Сряда, 26 Юли 2017 г.
новини от последните 24 часа: 945
Лупа
Manager Stability 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) on EMEA level. In this regard, we are looking for an experienced and responsible professional for the position MANAGER STABILITY to join the TPO division.

MISSION OF THE ROLE:
The main role of the Manager Stability Quality (TPO) will be to ensure the highest quality of all pharmaceutical products which comply with national law and internal guidelines as well as independent planning, organization and evaluation of stability. The candidate will be an authorized decision maker with regards to the corrective and preventive actions.

RESPONSIBILITIES:
• Planning, organization and conducting of stability studies (e.g. ICH, OGS, stress tests, transport stability studies to identify the maximum holding time for finished products and their intermediates).
• Creating of reports and statements for a comprehensible evaluation of the study in an authority layout as basis for the submission of marketing authorizations and variations or for the reply to letters of deficiency.
• Supporting of root cause analyses with regard to quality-relevant deviations (e.g. OOS with the aim to evaluate the risk to the quality of the product and to return to GMP-conform situation within stability control.
• Independent evaluation of deviations and decision over the usage of batches in order to keep time lines.
• Participating in risk analyses in order to evaluate the impact of deviations of the product’s quality in collaboration with the QA Officer.
• Defining of actions (CAPAs) with regard to scope, responsibilities and time line in order to eliminate the risk of a repeat of the same deviation in collaboration with the QA Officer incl. follow-up of the taken measures.
• Taking part in evaluation with regard to the PQR (Procedure Qualification Records) process and of KPIs
• Assisting with product-related reports to QA Officers, QPs or team leaders in case of quality deviations during the active stability studies in order to take decisions with regard to usage, necessary actions for product optimization and variations if applicable.
• Participating in the preparation of the department for audits and inspections

REQUIRMENTS AND COMPETENCIES
• University diploma in natural sciences or related disciplines
• 5 years of experience in the Pharmaceutical, Healthcare, Medical devices, Food & Beverage Cosmetics fields
• Experience in the field of quality control ideally with regard to stability testing
• Good software knowledge of MS-Office and ideally SAP Business Warehouse and TrackWise
• Good command of the written and spoken English language
• Strong ability to work under pressure, to take the initiative and to work in a team and have a strong sense of responsibility
• Cooperative communication skills
• Ability to explain complex situations understandably and solve problems
• Willingness to take decisions
• Knowledge about analytical methods and technics
• Ideally technical knowledge of production steps and the resulting manufacturing descriptions

THE COMPANY OFFERS
• Challenging and interesting position in a multinational company
• The opportunity to build and implement strategies and have an impact on the business
• 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