Analyst - Qc

**Job**: Quality Control Analyst - Operations - 2 shifts (Joblevel 6)

He/she reports to the Supervisor Quality Control.

The analyst works 2 shifts.

**Objectives**:
As a Quality Control Analyst, you will be responsible for carrying out complex Quality Control tasks, analyses and tests. You will provide technical support and training to less experienced colleagues, in accordance with GMP and safety regulations, guidelines and instructions received, in order to obtain the agreed results within the allocated time and according to the required quality requirements.

Main responsibilities:
1. You will independently carry out all Quality Control tests and analyses:

- You will evaluate the results and check them against the specifications and accepted limits.
- You will study anomalies (Event; OOS / OOL and ILI).
- You will draw up protocols for the qualification/validation of controls and standards.
- You will take part in projects concerning the validation.
- You will provide on-the-job training and professional support to colleagues.
- You will lead troubleshooting operations in case of problems with test methods and equipment.

2. You will be aware of instructions, guidelines and priorities, and will discuss and coordinate these with your line manager/coordinator.

3. You offer technical support and also provide information and support within your own department:

- You will be the point of contact for the day-to-day use and maintenance of laboratory equipment.
- You will be the point of contact for specific projects/tasks/non-routine work/deviations relating to assigned techniques/analyses.
- Thanks to your in-depth knowledge of analysis methods and the production process, you are able to determine the consequences of anomalies. You will also use this knowledge to support your colleagues.

4. You will ensure that documentation is accurate and correctly completed in order to guarantee the traceability of tasks carried out, in accordance with GMP procedures:

- You monitor events and carry out laboratory studies.
- You review analytical tests, both internal and external.

5. You identify risks in your own working environment and make proposals for improvements:

- You adapt QC procedures and documents (SOPs, specifications, sampling instructions, etc.) and keep them up to date.
- As a contact person, you will implement improvements to your own techniques.
- You will take part in projects relating to laboratory analyses.
- You will draw up CAPAs and follow them up.
- You will make proposals for improvements to the department’s operations and follow them up.

**Profile**:

- You have a bachelor’s degree in biochemistry, (micro)biology, industrial pharmacy or biotechnology or equivalent relevant experience.
- You should preferably have some experience in an equivalent role in the industrial sector (the pharmaceutical sector would be an advantage).
- You are familiar with GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures).
- You are fluent in English ; the knowledge of Dutch or French is an advantage
- You are meticulous and quality-conscious.
- You are flexible and willing to work in a team, including at weekends.
- You are able to manage priorities and are highly organised.
- You are communicative and confident in achieving objectives as part of a team.
- You are punctual.
- You notice dangerous situations, document near misses and take the necessary corrective action.
- You report any quality discrepancies to your line manager.

**Our company**

Prothya Biosolutions is proud to produce plasma-derived medicines that save lives

Every day, Prothya’s employees work harder to improve the health of millions of patients around the world. Are you looking for a job in a flexible, fast-growing company with an exciting history? If so, the Analyst role may be for you At Prothya, you can count on an attractive, safe and stimulating working environment, where everyone has the opportunity to give their best. The company also offers plenty of opportunities to develop, innovate and learn

**Our offer**

Prothya Biosolutions Belgium is part of an international biopharmaceutical group that offers long-term career prospects and actively invests in on-the-job training.

In return for your performance, you will receive a competitive salary, group and health insurance, luncheon vouchers and ecocheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible remuneration system that allows employees to create a budget from their current salary components. Through this plan, they can benefit, on a voluntary basis and according to their personal choices, from a series of advantages that Prothya Biosolutions Belgium offers once a year.

We also offer an attractive holiday scheme offering a greater number of days than the legal system and the possibility of teleworking after a successful integration (after 3 months).

What’s more, we value mutual respect and diversity is our stre