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Quality Assurance Leader, LS, RCIS

  • GE Healthcare
  • Experienced
  • Posted 11/2/2017 3:49:06 AM
  • 3016257
  • Job Function: Quality
  • Business Segment: Healthcare Quality
Location(s): Russian Federation; Moscow

About Us:
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

Role Summary:
Employee in this position acts as the Quality Assurance Leader & Head of Warehouse Life Sciences.

Essential Responsibilities:
he Quality Assurance Leader ensures product and process compliance to regulatory requirements for the designated product line(s) by managing the quality system design, controls and continuous improvement and establishing best practice standards in post-market support of products. This person will provide advice & counsel to business managers and Quality & Regulatory personnel within RCIS. The Head of Warehouse controls all internal operations and activities at the warehouse. The Head of Warehouse controls all internal operations and activities at the warehouse. The Head of Warehouse manages all the required documentations and ensures that they are up to date.
Employee in this role has below responsibilities:
• Participate in the development and maintenance of a best in class Quality Management System (QMS) and relevant processes to assure product quality and safety.
• Coach and mentor functional teams on the development, maintenance and simplification of local procedures.
• As appropriate, recruit, mentor, coach & train indirect reports, as well as distributors on activities within areas of responsibility.
• Ensuring accuracy, scientific validity and optimal presentation of submission documents that meet current best practice standards.
• Effectively assisting or planning submissions and regulatory documents to agreed timelines and ensuring alignment with agreed strategy.
• Providing regulatory advice to teams on assigned projects.
• Identifying regulatory issues and resolving them with relevant departments or country offices.
• Communicating with Regulatory Authorities and contractors to expedite review and approval of submissions.
• Safekeeping of documents archive in coherent order.
• Ensuring compliance of label creation process (AMS) with local regulations.
• Dealing with internal GE workflow.
• Working with customer complaints; cancelling the product (if it’s in your competency)
• Providing warehouse staff members with informational updates, professional documents, orders, etc.
• Ensuring the availability and correctness of distributors’ licenses and documents (on a yearly basis)
• Managing warehouse documentation
• Preparing documents and warehouse spaces for licensing
• Conducting supplier and internal audits
• Hosting regulatory inspections and ensure inspection readiness

• Bachelor’s Degree in Pharmacy & valid pharmacy certificate
• At least 5 years of work experience
• Proficient use of MS Office
• Knowledge of Quality Management Systems (QMS) and Good Distribution Practices (GDP)
• Fluent in English and Russian

Desired Characteristics:
• Ability to work across cultures
• Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
• Team-oriented and responsive to customer needs.
• Familiar with continuous improvement methodologies such as Lean & Six Sigma
• Ability to independently resolve straightforward issues and identify proposed strategy for complex issues
• Demonstrate good interpersonal skills required to build relationships with and influence internal departments, country offices and externally with Regulatory Authorities•

Locations: Russian Federation; Moscow

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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