Senior Laborant Qc

**Position**: Senior Laborant - Quality Control (FRAC)**

Reports to the Supervisor Quality Control (FRAC)

The Senior Laborant works in shifts

**Objectives**:
As a Senior Laborant - Quality Control (FRAC), you are responsible for performing Quality Control related tasks and routine automated analyses and tests as well as additional administrative work in accordance with GMP and safety regulations, guidelines, and instructions to achieve the agreed-upon results respecting the given time and quality requirements.

**Main responsibilities**:
1. You take note of and discuss instructions, guidelines and priorities with your supervisor and you make practical preparations to get a clear view of the work to be done:

- You take note of the samples to be taken and of the routine automated tests to be performed;
- You discuss the schedule and priorities with the supervisor;
- You receive, take an aliquot of and distribute the samples and store them according to the required temperature;
- You are responsible for drafting and designing new procedures/documents based on the new regulations.
- You are responsible for taking samples and performing routine automated tests and analyses such as pH, conductivity, sodium, TOC, and the dissolution of cryo-paste;
- You carry out an initial evaluation of the results and check them according to the specifications and limits;
- You help conducting research into deviations;
- You ensure the permanent monitoring of compliant material and check the stock.

3. You are responsible for storing and dispatching the samples according to the procedures, GMP guidelines and schedule.
- You store the samples in the serum bank according to lot number, process and code and you pack them to prepare them for transport according to procedure;
- You set up documentation and ensure the follow-up of shipments for external labs and the billing department;
- You monitor the transport and testing of the samples and take initiative when deadlines are threatened.

4. You ensure correct and accurate documentation during operations in accordance with GMP procedures:

- You are responsible for independently preparing, completing and delivering all relevant documentation;
- You file all documentation related to the tasks to be performed;
- You draw up an URS (User Requirement Specification) for equipment;
- You write new procedures or adapt existing ones;
- You draw up validation protocols and reports.

5. You provide technical support as well as information and support within your own department regarding the purchase, installation, (re)qualification and maintenance of existing and new equipment:

- You monitor and execute the process of purchase of new equipment (URS, qualification, matrix, IQ-OQ-PQ, final qualification);
- You take initiative in case of defects (minor repairs, contacting the company, documenting repairs, discuss (re)qualification with QA);
6. You ensure the quality and safety of the executed work and comply with the applicable legislation, standards and rules regarding the environment, safety, and quality:

- You ensure that you are adequately qualified to carry out tasks and can work in a safe manner;

7. You are co-responsible for the continuous improvement, identifying risks in your own work environment and actively provide input for improvement:

- You detect deviations in temperature and conductivity of water in order not to take unnecessary samples;
- You adapt procedures after approval of the supervisor/QA and keep them up to date;
- You propose simple CAPAs and follow them up;
- You provide improvement proposals for the operation of the department.

**Profile**:

- You have a Bachelor’s degree in Biochemistry, (micro)biology, Industrial Pharmacy, Biotechnology,or equivalent by relevant experience;
- You preferably have some experience in a similar position within the industrial sector (pharmaceutical sector is an asset);
- You have knowledge of the MS Office package; knowledge of LIMS/TRACKWISE is an asset;
- You speak Dutch or French, and can communicate in the other one, and have a good command of technical English;
- You are meticulous and quality conscious and are able to work independently;
- You are flexible and willing to work in a 2-shift system (6AM-2PM-10PM) and during the weekend (one day 2x/month)
- You are communicative and enjoy working in teams.