Quality Manager / Pharma / Temporary / GMP and GDP / GxP / EQMS

Bedrijfsnaam: -
Plaatsingsdatum: 13/03/2019
Standplaats: -

Functieomschrijving

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Vlaams-Brabant Belgium.The CompanyOur client has been focusing on drug development and delivery. The purpose of this is to heal patients and improve their quality of life. The people of our client make the difference, together, they offer patients the best possible care.

Our client is a company who beliefs in achieving the best results by doing with each other. A real people-company!

Role DescriptionYour role as Quality Manager is ensuring that (new) regulations are implemented in the company. You also have to ensure the quality aspects through participation in cross-organisational projects, reporting systems and meetings. As Quality Manager you treat the external suppliers and partners directly connected to the manufacturing site with respect. Also all compliance issues including local quality systems in GMP and GDP and Regulatory matters. At last but not least, you promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel.

A role with a variety of tasks with a variety of responsibilities

ResponsibilitiesAs a Quality Manager with a variety of tasks, different responsibilities are added. Your responsibilities are:

• You will prepare and review the documents linked to the implementation of the Quality Policy and the Quality Management System (SOPs, WI’s…).
• You will implement correct written procedures, in conformity with the internal and international guidelines.
• You will guarantee that a good documentation system is in place.
• You will participate in solving different problems and support for corrective actions in the GxP areas.
• Organisation and performance of Quality Management Review.
• Organisation and performance of self-inspections in GxP relevant areas.
• You will report to the Global Operation Quality: Monthly reporting, inputs to annual report KPIs and Product recall reports.
• QA function with respect to external suppliers such as qualification, audits and quality agreements.
• You will provide help for the establishment of Quality Agreement with the clients partners.
• Act as expert in quality processes tracked in EQMS.
• Participate in the periodic review of the Quality Manual.
• Monthly reporting to Global
• Maintain your knowledge level by suitable training:
• Participate in initial and continued training and qualification activities as required for the job function
• Complete training within the specified timeframe
• Complete all required training prior to performing assigned regulated job activities and work under supervision until qualified to work independently
• Document completed training per local requirements
• Seek clarification as needed to ensure understanding of job requirements and applicability of training completed
• Demonstrate knowledge or skills gained from completion of required training and qualification
• Participate in retraining when there is a knowledge or skill gap and when required refresher training is offered by client

RequirementsA hole list of responsibilities ask for a qualified person who embraces the role, is committed and who has the following requirements:

• Experience as Quality Assurance Officer or Manager
• Fluent in English and Dutch (both verbal and written), French is a plus
• Ability to work easily with digital platforms
• Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and
Regulatory Affairs.
• Experience in a pharmaceutical environment is required
• Autonomous and assume responsibilities
• Analytical mindset
• Decision making based on scientific aspect and risk evaluation

Other informationPssst.... This is a good company to have as reference on your CV as consultant. Just saying! Don't miss the opportunity!

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.

 

Aanbod/arbeidsvoorwaarden
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Samenvatting

Plaatsingsdatum :
13/03/2019
Referentienummer :
97763
Standplaats :
-
Adres :
-
Postcode :
9723 HK
Opleidingsniveau :
HBO
Uren :
Nader te bepalen
Dienstverband :
Detachering
Werkervaring :
3 - 5 jaar
Contactgegevens :
bekijk