Functiebenaming

Quality Control Specialist - III - LAB (O Support / Research) - O3

Start

1-4-2024

Categorie

Engineering/Technical/Quality

Beëindigen

31-12-2024

Type

Tijdelijk

Salaris

EUR 17,21 /uur - EUR 23,25 /uur

Klant

Merck Sharp & Dohme

Tarief Klant

EUR 34,39 /uur - EUR 44,93 /uur

Locatie

Netherlands - Oss

Status

Goedgekeurd

Benodigd

1

Job title: Quality Control Incoming Control & Supplier Management Inspector Level 2 (QC IC&SM Inspector Level 2)

Location:

Oss Bio Tech

Reports to:

Coach QC IC&SM

Division/Global Function:

MMD-Quality

Approval

Department (IPT/CoE):

CoE Quality Operations

Name first line manager:

A. Tax

Job code:

56152676

Signature first line manager:

Band / CCF level:

200 / O3

Date signature:

Organizational

Context

Quality Operations (QO) at MSD Biotechnology Operations Oss has the following thee sub-functions: Quality Compliance, Quality IPT and Quality Control. The Quality Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.

Job

Purpose

Executes incoming goods records review including correlating actions in other systems (SAP, GLIMS, etc.), release raw materials. Responsible for management and support for QNs and changes. Additionally, involved in Root Cause investigations, troubleshoot activities and involved in subsequent follow-up actions.

Quality Strategy

· Executes incoming goods records review including correlating actions in other systems ( SAP etc.)

· Release of incoming materials release and chemicals

· Performs IC&SM investigations, impact assessment (product, process, validation, etc.), Root Cause Analysis (RCA), investigation protocols and reports related to deviations.

· In co-operation with functional areas and in line with quality procedures and guidelines, supports the handling of deviations, including implementation of CAPA’s

· Responsible for management and support of incoming materials changes including writing and updating documents.

· Completes area documents associated to the product in compliance with site SOPs, Company Guidelines/ Procedures and local agencies regulation supporting business goals.

· Ensures quality concerns and/or opportunities are presented to management and/or project teams for prompt resolution

· Handles communication/issues to Contract Laboratories.

· Handles complaints to suppliers

· Supports the PQR process by delivering data

· Participates improvement projects

Compliance

· Responsible for initiating, revising and monitoring area procedures to ensure all is in compliance6

· Participates in Quality Area projects to develop and implement improved/lean processes.

· Identifies opportunities for improvement.

· Communicates any major or critical observations to management for proper immediate, interim and final action(s) to be taken to reach compliance.

· Change owner for area document changes

Guidance

· Participation in cross-functional/global teams

Administrative

· Assures that raw data are documented, reviewed and approved.

· Provides supports for QNs, follow up on QNs, CAPAs and Change Control.

Problem solving

· Provides day to day support for MSD Biotechnology Operations Oss, raising concerns if needed or directing users to do so. Partner with relevant internal and global groups (e.g. MSD, FDA, EMEA) for building, maintaining and sharing knowledge and information.

EHS Responsibility

· Responsible for actively contribution to realization of corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.

Educational background

· Senior Secondary Professional Educational level (Dutch: MBO/MLO), preferable in Science > 5 years experience in pharmaceutical industry and cGMP or Bachelor degree (HLO) preferable in Biotechnology, Chemistry, or relevant field > 3 years experience in pharmaceutical industry and cGMP

Skills & competences

· Continuous Learning Attitude and preferable MPS/Lean Six Sigma

· Basic knowledge/overview of MSD Biotechnology Operations Oss Quality Management System

· Basic knowledge of quality and compliance guidelines.

· Basic Technical knowledge in testing techniques

· Effective planning skills

· Computer literacy knowledge

· Strong focus on clients

· Ability to work under minimum supervision.

· Team work oriented.

· Strong communication skills, oral and written (in Dutch and English).

· Passion for continuous improvement

· Computer literacy knowledge

· Good communication skills

· Experience with documentation system and SAP is preferable

· Deviation management skills e.g. RCA, technical writing etc.

Experience

· See Educational background.

Employee Acknowledge if applicable

I certify that I received a copy of this document.

Name:

Signature/ Date: