Quality operations support (Fixed night)

The purpose of this position is to provide support to the operations department by being involved in quality activities and addressing quality issues. It also includes responsibilities such as thoroughly reviewing batch documentation and handling the administrative release of batch records.

• Quality follow-up in the form of checking batch records for correctness and completeness, both during and after production within agreed deadlines.
• Control of variable data and allocation of bulk and other materials in production orders.
• Carrying out line clearances (cleaning/line clearance + 1st product check) for start-up production orders
• Reconciliation verification (document review) and blocking the line when an order is turned off.
• Issuing logbooks as logbook manager and page review of logbooks. - Blocking goods, materials and products that do not meet specifications, and defining corrective and preventive actions. - Reviewing new quality documents such as Batch Records, Line Clearance and Cleaning records for GMP and quality aspects from QA responsibility.
• Submit completed batch records to the QP for approval; - Monitor GMP level on the shop floor (GMP monitoring) and suggest optimisation/improvement of overall quality and production processes. - Managing and recording reference, retention and reserve samples, preparing them for dispatch or storage in the RS area where necessary or preparing them for examination of samples by the QP. - Stopping a production process and taking measures in cooperation with production supervision if in a production process the set specifications and controls are not met. Taking immediate action on this to resolve these deviations (or have them resolved). Immediate reporting in case of serious incidents and discussing quality deviations with superior and QP.
• Conduct investigations following quality incidents and provide input for corrective actions.
• Carrying out internal inspections
• Training employees a.o. in line clearance verification, logbook completion and GMP/GDP.
• Provide support to other sub - departments within the QA (Operations) group.
• Help ensure and observe an optimal level of quality, safety, order and cleanliness, general operation (including company rules), cooperation, working conditions and atmosphere.

• Min. upper secondary school diploma
• Several years of experience in the quality department in a manufacturing company (pharmaceutical or food sector preferred)
• Very good command of Dutch language, good knowledge of English language
• Good knowledge of cGMP and GDP
• Good knowledge of MS Office (Word, Excel)
• Accurate and strongly analytical
• Driven and proactive work attitude
• Strong sense of responsibility
• Good powers of persuasion and a positive attitude
• Good at both oral and written communication
• Able to work well independently as well as in a team
• Quality and service-oriented
• Solution-oriented thinking and action
• Be able to plan and organise own work, paying attention to deadlines and priorities

This company operates within the pharmaceutical industry.

They strive to create a working environment where all employees can use their skills to the fullest.

You will be offered a versatile and challenging position in a dynamic working environment and create numerous career opportunities.

You can count on a suitable salary complemented by numerous benefits such as group and hospitalisation insurance, meal vouchers, gift vouchers and other benefits.

Questions or interest?

>> 014 33 75 67 

>> lommel@ctrl-f.be

>> WhatsApp: 0477 71 16 88