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14 Сеп 2017 | Показана 1293 пъти


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  • Position (Job title):
  • Position profile:
    Manufacturing,  Pharmaceutical industry
  • Ref. No:
  • Responsibilities:
    Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a new division to support Third Party Operations (TPO). In this regard, we are looking for an experienced and responsible professional for the position MANAGER LAUNCHES AND SWITCHES to join the TPO division.

    The Manager Launches and Switches will be responsible for warranty of the current pharmaceutical standards, statutory and regulatory requirements of products for Launches and Switches and ensures that all key projects regarding all quality issues are in compliance with regulations and corporate standards.

    • QA Due Diligence
    - Evaluation of a new supplier and/or manufacturer, respectively of a new product foreseen for licensing in. 
    - Performance on the basis of already available documents in combination with practical observation of the business with this manufacturer (e.g. SWOT).
    - The goal is to give proof if a certain contract manufacturer is able to follow global company’s standards. 
    - Evaluation of the current cGMP (Corporate Good Manufacturing Practices) and audit status. Participation in on-site audits, if required.

    • Regulatory compliance
    - Ensure that all regulatory variations were done with the contract manufacturer; conduct RA (Regulatory Affairs) maintenance; insure that all available documents are of the current status. 
    - Coordination of analytical methods, transfers and stability tests (bulk and OGS).

    • Supplier Qualification
    - Ensure a proper supplier qualification that manufacturing, packaging, testing and release is done according to cGMP rules, and the relevant Marketing Authorization and all regulatory requirements are met. 
    - Supplier Qualification is based on a Supplier Due Diligence Procedure. 
    - Ensure launch projects are delivered on time and meet the target success criteria regarding all quality issues. 
    - Participation in NPI (National Provider Identifier) TPO Meetings, PLT (Platelet)

    • Product evaluation and commitment to market release / batch release: initiation and deadline monitoring of all quality relevant activities.

    • Manufacturing Process Validations: evaluate the manufacturing process validation to ensure the robustness of the product.

    • Tech Transfers /Switches
    - Coordinate the know-how transfer from one production site to another site and/or switches of an existing marketing authorization to another registration. 
    - Ensure that cGMP rules, the relevant Marketing Authorization and all regulatory requirements are met. 
    - Participation in Transfer Project Meetings.

    • Degree in Pharmacy, Science, Engineering or similar
    • Pharmaceutical manufacturing or validation related experience
    • Analytical control of drugs and regulatory compliance experience
    • Experiences in statutory and regulatory requirements and guidelines of pharmaceutical products
    • Results and customer oriented professional with good analytical and communication skills 
    • Ability to work under pressure with tight deadlines
    • Very good in written and spoken English
    • Willingness to travel, also international 
    • Proficiency in MS Office, SAP and Track Wise®

    • Chance to join a global pharmaceutical company
    • Professional working environment providing opportunities for development
    • Competitive remuneration package

    Should you see yourself in the described role, please send us your updated CV in English. Only short-listed 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 №2311 issued on 13.07.2017, valid indefinitely.
  • Experience on a similar position:
    3 год.
  • The offer is valid for the following cities:
  • Job status:
    Пълен работен ден
  • Job type:
  • Documents for application:

  • Preferred way of receiving the applicants' documents
  • Deadline for application:
  • Company name: WYSER

    Industry/business sector: HR

    Additional information: Wyser is an international company oriented in searching for and selecting specialized middle and senior management. Wyser is presented in Europe, South America, North America and Asia and we work with companies and candidates in over 40 countries across the world. Wyser is a part of Gi Group, one of the major international leaders in the field of services specially dedicated to labor market development. Our mission is to translate our clients’ recruitment needs into projects, creating virtuous circles between valuable candidates who want to grow and companies interested in hiring the best leaders and most promising talents. In our work, we are stirred by the desire to build up long-term relationships with our partners, accepting their challenges with enthusiasm and supporting them in finding successful solutions together. We follow every project with a strong focus on the objective, and with dedication, competence, professionalism and confidentiality, towards both candidates and client companies. We are well aware how important work is for every individual. And we believe that the value of a company is always measured by the potential, talent and value of its people.

    Mailing address: 84 Al.Stamboliyski Blvd., Sofia 1303

    Е-mail: office.bg@wyser-search.com

    Telephone number: 02/9802620, 02/9807688

    MORE ON THIS COMPANY IN: Форума, Съдържанието на сайта, Capital.bg, Dnevnik.bg

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