Quality & Compliance Specialist Customer Service

Quality & Compliance - Specialist Customer Service - Noord Brabant - 12 months

Amoria Bond is urgently looking for a Quality & Compliance specialist for a project of 12 months/a full year at an international biotechnical company specializing in human therapeutics.

You will be working closely with senior staff/experts within the organization to complete project activities, and participate in technical meetings as required.

The main focus will lie on ensuring quality of tasks/services provided by self and others, being accountable for budget, schedule, and results of a project team, and applying advanced knowledge of technical/administrative skills to leverage the skills of others.

Objectives of the project are:

*Set up and maintain a Compliance Program including NC/CAPA management in the Order-to-Cash environment
*Build and maintain relationship and structural alignment with International Quality and Country Quality Specialists
*Ensure Regional Supply Chain interest are taken into account in the cross-functional environment
*Overall ownership of the compliance program for Customer Service and Distribution
*Overall ownership of NC/CAPA for Customer Service and Distribution
*Ownership of change control records relevant to CS and Distribution
*Ownership of comprehensive investigation of NC's
*Ensure timely closure of NC's and CAPA's
*Coordinate compliance related improvement initiatives across OTC business units
*Act as one of the key liaisons between Regional Supply Chain and International Quality and Country Quality teams
*Ownership of Standard Operating Procedures, Work Instructions and Forms related to Customer Service and Regional Transportation
*Represent CS and Distribution during audits for NC/CAPA
*Perform NC trend analysis
*Establish and own compliance related reporting and dashboard
*Report out to management and key stakeholders
*Drive continuous improvement of NC/CAPA processes and SOPs
*Support Management in driving compliance across OTC processes and Regional Supply Chain functions
*Own and coordinate compliance evaluation related to the implementation of new processes or process changes
*Participate in internal and external audits as needed
*Provide training and counselling to Regional Supply Chain functions with regards to NC/CAPA outcomes.

Requirements

*Bachelor's degree or equivalent
*Solid knowledge of Quality Management Systems
*Experience in managing Supply Chain and Quality/Compliance relationships
*Solid knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), with the ability to interpret and apply in both routine and non-routine cases
*Knowledge of Change Control, Non Conformances, Process Monitoring, Investigations, Validation, Training.
*Fluency in English (oral and written communication)
*Ability to communicate cross-functionally and across levels
*Pro-active attitude and behaviour

Interested?

Candidates whom are interested or want to learn more about the role or position, can send an e-mail with their CV (in word-format) to Christiaan de Wit at (see below)

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Disclaimer:
Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age and experience, and we confirm that we are happy to accept applications from persons of any age and experience for this role.