Responsible Person and Qualified Person

11-10-2018 wavre
company profile

Our client is a family and dynamic pharmaceutical SME which aims to place value-added and quality products on the market. They market a range of medicinal products, medical devices, food supplements and cosmetics, covering therapeutic areas such as rheumatology, gastro-enterology, dermatology and gynaecology

job description

Do you have at least 5 years experience in GDP and GMP as Qualified Person? Are you Fluent in French and English?
Don't hesitate to contact me: aurelia.sautiere@cx.ausy.be

The job is focused on medicinal products, and to a lesser extent on food supplements and cosmetics

* Assure the operational tasks linked to the responsibilities of RP deputy Benelux:
- Ensuring that a quality management system is implemented and maintained
- Focusing on the management of authorized activities and the accuracy and quality of records
- Coordinating and promptly performing any recall operations for medicinal products
- Ensuring that relevant customer complaints are dealt with effectively
- Ensuring that CAPAs, deviations and Change Controls are timely and efficiently dealt with
- Approving any subcontracted activities which may impact on GDP
- Ensuring that self-inspections are performed and necessary corrective measures are put in place
- Ensuring internal/external audit management
- Approving incoming medicinal products to saleable stock
- Deciding on the final disposition of returned, rejected, recalled or falsified products
- Ensuring that any additional requirements imposed on psychotropics by national law are adhered to

* Assure the operational tasks linked to the responsibilities of QP - Belgium only:
- Ensuring that repacking activities (limited to medical samples, secondary packaging and leaflets) are compliant
- Ensuring batch certification

your contribution

- Industrial Pharmacist
- 5-8 years experience in GDP and GMP
- Thorough knowledge of GDP
- Good knowledge of GMP
- Standard use of Microsoft Office applications
- Fluent in French and English. Good command of Dutch is an asset
- Strong written and verbal communication, interpersonal and customer-service skills
- Strong organizational, project management, time management, problem-solving skills and the ability to work accurately and meet deadlines
- Ability to work well independently, as well as part of a team
- Ability to exercise proactivity, flexibility, initiative, good judgment and discretion

what do we offer?

We offer an attractive salary with extra-legal advantages :
- Group insurance
- Hospitalisation insurance
- Meal vouchers of 7 euros gross per working day
- Reimbursement km or company car
- Monthly allowance (50 euros net per month)
- A 13th month
- Training
- Etc

summary
function
quality and environment specialist (m/f)
employment type
full time
contract type
immediate permanent employments
reference
CXRSP-74264
your Randstad contact
Aurélia Sautière
aurelia.sautiere@cx.ausy.be 0493/60.71.03
0493/60.71.03