Quality Assurance Manager, Commercial Quality

Job Description

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Job Description

OBJECTIVES/PURPOSE:

The Quality Assurance Manager supports the effective operations of the local quality management system in accordance with corporate standards, international and Russian laws.

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).

Implementing scheduled changes in the QMS processes through the development, and approval of documents/local SOPs and the adoption of applicable Global SOPs as applicable.

Leading the complaint management at LOC level; Organization of maintenance, proper operation of the external audit system; Preparation, organization and execution of audits of suppliers and wholesalers including the preparation of reports, development of CAPA plan and tracking CAPAs completions
Timely development and completion of quality agreements with suppliers, wholesalers, transport companies, etc., including tracking the status; Supporting the execution of local batch releases and the management of associated deviations, CAPA, etc.

CORE ELEMENTS RELATED TO THIS ROLE: Supplier Quality management, Complaint management, Change Control management, Local Product Releases

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 holding audits and inspections (internal, external, including service providers).

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

Decision-making and Autonomy make decisions in his/her area of responsibility; 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.

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; 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 5 years. Advanced level English, including knowledge of specialized terminology. Solid knowledge of EAEU GMP, GDP, requirements to the Quality Management Standards.

More thab 3 years of Experience leading 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 Quality Assurance Manager shall 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)

Locations

Worker Type

Worker Sub-Type

Time Type