Daily new jobs

 

QA/QP Specialist

Share on social media:

Apply Save this job

1 person also applied on this job


The company

Our client is a professional organisation, based in Noord-Brabant Netherlands. Our customer is one of the largest supplier of medicines in the Netherlands. This is a unique opportunity to work in one of the largest pharmaceutical companies in the world!

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

- 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

Requirements

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

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 Windimi Post.


Job alert

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

SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 17-05-2019
Country: The Netherlands
Region: Noord-Brabant
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Pharmaceutical
Specialisation: Quality

Search again

Related jobs

Thijs Claassen
Material Planner

The Netherlands
Permanent
Quality

Joost Spape
Interim Buyer Packaging (6 months)

The Netherlands
Permanent
Quality

Karim Oujalim
Kwaliteitsverantwoordelijke

The Netherlands
Permanent
Quality

SIRE Information Technology®
Senior Software Designer

The Netherlands
Permanent
Quality

SIRE Information Technology®
System Engineer IT&S Service Innovation

The Netherlands
Permanent
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 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 420 C
1016 GC 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

Product Price