QA Officer Operations & Compliance
1. Job title
QA Officer Operations & Compliance
Primary job function
- The QA Officer Operations & Compliance is responsible for ensuring that the distribution processes, product finishing processes and related processes are in compliance with the specifications and regulations to ensure product safety and patient safety. The QA Officer Operations & Compliance also advises site staff, on how to execute these activities.
Core job Responsibilities (major accountabilities)
- 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) to ensure product safety and patient safety.
- Continuously evaluates the performance of the quality system and supports and implements improvement programs.
- Complaint handling processes – Responsible for logging and follow-up on supplier complaints & participation in complaint investigations.
- CAPA Management – Participates in the site CAPA management process.
- External Auditing - Supports auditors in the effective and efficient execution and documentation, investigation, impact assessment, and corrective/preventive action.
- Supplier management - responsible for performing and follow up of the supplier audit program.
- Internal Auditing – act as internal auditor.
- Support the IT system related to the assigned quality system including identification, planning and execution of appropriate training.
- Support all QA related Product Finishing activities in line with GMP, including batch release documentation.
- Support all QA related distribution activities.
- Act as product action officer in weekly duties of 7 calendar days, accessible 24/7.
- Act as back up for the training coordinator within the Learning Management System for ALOG Breda
- Act as back up for the document control coordinator role, including the creation on all QA related procedures and policies in line with AQR- and AN policies.
- Minimally a MBO level 4 is required. 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.
- 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.
Business knowledge & experience
- Total combined years of 3 years in one or more positions directly related to quality assurance / quality control preferred in food or pharmaceutical industry.
The base pay for this position isN/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
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable