About this job
- Branche: Pharmaceutical
- Area of expertise: Regulatory
- Location: Leiden
What is required?
- Hours per week: 40
- Education level: Academic Bachelor
- Closing date: Friday, May 14, 2021
About this role
For our international pharmaceutical customer we are looking for the Quality Systems Document Control Associate to join and strengthen the team.
Quality Systems Document Control Associate is responsible for the development and maintenance of the Quality Management System (QMS) Document Control system supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs, and other functions that utilize the Medical and Development QMS. The specialist contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.
Your responsibilities include:
- Act as the Quality Document (QD) Administrator responsible for reviewing new or revised Quality Documents for compliance to established standards.
- Ensure all Quality Documents meet required standards before processing documents in the Document Management System - Quality Document (ADMS QD) workflows.
- Ensure impacted stakeholders are involved in the review of new and revised Quality Documents.
- Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the customer's Document Management System - Quality Document (ADMS QD).
- Support the development, review and delivery of training materials to provide to new users of the ADMS QD system.
- Provide guidance on proper methods for writing SOPs and other
- Quality Documents to meet standards.
- Support Document Control initiatives that lead to process improvements.
- Respond to email inquiries and user support questions.
- Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository
- Bachelor of Arts/ Bachelor of Science degree BS/BA.
- 2 - 5 years working experience in the pharmaceutical industry, one of which should be within Quality Assurance and/or within SOP writing, Process Improvement or similar discipline.
- Proficiency in Microsoft Office.
Brunel offers outstanding individuals a highly diverse and challenging job opportunity in a company where an open, professional and pleasant working culture is greatly valued; where your personal initiatives will be noticed and rewarded; and where you will receive all the support, coaching and training you need for your future career. This is your opportunity to discover a wide range of sectors and activities and develop your expertise in a fast-moving and results-oriented environment. Being intermediated by Brunel means that you are contracted by Brunel. Not only you will have a contract, you will as well be assured of a great career! Our primary and secondary terms of work are excellent. A few examples are price reductions at CZ Health Insurance, bonus opportunities and standard 26 days off. Brunel Engineering intermediates both junior and senior engineers within the industry for over 30 years now. Our clients vary from multinationals to local companies. Together we will find the job which meets your wishes.
Join the Brunel Community
Brunel is an international organization which can offer work on exciting and challenging projects in collaboration with our partners within various industries. These sectors offer opportunities to participate on the development of new technologies amongst world class organizations. Our industrial partners seek the best professionals who possess the ambition and enthusiasm to excel. Brunel is an international provider of services specialized in project management, secondment and consultancy in the disciplines of Engineering, IT, Finance, Legal, Marketing & Communication, Healthcare and also all disciplines in the oil & gas industry. Since its establishment in 1975 Brunel developed itself in an international organization with over 11.000 employees. Brunel Engineering is specialized in secondment of technical specialist with a Bachelor’s, Master’s or Ph.D. in all technical fields. The sectors in which Brunel Engineering is active are High-tech, Production, Construction, Infrastructure and Industry. Brunel is also dedicated to the personal development of its employees and supplies them with an extensive training program.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.