Quality Assurance Manager - Etten-Leur, Nederland - Tjoapack

Tjoapack
Tjoapack
Geverifieerd bedrijf
Etten-Leur, Nederland

4 weken geleden

Daan Van den Berg

Geplaatst door:

Daan Van den Berg

werver van beBee
Beschrijving

Position background
In the role of Quality Assurance Manager, you'll assume responsibility for overseeing the quality of our products and services. The activities encompass monitoring quality through visual, physical, or microbiological controls, as well as data verification.

Within this QA team, there are five primary focus areas:


  • Assessing incoming release of bulk products and components
  • Reviewing batch records, including pre and postproduction checks
  • Handling deviations and complaints
  • Managing Product Quality Reviews (PQRs)
  • Continuous improvement projects including change management
As the Quality Assurance Manager, you'll lead a team consisting of QA Officers and QA Employees.

Your role involves managing resource allocation according to business needs and collaborating with stakeholders such as Operations to address quality and compliance issues.

This includes managing deviations, change controls, complaints, and Corrective and Preventive Actions (CAPA). In this role, you will report to the Director of Quality.


Your responsibilities include

In this role, you will be instrumental in developing, implementing, and maintaining quality assurance policies and procedures to ensure compliance with all relevant standards and regulations.

You will manage and lead a team, fostering a culture of excellence and accountability.

Your ability to drive change management initiatives will be crucial as you collaborate closely with operations to resolve quality and compliance issues, taking the lead in various investigations as needed.


Below are the responsibilities include:

  • Take ownership of customer complaints management process, conducting thorough investigations and implementing corrective actions.
  • Conduct Root Cause Analysis (RCA) and manage Change Control (CC), Corrective and Preventive Actions (CAPA).
  • Establish quality metrics and benchmarks for product and service enhancement.
  • Conduct regular audits and selfinspections to identify improvement areas and address nonconformities.
  • Monitor order processing activities for accuracy, timeliness, and compliance.
  • Analyze order data to optimize processing workflows and enhance customer satisfaction.
  • Support Lean Transformation, drives continuous improvement initiatives within the QA activities, and drive together with production management reduction of repeating events.
  • Manage training programs, onboarding processes, and team performance.
  • Lead projects, manage employees, and hold budgetary responsibility.

Our offer
We will help you become successful in your new job with a customized development plan. At Tjoapack, we work hard, encourage innovative ideas, and give freedom to work independently.

Our working conditions include 30 days off, an attractive pension and a yearly salary increase depending on your performance.


Place within the organization

Tjoapack is a global contract packaging organization (CPO) specialized in primary and secondary pharmaceutical packaging and supply chain management services.

We're dedicated to shaping the future of the pharmaceutical supply chain to be safer and more reliable for our customers and for patients.

With more than 30 years of track record in contract packaging, we use our knowledge and experience to offer flexible solutions to our customers challenges and use the latest technologies to continuously improve our operations.

We now supply products to over 45 countries across all continents.


As the Quality Assurance Manager, you'll be part of the Quality Unit, which is at the heart and head of our total quality vision and mission.

It is the Quality Unit's responsibility to make sure that our people, processes, materials and machines work together to assure patient safety.

You will report to the Director Quality Assurance.

A TMA Analysis is part of the selection criteria.


Your background, qualification and skills

  • Master's degree in a technical or scientific field, or Bachelor's degree with relevant work experience.
  • Proficiency in pharmaceutical environments, particularly Good Manufacturing Practice (GMP).
  • Strong track record in investigating and resolving complex issues, utilizing methodologies such as root cause analysis.
  • Exceptional decisionmaking abilities with a focus on risk management, including familiarity with tools like FMEA.
  • Proven leadership skills in guiding teams and individuals towards growth and professional development.
  • Experience in planning, scheduling, and monitoring work to meet quality and time targets.
  • Proficiency in utilizing data for optimization projects.
  • Possess a continuous improvement mindset, preferably with Lean Six Sigma green belt certification or equivalent experience.
  • Customeroriented and serviceminded approach.
  • Effective communication skills across various levels and departments, both internally and externally.
  • Fluent in both Dutch and English.
  • Experience with Tableau is advantageous.
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