At least 2 years’ experience in GMP environment

·        Relevant Knowledge in regulatory requirements and guidelines in the pharma industry / Previous experience in RA

·        Professional writing skills (regulatory and quality documents)

·        Graphic design software experience would be considered a strong asset

·        Very good written and verbal communication skills in Hebrew and English

·        Self-learner with strong inter-personal skills, team player, able to work with multiple interfaces, including global ones.

·        Full time job in Rehovot (Hybrid as needed)

·        Willingness to work in flexible hours due to different global time zones, as needed.