QA Officer Operations

JOB DESCRIPTION:

• The QA Officer Operations is responsible for ensuring that the distribution processes, product finishing processes and related processes and advises site staff, such as to execute these activities in compliance with the specifications and regulations to ensure product safety and patient safety.

• Contributes to the development and maintenance of the Abbott quality policies and systems to ensure that business objectives are met for the distribution programs for Abbott Logistics.
• Continuously supervises the processes related to the assigned quality system(s) and advises staff in relation to this system, on how to execute the applicable activities in compliance with Abbott policies and other applicable regulations (a.o. GMP/FDA/HACCP/MDR) and standards (a.o. ISO9001 & ISO13485) to ensure product safety and patient safety.
• Support the IT system related to the assigned quality system including identification, planning and execution of appropriate training.
• Support the doc control process including the creation on all QA related procedures and policies in line with AQR- and AN policies.
• Continuously evaluates the performance of the assigned quality system and supports and implements improvement programs.
• External Auditing - Supports auditors in the effective and efficient execution and documentation, investigation, impact assessment, and corrective/preventive action.
• Internal/Supplier Auditing - Responsible for performing and follow up of the internal/supplier audit program.
• Exception Management – participates in the exception management process.
• Participates actively in projects as project member.
• QA related Product Finishing activities in line with procedures and GMP.
• Support all QA related warehouse operations activities.
• Assuring execution and documentation of housekeeping, cleaning, pest control and security programs.
• Support complaint handling processes.
• Participates in validation projects; advises regarding classification and requirements for the performance of the validation of the systems/equipment. Reviews and authorizes validation protocols and reports. Is responsible for the final release of a system/equipment upon validation. And as such will participate in the Validation Review Board (VRB).
• Act as product action officer in weekly duties of 7 calendar days, accessible 24/7.

• Minimally a 4-year bachelor degree is required. (“HBO+” level). This is required to understand and manage the complexity of activities associated with the assigned Authorities and Responsibilities or a demonstrably equivalent level, obtained through additional training and proven work experience.
• Participation in multi-departmental project with demonstrated effective communication, teamwork and problem solving skills.
• Written and verbal communication skills in local and English language.
• Excellent knowledge of personal computer systems.
• Well versed in MS Office.
• Quality systems, quality assurance experience in an operational setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities is desired.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ANSC Nutrition Supply Chain

LOCATION:

Netherlands > Breda : Minervum 7201

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable