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QC Incoming Control & Supplier Management Inspector in Oss fulltime

Laboratory, Quality Assurance, Supply Chain
Netherlands, Oss
Fulltime
V-51616
Competitive
This company is dedicated to promoting global wellness. Their extensive range of medicines, vaccines, biological therapies, consumer care and animal health products are used in more than 140 countries. They are committed to improving access to healthcare through comprehensive initiatives where their products are donated and distributed to people in need. With more than 6,000 employees across five locations in the Netherlands, this company is at the forefront of innovative healthcare solutions.

Quality Operations (QO) 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.

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.

Products/Results Key activities

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 compliance.
• 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, raising concerns if needed or directing users to do so. Partner with relevant internal and global groups (e.g. FDA, EMEA) for building, maintaining and sharing knowledge and information.

EHS Responsibility

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

Contacts:

Internal:

• All functional areas (IPT, CoEs – Quality, IT, SCM, Eng – and other departments)

External:

• The different sites.
• Contract Laboratories.
• Regulatory agencies, inspectors.

Education, skills & competences and experience

Educational background:

• Experience in the pharmaceutical industry and cGMP is preferred, with a minimum of 5 years for candidates holding a Senior Secondary Professional Educational level (Dutch: MBO/MLO) in Science, or a Bachelor’s degree (HLO) in Biotechnology, Chemistry, or related fields, with a minimum of 3 years for the latter.

Skills & competences:

• Continuous Learning Attitude and preferable MPS/Lean Six Sigma.
• Basic knowledge/overview of 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.

Dionne Vreeswijk

Recruiter
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