Technical Writer

  • Location: Walloon Brabant
  • Type: Contracting
  • Job #15300

Technical Writer

Walloon Brabant – Contracting 

#Pharma #GMP #Quality #QA #Review #Documentation

You have a relevant experience in a quality position in the pharma industry?

You have a good knowledge of GMP requirements?

 

Our partner is looking for a Technical Writer to reinforce his team on a specific analytical digitalization project to increase efficiency, robustness and in time delivery of all the required information and deliverables.

 

What are your responsibilities?  

As Technical Writer, you will:

– Perform the authoring, reviewing and editing of various documents related to manufacturing activities (master batch records, training sheets, sops).

– Bring technical expertise and perform troubleshooting on the field if needed to solve blocking points on various analytical projects.

– Ensure that technical documentation is concise and understandable to readers.

– Coordinate with IPSA, production, process engineer, and compliance teams as needed to maintain consistency across documents within and across projects.

– Identify trends and differences between documents and recommend improvements to document templates and/or methods collecting/generating data sets.

– Drive the improvement and alignment of documentation in order to improve efficiency and readiness.

 

Who are you?  

You have a bachelor degree and minimum 2 years’ experience in a similar function. You are able to write/review various analytical equipment’s, manufacturing and training documents. You are organized and systematic mindset. You have excellent communication skills, as interacting with different teams/stakeholders. You are team player, autonomous and flexible. You speak French and are fluent in English (asset).

What can you expect?  

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job?

We kindly invite you to apply. Do you have any questions?

You can contact Nathalie Drayes, [email protected]

QA System Officer

  • Location: Walloon Brabant
  • Type: Contracting
  • Job #15097

QA Systems Officer

Walloon Brabant – Contracting 

#Pharma #GMP #Quality #QA #Deviation #Supplier #Audit

You have a relevant experience in a quality position in the pharma industry?

You are quality oriented?

Our partner is looking for a QA Systems Officer to support the QA Ops in the Manufacturing site.

What are your responsibilities?  

As QA Systems Officer, you will:

  • Implement and maintain efficient supplier’s evaluation process for equipment, consumables and services.
  • Leading or co-leading internal audits and supplier audits (audit survey).
  • As QA for the Supplier Evaluation Program, provide the information requested by the auditors during external audit and Inspection.
  • Manage of Deviation, Investigation and CAPA related to the supplier evaluation activities.
  • Organize and coordinate the GMP implementation of Pest control for the entire manufacturing site.
  • Maintain and continuously improving the Quality Management System and related processes.
  • Drive the identification of opportunities or improvement.

Who are you?  

You have a master degree or a proven experience in a regulated pharmaceutical environment. You have experience with Quality Management Systems and Auditing (asset). You can balance multiple priorities and have good oral and written communication skills. You are stress resistant. You are fluent in French and English.

What can you expect?  

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job?

We kindly invite you to apply. Do you have any questions? You can contact Nathalie Drayes, [email protected]

Clinical Supply Planner

  • Location: Walloon Brabant
  • Type: Contracting
  • Job #14888

Clinical Supply Planner

Walloon Brabant – Contracting 

#Pharma #GMP #Supply #Planning #IMP #Distribution #Demand

You have a relevant experience in a Supply Planning position?

You have experience in the pharma industry?

Our partner is looking for a Clinical Supply Planner to be responsible of the distribution planning, supply planning, inventory management and customer service level (product availability) of Investigational Medicinal Products (IMP) of our client.

What are your responsibilities?  

As Clinical Supply Planner, you will be in charge of the Clinical Supply Planning by:

  • Refines the IMP supply strategy to ensure adequate and sufficient forecasting of IMP.
  • Drive production plan, distribution plan and IRT settings throughout the study.
  • Be responsible for creating the IMP distribution strategy to ensure timely and cost efficient delivery to clinical sites using distribution requirements principles.
  • Manages IMP demand (forecast) and supply fluctuations.
  • Solve issues along the way, analyze the context, propose alternatives and reach out to stakeholders to seek collaboration with the end goal on meeting customer’s needs.
  • Orders packaging as well as resupplies for IMPs, and track releases.
  • Manages inventory, order movements of IMP through the established distribution network.
  • Coordinate and manage the project and the stakeholders.
  • etc.

Who are you?  

You have a bachelor’s degree and at least 3 years of experience on demand and supply planning in the pharma industry. You must have a previous experience in supply chain planning. You have a process/result oriented mindset. You are fluent in English (written and spoken).

What can you expect?  

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job?

We kindly invite you to apply. Do you have any questions? You can contact Nathalie Drayes, [email protected]

Quality Engineer

  • Location: Walloon Brabant
  • Type: Contracting
  • Job #14861

Quality Engineer

Walloon Brabant – Contracting 

#Pharma #Quality #GMP #Medicaldevices #Suppliers #Regulatory #LCM

You have a relevant experience as QA in the pharma industry?

You are quality oriented?

Our partner is looking for a Quality Engineer to ensure the technical quality and Life Cycle Management of drug delivery technologies and other medical devices for our client.

 

What are your responsibilities?  

As Quality Engineer, you will:

  • Maintain level of quality on the product on the market (medical devices – auto injectables);
  • Support activities related to complaints, change control, CAPA, deviations;
  • Support in the preparation of the annual product reviews of our products on the market;
  • Maintain the design history files (transition from MDD to MDR);

Who are you?  

You have a master’s degree and a proven track record in medical device development, industrialization, production, quality. You have a previous experience in technical/quality engineering activities (change control, CAPA, deviations etc). You have project management skills (planning, tracking, controlling, anticipating, etc). You have good regulatory knowledge and you are familiar with documentation. You speak French and English.

What can you expect?  

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. 

Do you have any questions? You can contact Nathalie Drayes, [email protected]

QA Manager

  • Location: Walloon Brabant
  • Type: Contracting
  • Job #14848

QA Manager for Biologicals

Walloon Brabant – Contracting 

#Pharma #QA #Quality #Biologicals #GMP #Regulations

You have a relevant experience as QA in the pharma industry?

You are quality oriented?

Our partner is looking for a QA Manager to provide advice and support on operational and general QA activities of our client.

What are your responsibilities?  

As QA Manager for Biologicals, you will:

  • Review and approve project documentation (technology transfer protocols and reports, manufacture and analytical testing, quality agreements, process development studies, stabilities studies, deviations, change controls, CAPA etc);
  • Check referenced documents and data;
  • Check compliance with relevant protocol/SOP/GMP guideline, regulatory guidelines;
  • Check that deviations and changes are properly addressed and documented;
  • Check that comments from review are correctly addressed;
  • Review and approve analytical, DS and DP CMC submission sections;
  • Work closely with Technical Operations teams to ensure that all QA services for the project are provided in an effective and efficient way.

Who are you?  

You have a master’s degree and minimum 5 years working in the pharmaceutical biologics industry in a QA position. You are able to interpret and applicate regulations together with quality principles and techniques. You have a knowledge of regulatory submission preparation, ICH Q2 analytical method validation principles, GMP process validation. You are problem solving oriented and speak French and English.

What can you expect?  

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. 

Do you have any questions? You can contact Nathalie Drayes, [email protected]