Senior Quality Assurance Specialist

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OBJECTIVES/PURPOSE:

• LOC senior Quality specialist is responsible for the in-country batch release to ensure compliance of imported medicinal products with the local regulatory requirements in Russia.
• Lead the annual full testing implementation in accordance with the local regulations in Russia
• Execute the investigation of deviations, change controls, CAPA management, etc. associated with batch release/disposition process.

SCOPE: 

Financial:

Est. annual revenue range of accountability*:

O

Est. annual budget of responsibility:

n

Leadership/People:

No. of direct reports: 0

No. of indirect reports: 0

Geographic Scope:

Global: _____

Regional: ______

Countries

Russia

*if applicable

ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job.  Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).

Testing medicinal product batches for compliance with quality standards in accredited laboratories per Russian laws. Confirming compliance of the imported medicinal product with the requirements established during its state registration:

• assessment of conditions of the product transportation and storage.
• assessment of compliance of actual parameters specified in the product quality passport (quality certificate) with the specification parameters approved during registration of the medicinal product in the Russian Federation.
• organization and control of sampling medicinal products for assessment of compliance of products received with the specification parameters.
• execution and publication confirmations of the medicinal product batch compliance with the quality requirements established during its registration, on the website of Roszdravnadzor (Federal Service for Surveillance in Healthcare) before putting the batch into civil circulation.
• execution of other documents and notifications in authorized organizations (public and commercial) about putting a batch or lot into circulation in the Russian market.

Assessment of data about deviations and scheduled changes in manufacture and (or) quality control in relation to the quality of the medicinal product released, including:

- initiation of CAPA plan for any deviations relating to product quality parameters.

- assessment of medicinal product batch dossier and annual quality review as needed.

Supporting efficient management of Product Quality complaints. Organizing audit of service providers within the area of his (her) responsibility (i.e laboratories, reagent's suppliers). Participation in the medicine recall process.

Performing individual tasks and assignments issued by the line manager during the working process.

CORE ELEMENTS RELATED TO THIS ROLE: Russian local release requirements implementation for each imported batch

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

Solid knowledge of EAEU GMP, GDP, requirements to the Quality Management Standards Knowledge of requirements of 61st Federal Law about medicine's circulation. Knowledge of requirements of international standards and recommendations on GMP quality processes (WHO, PIC/S, FDA). ISO 9000 standards. Experience of performing audits and inspections (internal, external, including service providers).

Leadership Cross-functional collaboration, communication, influencing others, priorities' setting

Decision-making and Autonomy act as RP (responsible person) assigned by the LOC GM order, taking decision for product release, recall, batch disposition

Interaction: LOC cross-functional interactions; building and supporting stable reliable relations with key units of the Company at the local and global level. Close collaboration with external 3rd parties and governmental laboratories

Innovation Understanding of local industry, scientific and regulatory trends, and its market conditions and requirements.

Complexity Release of governmental tender's portfolio, readiness to be involved for support of BIO manufacturing part from QA perspective of; work in cross-cultural team

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

Higher education in chemistry/chemistry and technology/chemistry and pharmacy/biology/biology and technology/microbiology/pharmacy.Experience of work in QA/QC more than 3 years. Advanced level English, including knowledge of specialized terminology. Solid knowledge of EAEU GMP, GDP, requirements to the Quality Management Standards. Experience of participation in audits (internal, external, including service providers). Proficiency in English – Spoken and written   

Core Competencies / Skills

• Critical Thinking
• Investigation and problem solving
• Strong communication and stakeholder management skills
• Ability to influence and work effectively with local cross-functional team
• Agility and ability to manage complexity & balance priorities
• Risk identification, evaluation, and management.

Leadership Behaviors

• Enhanced enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Creating an environment that inspires and enables people.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.

ADDITIONAL INFORMATION:

The Senior Quality specialist shall comply with RF laws, Company's procedures and policies, compliance requirements, business ethical principles and business conduct rules.

 He/she shall also act in accordance with the Labour Code of the Russian Federation, Internal Work Regulations, this Job Description, industrial safety standards, occupational safety rules, and other local regulations. 

Potential Domestic travel: rarely

Physical Demands: preferably from Moscow region

Working Environment: 80/20 (onsite/remote accordingly)