Analytical Project Leader

il y a 3 semaines


Thuin, Belgique Quality Assistance Temps plein

We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to **evaluate the Quality, Safety and Efficacy of drugs**.

As part of our business growth and with a view towards a major expansion of our laboratories, we are looking to recruit an **Analytical Project Leader**.

**Your mission**:
You will report to the Project Team Manager who coordinates the Project Leaders.

In this role, you will **manage and coordinate laboratory projects outsourced by our clients** and you will serve as the **main point of contact**.

You will ensure the following tasks:

- Write technical agreements
- Coordinate the planning of the work in collaboration with the laboratory team
- Supervise the allocation of the samples and reference standards
- Monitor the execution of all project-related activities
- Ensure protocols and contracts are respected
- Manage communication internally and externally with clients
- Review final reports: trend analysis, conclusions, conformity of Quality Assurance documents, conformity with the technical agreement, etc.
- Manage project-related quality documents in collaboration with the laboratory teams and the Compliance Department
- Maintain records and files
- Participate in audits and clients visits

**Your profile**:
**Scientific background** (PhD or Master's degree / Engineer)

**Required**:

- Work experience in the pharmaceutical industry in a regulatory environment (GMP, GLP, GcLP)
- Experience in project management in a laboratory environment
- Excellent communication skills in French and English (B2 level)
- Strong organisational skills with the ability to manage projects through wise planning, time optimisation, detail orientation and priorisation
- Team player

**Why join Quality Assistance?**:
Do you want to thrive in a professional setting that still maintains a human touch? Are you looking for a working environment based on mutual respect, communication and support, where it is good to live and work?

You will benefit from a **competitive compensation package** in line with the industry, including **many fringe benefits** (meal vouchers, hospitalisation and outpatient care insurance, group insurance, bonuses, and for certain positions, a company car and petrol card).

As soon as you start your job, you will follow a comprehensive** training programme adapted to your profile and role.**

We offer **multiple opportunities** so that you can integrate yourself into your new work environment and get to know your new colleagues (after-works, sports and recreational activities, team building, department dinners, end-of-year parties, BBQs, events for families, etc.). **We pamper our team members and take care of them**: free sports lessons, free fruit and sugar-free drinks, daily delivery of lunches and bread, free car wash, ironing service via service vouchers, books and board games available, and much more.

**You will join a company that listens to your needs and your suggestions**

**About Quality Assistance**:

- Quality Assistance_ is a **leading European Contract Research Organisation** (CRO) providing the pharmaceutical industry with **all the analytical services **required by **EMA** and **FDA **regulations for the development and marketing of innovative human medicinal products.
- We define **analytical protocols;**
- We develop and validate** specific new analytical methods;**
- We perform **characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing.**

These tests are performed in order to evaluate the **Quality, Safety and Efficacy** of the given drugs.

With more than **40 years’ expertise** at the forefront of analytical sciences, _Quality Assistance_ holds a **unique place on the market thanks to**:

- **all of its laboratories located on one site** (Donstiennes, Belgium);
- **250 highly qualified professionals;**
- a** wide range **of analytical methods and state-of-the-art equipment.

The _Quality Assistance_ environment is **GMP, GLP and GCLP/GCP compliant.


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