Product Quality Lead

Компания "АстраЗенека"

Job Duties

- Ensure Compliance with Russian legal requirements and principal of GDP quality system according to applicable normative- legal acts and Company’s policy and standards;

- Ensure compliance to gain and maintain GDP license;

- Ensure implementation and maintenance of a GMP/GDP quality management system;

- Participate in defining the strategy for the commercial global markets ownership and execution of Affiliate GMP and GDP Quality System and framework

- Accountable for Quality Management Review process, preparation and execution and escalations;

- Contribute to preparation of Quality Review reporting Alexion RU Leadership and routine Board of Directors Compliance committee related to Market Quality performance;

- Represent Product Quality on cross-functional teams and committees;

- Drive global standardization, simplification and improvement of Product Quality processes in innovative delivery of results.

- Planning, review and manage budgets for the Product Quality

- Ensure the implementation and maintenance of initial and further training programs for the entire personnel involved in the distribution process;

- Ensure efficient work with buyers’ (recipients’) claims;

- Approve outsourcing of the activities that potentially affect the compliance with good distribution practice;

- Ensure the conduction of self-inspections with an established frequency and prepared programme and to ensure taking any necessary corrective measures;

- Making decisions regarding returned, recalled, rejected, recognized to be of poor quality and falsified medicinal products;

- Approve the return of medicinal products to the category of drugs suitable for sale;

- Ensure compliance with any additional requirements established for certain products by the applicable laws of the Member States;

- Ensure compliance and efficiency of the GDP QS. To ensure provide GDP QS review from General manager. Implementation of the improvement system in the GDP QS area;

- Performance of the duties of the Responsible person of the Company (Confirmation of quality compliance and release into the civil circulation medicinal products, that the AstraZeneca LP, imported into the territory of the Russian Federation);

- Updating and approving the GDP QA documentation (Police and Purpose, Guidelines, SOPs, Reports, Instructions, Plans/Programms);

- Implementation and Maintenance of the Deviation and Issue management in the GDP QS area;

- Ensure of the CAPA management in the GDP QS area (preparation of the CAPA-plan, approving and CAPA-status monitoring);

- Ensure and coordinate of the Change-management system in the GDP QS area;

- Assurance providing of the GDP QMS review by General manager

- Leads preparation, conduct and follow up of a Regulatory Authority inspection in according to the applicable Internal standards of Company;

- Ensuring timely preparation and maintenance of Quality agreements;

- Ensure local process of pharmacovigilance process continuity

- Ensure compliance to the requirements of the quality system of pharmacovigilance of the Company (quality control, self-evaluation, self-inspection, audit interviews of the providers) .

- Participation in Validation and Qualification of GxP Computerised system;

- Transportation company assessment and audits;

- Participation in the qualification of thermocontainers, route risk assessments, qualification of vehicle.

Requirements

• 5+ years experience
• University degree of Pharmacy/Medicine/Chemistry
• Managing a cross functional team
• Outstanding leadership and partnering competences
• Self-motivated and independent
• Ability to meet deadlines under pressure
• Critical & systems thinking and risks management skills
• Excellent communication skills (verbal and written)
• Fluent in written and spoken English
• Strong organization/planning skills and ability to manage multiple concurrent projects