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Method Validation Supervisor

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The company

Our client is a professional Pharmaceutical organisation, based in Flandre Orientale Belgium. The company provides sales, distribution and support of pharmaceutical products in Belgium and in the Grand Duchy of Luxembourg.

The company undertakes to make first-line medicines available to the medical and pharmaceutical corps.

The company philosophy manifests itself in the following basic principles:

QUALITY
We attach great importance to delivering quality products that meet the needs of the market. We have all the trump cards for this: every step of the process, from production to distribution, is followed up according to strict quality standards.
 
 
TRUST
We make every effort to earn the trust of our customers, doctors, pharmacists or hospitals. To this end all forces are bundled, so that the delivered medicines are always of the same high quality and this at an acceptable price.
 
SERVICE and FLEXIBILITY
The satisfaction of our customers is the goal of all our employees. Our organization prides itself on its flexibility, because it places a high priority on service to its customers.

Role description

As an Analytical Development & Validation Supervisor, you lead an enthusiastic team of R & D analysts:

- you supervise the development and validation of analysis methods of medicines and methods for cleaning validations, you coordinate method transfer studies, the implementation of compendium methods (Ph.Eur., USP, ..) and other analytical tests to support registration dossiers.

Responsibilities

- you take care of the planning of the R & D lab, optimize the operation and thereby ensure compliance with GMP regulations.

- you manage the editorial work related to the R & D lab activities (protocols, reports).

- you take on the general organization of the lab (in which the stability team also works) and promote a positive working environment. You start an open communication.

Requirements

Master degree in pharmaceutical sciences, chemistry or equivalent. A number of years of relevant experience in method development and validation is required.

- you have excellent technical knowledge of chromatographic techniques (HPLC, UPCL, GC), various detection techniques and Ph.Eur./USP/BP compendia.

- you have experience with the development and validation of analysis methods. Knowledge of Empower3 (Waters) is a plus.

- you are very fluent in writing English scientific reports

- you are familiar with statistics and knowledge of relevant VICH / ICH / GMP regulations

- you strive for quality of the delivered work through accuracy, orderliness and accuracy.

- you already have a first experience as a people manager and have strong communication and organizational skills

- self-driven, proactive and enthusiastic are your core qualities

- you are positive, pragmatic and flexible with a correct focus on the company's interests

- you can work independently and set priorities quickly



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SIRE Life Sciences®

Ref. number: 41839
Listed by: SIRE Life Sciences®
Listed on: 23-07-2018
Country: Belgium
Region: Oost-Vlaanderen
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: Dutch
Sector: Pharmaceutical
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences Maastricht

ROOOMS Maastricht
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6211 AS Maastricht


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