Assistant Production Services (12 months)


JOB DESCRIPTION


Function: Assistant Production Services
Reports to Supervisor Production Services

Objectives:
Administer the planning and control of documents generated by the production department (such as batch records, internal documents and logs), with the aim of ensuring the accurate documentation of production data, according to GMP and GDP standards.

Main tasks and responsibilities:
1.  Planning overview
Based on the prepared production schedule, ensure that all necessary documentation is created: batch records based on a week overview, request sampling plan from QC and incorporate obtained labels in the batch records, prepare planning suspensions and pass them on to logistics with the aim of ensuring efficient transport planning.

  • Example activities:
    Analyze production planning and pass on required information to involved services: e.g. QA, QC and logistics,...
    Request additional information if needed
    Compare production numbers with the planning and report deviations if necessary

2.  Production files
Prepare, compile and transfer the batch records, based on available reports in accordance with GMP and GDP guidelines and with QA approval, with the aim of giving the correct batch record to production.

  • Example activities:
    Downloading, adjusting and printing the batch records based on the planning overview and generating the report from the documentation system
    Requesting and distributing the sampling labels
    Getting reports approved by QA
    Passing the batch record on to production
    Maintaining and following up batch records (correction files, etc.)

3. Data entry
Creation, processing and closing of production orders and production data in the systems provided for that purpose (ERP, DMS), with the aim of ensuring traceability.

  • Example activities:
    Receiving and entering production data into the ERP and DMS systems
    Reporting of anomalous consumption and depreciations
    SAP: order processing from start (creation) to finish (closure)
    Keeping the recipes up to date in SAP

4.  Control reports
Checking and correcting batch records according to SOPs, GDP and GMP guidelines (presence of necessary signatures, times and lab data) and if necessary inquiring or returning batch records, with the aim of enabling a final check for transfer to QA.

  • Example activities:
    Check production records for adherence to SOPs, presence of necessary signatures, times, calculations and lab data (temperature, flow, conductivity, pH, etc.)
    Detecting, evaluating and signaling deviations and anomalies

5. Optimization
Reporting common problems, with the aim of contributing to efficient and effective processes/products.

  • Example Activities:
    Collecting frequently occurring problems and signaling them at the weekly follow-up meeting batch-record-review
    Identifying problems and deviations to the supervisor
    Search for improvements in the documents and working methods (usability, simplicity,...)


Profile:

  • You are in possession of a diploma of secondary education.
  • You have experience within an administrative function.
  • Experience within a production environment is a great asset.
  • Knowledge of Microsoft Office, SAP, Excel and Access are an asset.
  • You have a good knowledge of Dutch and/or French.  You have a basic knowledge of English.
  • You have an eye for detail and work accurately
  • You are systematic and structured.
  • You are a team player with strong communication skills.


Our Company 

Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions' mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya's slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people.


We offer

Prothya Biosolutions BE is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.

In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year.

We also offer an attractive holiday system exceeding the legal holidays.

Furthermore, we value mutual respect and diversity is our strength.

For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.

Are you interested? Send your CV and covering letter.

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