Senior Quality Assurance Associate

Уровень зарплаты
Город
Требуемый опыт работы
з/п не указана
Москва
1–3 года

Large foreign medical company is looking for Senior Quality Assurance Associate

The position is accountable for the oversight and execution of Quality Management Systems and compliance at CLS (internal and/or 3PL) within the corresponding country that receive, pick, pack, store, inspect, repack/relabel and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors

Responsibilities:

Distribution and Inventory Management Processes

  • Responsible for execution and overseeing the controls and quality standards for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation)
  • Responsible for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting the Distribution Centers
  • Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations

Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring)

  • Accountable for defining and implementing requirements for physical product testing (e.g. functional testing, visual inspection & verification) occurring in the Distribution Centers (DC) or outsourced by the DCs
  • Responsible for defining, designing and implementing requirements for repackaging and relabeling operations to be conducted within the Distribution Center to assess repackaging and relabeling requests and collaborate with business partners to meet pre-defined requirements
  • Accountable for adherence to temperature control and monitoring requirements within the facilities

Quality Management Systems

  • Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues
  • Responsible for overseeing the controls and quality standards for Quality Systems validation, including WMS, CAPA, NC, Internal Audits, Document Management software systems
  • Compliance
  • Execution of Distribution Center Management Reviews
  • Responsible for the successful management of all Health Authority inspections (e.g., Roszdravnadzor, Rospotrebnadzor etc.)
  • Responsible for the proactive identification and mitigation of compliance risk at the DCs through metrics reporting, internal audits, and other compliance programs

Distribution Supplier Quality Management

  • Supports for establishing Quality Agreements with, qualifying of, and Q&C management of distribution, logistics, and material suppliers (excluding Distributors)

Requirements:

  • Experience in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business;
  • Knowledge of GMP and GDP preferred;
  • It is preferred that the job holder is an experienced internal auditor or certifies lead auditor;
  • English on intermediate / upper-intermediate level as a must.

Тип занятости

Полная занятость, полный день
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