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OPEN POSITION: Quality Control Manager
News Open Position

OPEN POSITION: Quality Control Manager

Sinceritas is now accepting applications for the ‘Quality Control Manager’ position. Interested? Read more for details on responsibilities and needed qualifications.

RESPONSIBILITIES:

  • Managing the Quality Control (QC) Department and ensuring proper implementation of all QC programs and procedures for all new and existing products
  • Approving changes to QC programs and procedures, global stability program, and global laboratory management systems
  • Creating and managing the QC Department programs and procedures for all new and existing products
  • Implementing stability program improvements, responsible for assessing the impact of changes in the overall stability program
  • Managing and controlling product development teams in developing product specifications and improving analytical methods
  • Participating in preparation of regulatory submissions
  • Confirm that scientific data supporting the submissions follow domestic and international regulations and all relevant guidelines and policies
  • Timely responding to the regulatory institutions’ requirements
  • Managing and controlling GMP compliance procedures’ implementation
  • Developing and validating analytical methods for product control
  • Other responsibilities related to the control and management of QC programs and procedures in accordance with the candidate’s skills and qualifications

The ideal candidate is organized, manages projects well and has good strategic thinking in regulatory affairs. They have excellent communication skills, can adapt to changing priorities and has good problem-solving skills.

QUALIFICATIONS:

  • University degree in Pharmacy and specialization in drug testing and control
  • A minimum of 5 years of direct experience in the field of quality control/drug development/stability centers
  • Detailed understanding of quality control procedures and relevant regulatory standards
  • Detailed understanding of regulatory requirements for the movement of controlled/uncontrolled products between different global jurisdictions
  • Excellent ability to use statistical analysis tools and techniques to estimate product shelf life and storage conditions
  • Excellent technical knowledge for product development, global regulatory requirements
  • Excellent knowledge of requirements for testing the stability of new medicinal substances and products
  • Excellent knowledge and experience in drug control and production
  • Extensive experience in implementing and maintaining quality management systems and programs (GMP, ISO 900, ISO 17025)

The Quality Control Manager’s working hours are Monday to Friday, 08:30 to 16:30 at the Sinceritas Production Facility in Rosoman, Kavadarci.

If interested in joining #TeamSinceritas, please send your updated resume to hr@sinceritas.eu with the subject line reading: Application for the Quality Control Manager’s position

За да го прочитате огласот на македонски јазик, Ве молиме кликнете тука: https://www.vrabotuvanje.com.mk/Rabota/404837/Menadjer-za-kontrola-na-kvalitet/