Vrabotuvanje.com - Head of Quality Control - Росоман - Синцеритас АД Скопје
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Росоман

Рок за пријавување:

  • Синцеритас АД Скопје
  • Адреса: Ул.Никола Кљусев бр.11, 1000 Скопје

sinceritas is looking for

Head of Quality Control

Refers to: COO
Replaced by: Qualified person 
Department: Quality Control
Location: Rosoman

The Head of Quality Control manages the Quality Control (QC) department and ensures the proper implementation of all QC programs and procedures for all new and existing products. Responsible for maintaining the stability program in compliance with global regulatory requirements. Provides technical expertise on the QC program and procedures in documentation. Ensures drafting, compiling and controlling of the product development documentation to support international product registration and market launch initiatives. Approves changes to QC programs and procedures, global stability program and global lab management systems. The ideal candidate is highly organized, has good regulatory strategic thinking, can adapt to changing priorities and demonstrates good communication, project management and problem-solving skills.

RESPONSIBILTIIES:

  • Complete management of the QC department
  • Designs and manages the QC department programs and procedures for all new and existing products
  • Implements improvements of the stability program, responsible for the assessment of the impact of changes on the overall stability program
  • Manages and controls product development teams in the development of product specification and analytical methods’ improvements
  • Participates in the preparation of regulatory submissions
  • Ensures that scientific data supporting submissions follow the domestic and international regulations and all relevant guidelines and policies
  • Responds to health authority requests in a timely manner
  • Manages and controls the implementation of the GMP compliance procedures
  • Development and validation of analytical methods for control of products
  • Participates in the Integrated Management System (IMS)
  • Other responsibilities related to the control and management of the QC programs and procedures, in accordance with candidate’s skills and qualifications.

QUALIFICATIONS:

  • Bachelor’s degree in pharmacy and Specialization degree in Examination and control of drugs at the Faculty of Pharmacy.
  • Minimum 5 years direct experience in drug development/quality control/stability centers related field; preferably in an international capacity.
  • In depth understanding of quality control procedures and relevant regulatory standards.
  • Strong understanding of regulatory requirements for movement of controlled/uncontrolled products between different global jurisdictions.
  • Strong ability to utilize statistical analysis tools and techniques for the evaluation of product shelf life and storage conditions.
  • Strong technical knowledge of product development, global regulatory requirements.
  • Strong knowledge of stability testing requirements of new drug substances and products.
  • Strong knowledge and background in CMC (chemistry, manufacture, and controls).
  • Extensive experience implementing and maintaining quality management systems and programs (ISO9001, GMP requirements)


 

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