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QA Manager & QP

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The company

Our client is a professional Pharmaceutical organisation, based in Oost-Vlaanderen Belgium. .

Role description

 Drug product development of new drug candidates focusing on difficult to formulate drugs that are in preclinical, phase I or phase II clinical development. The company offers a full suite of drug development services encompassing preclinical development, preformulation development, formulation development, analytical development, dosage forms development, scaling-up and GMP manufacturing of chemical and biologicals drug candidates

Responsibilities

 You implement, maintain and manage a GMP compliant Quality Management System for manufacturing and quality control of biological drug substances and related final products (buffer preparation, upstream and downstream processes) based on applicable regulations and guidelines.
 You manage the CAPA system: changes, deviation, non-conformities.
 You manage, support and coordinate risk assessments.
 You manage the supplier qualification process (materials and services).


 You support and review the qualification of production equipment, test equipment and cleanroom facility.
 You lead audits and inspections.
 You will review and approve batch records.
 You will release batches of biological intermediate products, drug substances and related final products (Investigational Medicinal Products).
 As a Qualified Persons you certify final products (Investigational Medicinal Products).
 You promote the awareness of quality, regulatory and customer requirements throughout the company.

Requirements

 Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline
 You are registered as a Qualified Person
 10 years of quality assurance experience in the pharma and/or biotech industry.
 Knowledge of GMP quality system and regulatory requirements (Eurdralex, ICH)
 Knowledge of biological process development and manufacturing is a real asset
 Excellent organization, facilitating and coordination skills. Ability to work independently as well as a member of a team in a dynamic environment
 Strong decision making and problem-solving skills
 Leadership skills
 Excellent oral communication, reporting and presentation skills
 Fluent in Dutch and English, written and spoken.

Other information



Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.

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SIRE Life Sciences®

Ref. nummer: 44940
Geplaatst door: SIRE Life Sciences®
Geplaatst op: 29-03-2019
Land: Belgium
Regio: Oost-Vlaanderen
Dienstverband: Permanent
Expertise: 6 - 10 jaar
Locatie Type: Op locatie
Opleiding: Master
Taal: Engels
Sector: Pharmaceutical
Specialisatie: 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 UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4630

SIRE Engineering

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650