Operations Manager - Label and Packaging

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13594682

## Who We Are

Fagron is the global market leader in pharmaceutical medicine, and its

products are sold to more than 200,000 customers in over 60 countries.

The goal of Fagron is: Together we create the future of the personalized

medicine. Fagron, together with prescribers, pharmacists, and customers,

strives to improve medications and help the patient. From our position

as market leader, we act locally and think internationally.

## About the Job

[The Label and Packaging Manager is responsible for overseeing all

labeling and packaging activities for sterile drug products in

compliance with FDA 503B regulations, cGMP standards, internal quality

systems and production schedules. This includes managing manual and

automated labeling processes, training personnel, maintaining

documentation, continuous improvement intiatives and ensuring product

integrity prior to release.]{contrast="none"}

**[Key Responsibilities]{contrast="none"}**

• [Lead, develop, and manage the label and packaging teams, ensuring
  
  

adherence to SOPs and cGMP standards.]{contrast="auto"}

• [Oversee the accurate label and packaging of sterile injectable
  
  

products.]{contrast="auto"}

• [Collaborate with Quality and Production to investigate label and
  
  

packaging-related deviations and non-conformances.]{contrast="auto"}

• [Ensure compliance with FDA 503B requirements and industry best
  
  

practices for sterile product inspection.]{contrast="auto"}

• [Support investigations related to labeling discrepancies, mix-ups,
  
  

deviations, and packaging

events]{contrast="auto"}[.]{contrast="auto"}

• [Manage and trend defect data to identify recurring issues and
  
  

implement corrective actions.]{contrast="auto"}

• [Participate in internal and regulatory audits as the subject matter
  
  

expert (SME) for labeling and packaging.]{contrast="auto"}

• [Support the qualification, validation, and maintenance of automated
  
  

labeling systems.]{contrast="auto"}

• [Maintain compliance with GDP (Good Documentation Practices)
  
  

requirements.]{contrast="auto"}

• [Review and trend packaging errors, deviations, and documentation
  
  

issues.]{contrast="auto"}

• [Implement corrective and preventive actions (CAPAs) related to
  
  

packaging operations.]{contrast="auto"}

## Basic Qualifications

• [Bachelors degree in life sciences, engineering business or
  
  

regulatory preferred]{contrast="auto"}

• [3 years of experience working in a regulated
  
  

environment]{contrast="auto"}

• [2 years of leadership or supervisory experience
  
  

preferred]{contrast="auto"}

• [Excellent attention to detail and documentation
  
  

skills.]{contrast="auto"}

• [Strong analytical, organizational, and communication
  
  

abilities.]{contrast="auto"}

• [Familiarity with quality management systems, deviation/CAPA
  
  

systems, and audit processes.]{contrast="auto"}

• [Ability to work cross-functionally in a fast-paced regulated
  
  

environment.]{contrast="auto"}

• [Ability to work with others in a positive and professional manner
  
  

and to develop and maintain strong working relationships with

co-workers and management.]{contrast="none"}

• [Ability to take initiative, including asking for and offering help
  
  

when needed; performs work independently without being

prompted.]{contrast="none"}

• [Strong attention to detail and focus on quality, accuracy, and
  
  

accountability.]{contrast="none"}

• [Promote a culture of quality, compliance, teamwork, and continuous
  
  

improvement.]{contrast="none"}

• [Support employee engagement and retention
  
  

initiatives.]{contrast="none"}

## What\'s on Offer?

We offer a dynamic environment where talent and ambition can develop to

its fullest. We have an open and informal organization culture, where

ndividuals need to have strong motivation and ability to work

independently. Fagron is a widely expanding, international,

professional, and ambitious pharmaceutical company with multiple growth

opportunities. Job opportunity includes competitive salary,

comprehensive benefits, performance package, and ability to be part of

an international leader in an expanding industry.

## Ready for the challenge?

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