Quality Assurance Senior Officer
Pharmathen, Netherlands

Due to continuous growth and expansion, Pharmathen Global BV offers a great opportunity for career development in the Netherlands and is seeking to recruit a Quality Assurance Senior Officer to join our team located at Amstelveen with the prospect of growing into a (deputy) Responsible Person for Good Distribution Practices.

As a Quality Assurance Senior Officer, the ideal candidate will support the Responsible Person for GDP with the implementation of the Quality Management System of the company.

He / She will be responsible for supporting the safeguarding of product users against potential hazards arising from poor distribution practices ensuring that the company demonstrates GDP compliance and that public service obligations are met.

What you’ll do:

• Follow the Company's Quality Policy and GDP policy and comply with current operational standards and legislative requirements
• Work in compliance with the requirements of the written GDP-Quality Manual, the written SOPs and the rest official documented policies of the company, that are related to the duties of the described position
• Ensure that the provisions of the license are observed, the operations do not compromise the quality of medicines and that an adequate quality system is established and maintained
• Oversee audit of the quality system and carry out independent audits
• Ensure that adequate records are maintained,
• Ensure full and prompt cooperation with product license holders in the event of recalls, whenever required
• Handle and manage of quality distribution records, included but not limited to shipment documentation, personnel training procedures, medicinal products recalls amp; complaints, qualification of suppliers amp; customers, self-inspection procedures
• Review documents related to product shipment for approval by the RP
• Handle and manage of main quality system’s processes, included but not limited to Deviation Investigation Reports, Change Controls, CAPAs
• Work closely with external consultants in the interaction with Dutch regulatory authorities
• Ensure the lawful supply chain, storage and distribution of pharmaceutical products and APIs (in stock, commercial, returned, rejected, recalled, falsified) and monitor their status in accordance to GDP requirements
• Coordinate the contracts’ agreements’ development, in relation to QA aspects, between the company and any third parties and ensures the proper record keeping (maintenance)

Requirements

The ideal candidate should have:

• Educational background in Chemistry, Pharmaceutical sciences, or relevant field
• Minimum 2 years of experience in Quality Management within a Pharmaceutical Industry or relevant department in the Pharmaceutical Industry
• Expertise, experience, and knowledge regarding GDP; GDP certification will be considered an asset

Job-Specific Skills:

• Ability to prioritize work and meet deadlines
• Multi-tasking
• Integrity amp; ability to properly assess the commercial considerations and arguments for maintaining quality
• Customer-focused with a flexible work attitude
• Strong communication and language skills
• Time management

Benefits

What you'll gain:

• Involvement in a high-caliber, team-oriented and dynamic atmosphere
• Exposure to challenging business issues and practices
• Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Please note: Applicants must be legally eligible to work in the Netherlands.

Submit your CV no later than 04/04/2021

Job Rewards and Benefits