Вторник, 25 Юли 2017 г.
новини от последните 24 часа: 934
Лупа
Qualified Person in WYSER
Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a division to support Third Party Operations (TPO). We are looking for an experienced and responsible professional for the position Qualified Person (QP) for our client.

MISSION OF THE ROLE:
The Qualified Person is legally responsible for certifying that each batch of a medicinal product is suitable for release, for sale or for use in a clinical trial, and will be named on the manufacturer’s authorization. QP is essential in the quality assurance of medicines and is responsible for ensuring that good manufacturing practice is in place. If there are any changes in manufacturing or quality control, the QP will assess whether these impact the product quality. Strong leadership and oversight are necessary — before certifying a batch of medicine for release, the QP must be satisfied that all relevant checks and tests have been performed and documented.

RESPONSIBILITIES:
• Output of finished products to the market as per legislation
• Release of finished products for shipment for EU market according to EU legislation
• Analysis of claims and recalls, solving the deviation problems in laboratory and production, stability testing
• Take part in external and internal audits, technology conduction of new products in standard production
• Approve of annual product reviews
• Engage in implementation of supplier assessment system
• Operate on SAP improvements 
• Participate in change control activities
• Define of Quality agreements with contractors.

REQUIREMENTS AND COMPETENCES:
• Master’s Degree in Pharmacy
• 10+ years of progressive Quality experience in the pharmaceutical industry
• 3+ years as QP
• Ability to work with cross functional and global teams
• Capacity to manage in complex environment
• Good understanding of all aspects of the medicines manufacturing and supply chain.
• Competence to cooperate with individuals at various levels in the organization
• Fluency in English - verbally and in writing
• Excellent communication skills
• Solid influencing skills

THE COMPANY OFFERS:
• Challenging and interesting position in a multinational company
• The opportunity to be part of a brand new structure in the company and set the standard 
• Competitive remuneration package
• Regular trainings

If you recognize yourself in this position, please send us your CV in English. Only shortlisted candidates will be approached. All applications will be considered under the terms and conditions of confidentiality 
in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №1482 issued on 30.07.2012, valid until 30.07.2017
Обяви за работа