Daily new jobs

 

QA and QP / Bio- Pharma / Temporary / nearby Breda

Share on social media:

Apply Save this job

2 people also applied on this job


The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Brabant Netherlands. Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands. This international company is leading in the field of human medicines in the biotechnology industry. The department in Breda has a challenging and interesting position for a QP/QA specialist.

Role description

In this role you act as a Qualified person, you are responsible for releasing finished drug product lots while ensuring compliance with the requirements of the marketing authorization and good manufacturing practices. As a Specialist Plant QA, you provide guidance and direction to Production, Maintenance & Engineering and Quality staff regarding compliance with quality standards and procedures.

Responsibilities

As QA/QP Specialist you are responsible for:

- You partner daily with production and engineering staff to support, enable and improve the production process
- You partner with production staff in performing risk analysis and the establishment of quality limits and requirements
- You own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training)
- You review and approve deviations and CAPA, initiate and own as needed.
- You perform impact assessment as part of change controls impacting production or QA processes
- You review and approve production equipment maintenance work orders
- You review and approve test protocols before use in production
- You perform GMP compliance checks in production
- You participate in internal audits and lead as appropriate
- Participate in regulatory inspections and partner audits
- You assist in development and delivery of GMP training for QA and production staff
- You lead and participate in Plant QA related projects/global QA initiatives as needed
- You lead and assist in various investigations as needed
- You assist in validation activities as needed including review and approval of validation documents

Requirements

What do you need to be successful in this role?

- Master’s in science in Pharmacy or equivalent
- Knowledgeable, skilled and eligible to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person).
- Thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation.
- Acquired practical experience in Good Manufacturing Practice (GMP) ideally in a Secondary Packaging manufacturing setting
- Fluent in English

Other information

The job is temporary with the duration of 52 weeks. Interesting? Apply!

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


Job alert

  • No registration required
  • Stay up-to-date on the latest jobs

SIRE Life Sciences®

Ref. number: 45606
Listed by: SIRE Life Sciences®
Listed on: 15-04-2019
Country: The Netherlands
Region: Noord-Brabant
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Pharmaceutical
Specialisation: Quality

Search again

Related jobs

Ewout de Jong
Longterm project: Compliance Specialist

The Netherlands
Freelance
Quality

Ewout de Jong
On site Quality Specialist

The Netherlands
Freelance
Quality

Ewout de Jong
Quality Assurance Specialist Orthopedics

The Netherlands
Freelance
Quality

Ewout de Jong
QA Complaint Handling Specialist

The Netherlands
Freelance
Quality

Joost Spape
Material Planner NPI

The Netherlands
Freelance
Quality

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