Largest multinational logistics company (pharmaceutical business).
Main goal of the job:
To develop, implement and maintain the Quality Management System (QMS) (including constant improvement) specifically for pharmaceutical warehouse from scratch, in order to obtain own license for storage of pharmaceutical goods. Lead the licensing process and all coordination with Roszdravnadzor. Further to manage QMS on the pharmaceutical warehouse perimeter in accordance with the company strategy, general QMS book, customer requirements, with law and GDP/GMP.
Main tasks (all related to pharmaceutical perimeter):
Lead or participate to the start-up project through effective cooperation and support to all members of the process.
Close cooperation with engineering and construction group to align the requirements.
Preparation from the QM perspective for licensing including interaction with Roszdravnadzor. Design, implement and document procedures for process control, process improvement, testing and inspection in compliance with federal regulations including but not limited to GMP/GDP.
Management of trainings (creation, carrying out and evaluation), related to the requirements of QMS and licensing process.
Establish collection and analysis systems of statistical data to predict trends that will affect improvement of service quality.
Review customer contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans.
Interact with customers to identify opportunities to improve quality and establish feedback with service and development associates.
Supports operations and functional management in making sure of client satisfaction via:
o Analysis of the risks vs the requirements of the customer.
o Controls timely analysis of non-conformities and analyses the reasons for appearance.
o Implementing the necessary methods of control.
o Controls the corrective actions plan.
Report to management on quality issues, trends and losses.
Oversee calibration and testing programs.
Effective planning and management of internal and external audits:
o Monitor vendor performance.
o Establish criteria and rating system for critical vendors.
o Conduct supplier audits.
o Managing the corrective and preventing actions based on the results.
Compensation is discussed individually.
Extended social package (VMI, meal, mobile, laptop, etc.).
Professional growth is one of the corporate values.
Office located in Khimki region.
Profound knowledge in QMS (all necessary ISO standards, local legislation, GDP/GMP) and have experience as Quality Assurance Manager in pharmaceutical industry (5+ years).
Experience of start-up projects. Proven cases of obtaining pharmaceutical license.
Pharmacist qualification is highly preferred.
Good relationship with Roszdravnadzor.
Excellent communication skills (written and verbal).
Strong computer skills: MS Office and specific quality control applications.
Understanding of general safety requirement.
English – intermediate to upper.
Полная занятость, полный рабочий день, у работодателя