Senior Quality Assurance Associate

Quality Nazareth, Belgium


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.


We are excited to be recruiting a Senior Quality Assurance Associate to join our Central QA team in Nazareth, Belgium. This position will report directly into the Quality Director and will lead a team of four dedicated QA associates. Your overriding responsibility will be to act according to the Quality Assurance vision, strategy and standards for the integrated Central Perrigo QA group. It will be your responsibility to ensure compliance with EudraLex Volume 4, ISO22716, EC1223/2009, ISO13485, and ISO14971.

Main Responsibilities:  

  • To lead one of the QA Operations teams supporting GMP compliance with regulatory expectations across multiple product types and internal categories
  • Ensure adherence to critical procedures and compliance to requirements for record retention.
  • Set up and maintain Quality Agreements with third-parties incl. contract manufacturers, logistic service providers, distributors. Be part of third-party qualification and regular third-party auditing.
  • Assist with due diligence and integration of new product developments / new product introductions for assigned categories.
  • Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers.
  • Coordinate Change control process and follow-up implementation of changes. Support technical transfers, qualification and validation work.
  • Assist in performing internal QA audits.
  • Support in the maintenance of the Quality Management System as required; creating and updating Standard Operating Procedures, Best Practices and Working Instructions.
  • Provide input to risk management plans and risk management files in line with ICH Q9 and ISO 14971
  • Provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness.
  • Assist in the GDP administrative batch control procedure.
  • Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
  • Provide evidence to perform review of implementation and effectiveness with regard to corrective and preventive actions..

Requirements:

  • Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry … or equivalent through experience.
  • Minimum 5 years relevant experience in Quality Assurance / Production.
  • Good knowledge of the relevant European regulations for pharmaceutical products.
  • Knowledge of FDA regulations for pharmaceutical products is an asset.
  • Previous people management experience is essential.
  • Self-starter, capable of working autonomously.
  • Clear communicator, practical and solution orientated.
  • Strong project management skills & team worker in a multicultural environment.
  • Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem-solving skills.
  • You are fluent in spoken and written English. Other languages are an asset

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.