Quality Director

OCTAPHARMA-PHARMIMEX LLC is a joint venture that includes two legal entities Octapharma AG and JSC “Pharmimex”. 
OCTAPHARMA-PHARMIMEX LLC has taken on the challenge to construct a production facility in Russia for the manufacture of life-saving, plasma derivative products out of plasma collected from Russian donors. 

Join us to become a part of a unique project, the construction of the first greenfield site of the Octapharma and the first production of blood plasma products in Russia.

What will you be doing as Quality Director?

•    Development, implementation and support of the Company's quality control and assurance systems in accordance with the current legislation of the Russian Federation and requirements of Octapharma group of companies.
•    Effective management of the Quality Management Division and its sub-departments.
•    Coordination and control of all works directly and indirectly related to quality assurance and quality control of raw materials, production processes and facilities, and manufactured products.
•    Together with the General Director and in accordance with Quality Policy of LLC ‘Octapharma-FARMIMEX’ and Octapharma group take an active part in implementation and support of Quality Management System at the Company, through its development and improvement.
•    Assure the production and release of products that are safe and efficacious and comply with all requirements and specifications for the product and its manufacture.
•    Responsibility for the approval or rejection of starting and packaging materials, intermediate products and finished products.
•    Responsibility for establishing procedures for the control and release of products to the market.
•    Control of Good Manufacturing Practice (GMP) training of the Company's personnel according to SOPs and initial training programs for newly hired Employees.
•    Responsibility to control that all calibration, qualification and validation requirements for the facility, processes, equipment, and laboratories are complied with.
•    Participate in the development of the program of validation and revalidation of production processes.
•    Development of internal audit and self-inspection programs at the enterprise, ensuring their implementation, review and documentation.
•    Approval of specifications, SOPs, testing methodology, manufacturing procedures and other control instructions used in the facility.
•    Supervising contractors carrying out work for Quality Management Division.
•    Supervising the maintenance of the Quality Management Division, its facilities and equipment.
•    Performance of an annual product review for all products. Report to management on KPIs related to product qualities, number of deviations, and potential problem areas.
•    Participation in selection and approval of suppliers of incoming materials and the control over them.
•    Implementation of a continuous Quality improvement program.
•    Carrying out inspections, investigations and sampling to identify factors that may affect product quality, resolve deviations, propose CAPA, and monitor that the CAPA has been implemented. 
•    Responsibility for the final decision on acceptance of finished products or their rejection.
•    Responsiility for the decision on initiating a product recall. Assurance of the traceability of all raw materials to the final products, and the reverse.
•    Participation in submission of claims to suppliers for the review of product quality claims and their elimination.
•    Optimal staffing of the Quality Management Division. Participation in the preparation of job descriptions, recruitment, and induction of Quality Management Division personnel. Responsible for the establishment of training programs and evaluation techniques for the qualification of personnel to perform operations within the. Performance evaluations of personnel in the structural unit, disciplinary actions against Employees when required, and the general health and safety of all Employees in the Quality Management Division.

Who are you?

•    Education: higher education, (pharmaceutical, chemical-pharmaceutical, chemical-technological, chemical, medical or biological).
•    At least 5 years' experience as Quality Director, Head of Quality Assurance/Quality Control for pharmaceutical manufacturing.
•    Fluent in English.
•    Ability to work in Word, Excel, PowerPoint, MS Project.
•    Ability to work independently and as a team.
•    Knowledge of legal requirements and regulatory acts that regulate manufacturing and quality control of pharmaceutical products. 
•    Knowledge of regulations and norms of Russian and EU GMP standards.
•    Ability to work with confidential information.

What's the best thing about working with us?

•    You help save lives - Every day is meaningful as we produce life-saving medicines
•    Family values - Long-term perspective for employees and relationships 
•    Be rewarded with an attractive salary and benefits package
•    You will be a part of the unique project 
•    You will have a high level of influence where you can make a difference and leave your footprint
•    Work with skilled and fun colleagues in a relatively informal organization
•    Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions

Apply Today!

If you have questions about the position, contact Ms. Anastasiya Tsygankova, HR Director, email: anastasiya.tsygankova@octapharma.com or Irina Merkulova, Senior HR Generalist, email: irina.merkulova@octapharma.com
If you proceed in the process

•    We will endeavor to review your profile as quickly as possible and provide you with feedback
•    The next step is to conduct a interview, which takes about 30 minutes.

Would you like to get to know us better? Learn more about us on our website!