Product QA Data Coordinator - Utrecht area in The Hague, Utrecht, Netherlands

Abroad Experience International Recruitment Agency

International non-profit organisation.

Overall Responsibilities

The Product Quality Assurance (QA) Data Coordinator is responsible to ensure documentation related to product specifications (pharmaceuticals and medical devices) submitted by potential suppliers align with quality requirements set forth in the Product Quality Policy or that of the client in terms of quality, safety, and efficacy.

The Product QA Data Coordinator is also responsible to verify all QA-related product information and enter product and registration into the item master database accurately. This role has direct communication with the suppliers, the Product Quality Assurance Manager, and the operations team, as necessary. The Product QA Data Coordinator is also expected to support the Product QA Manager in quality control activities by identifying product and supplier risk and running sampling reports to inform when orders have been flagged for routine sampling.

Additionally, the Product QA Data Coordinator is responsible for quality assurance oversight within the data management systems.


Specific Responsibilities

  • Ensure the item master reflects only approved products that are being procured and supplied to countries, in line with defined QA policy.
  • Liaise with suppliers to collect and update QA-related product information on a regular basis.
  • Coordinate and make changes in the item master in consultation with Product QA Manager.
  • Assign product and source risk profiles in the ERP system, in consultation with the Product QA Manager.
  • Run sampling reports to identify orders flagged for routine testing; and obtain approval from the Product QA Manager to notify appropriate personnel to organize sampling and testing.
  • Assist in the development and revision of the QA Unit-related standard operating procedures and work instructions in line with Quality Management System.
  • Ensure proper documentation and filing of QC analysis, sampling and GMP/GDP audit reports.
  • Trouble-shoot data issues, as they arise, and liaise with Product QA Manager and MIS team to implement necessary corrective actions to data management systems

Requirements

  • Bachelor's degree in Pharmacy, Chemistry, Public Health or equivalent degree
  • 2+ years' work experience in a health-related field.
  • Knowledge of quality assurance and regulatory affairs of pharmaceuticals and medical devices.
  • Experience working with an ERP and other data management systems.
  • Experience in Quality Assurance/Quality Control, GMP/GDP is a plus.
  • Knowledge of additional languages i.e. French or Spanish is desirable.
  • Solution oriented with a high sense of team, quality, attention to detail, accuracy, and efficiency.
  • Strong written/verbal communication, including presentation making, and interpersonal skills with strong sense of customer service.
  • Strong organization skills with an eye for details, ability to plan, prioritize, and implement day-to-day operations in a timely manner in a fast moving, dynamic, and time-bound environment.
  • Ability to work comfortably with common software, such as Word, Excel, and PowerPoint.
  • Willingness and availability to travel and perform other duties as required.

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