Quality Unit Lead

з/п не указана

Требуемый опыт работы: более 6 лет

Полная занятость, полный день

A competition for the Quality Unit Lead position is open in a foreign biopharmaceutical company

Responsibilities:

  • Ensuring that a Quality Management System is implemented and maintained including the local market:
  • Acting as the local Qualified Person responsible for GMP & GDP in accordance with Market regulatory requirements
  • Responsible for GMP activities for certification of Manufacturing sites
  • Being a conduit between local Health Authority and/or Trade and Industry Association and the corresponding Company Global functions for GMP documentation coordination, GMP applications and filing
  • Attending Health Authority inspections of Manufacturing sites as the In-market quality subject matter expert
  • Facilitating the CAPA responses
  • Ownership of implementation of new GMP/GDP Eurasian requirements
  • Maintaining Quality System Documentation: procedures and records
  • Company Policy/Directives/SOPs impact assessment and implementation
  • GDP and Local regulations impact assessment and implementation
  • Meeting the requirements of the defined Quality Unit activities
  • Ensuring initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified
  • Developing and maintaining locally the Quality Manual
  • Ensuring that relevant customer complaints are dealt with effectively
  • Performing periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures
  • Ensuring implementation of Deviation and CAPA management
  • Ensuring implementation of the Change Control management
  • Reviewing the APQRs, as required per local regulations
  • Leading the Quality Management Review/Quality Council of the Market
  • Reporting quality metrics and implements adequate action plans for metrics achievement when necessary
  • Participation in periodic local Senior Management / Leadership team review meetings
  • Ensuring implementation of following Quality Operations:
  • Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
  • Customers oversight: periodic customer License verification
  • Production Quality status and batch release or approval to the market
  • Local QC testing, CoA review and local release, when applicable
  • Analytical transfer coordination/approval to meet product launch, when applicable
  • Handling compliance/quality issues with the impacted market team
  • Attending the Market Action meetings when required and defines the adequate action plans within market
  • Ensuring On Hold products request are observed
  • Coordinating and promptly performing any market action operation, recall, for medicinal products. Mock recalls
  • Deciding on the final disposition of rejected, recalled or falsified products
  • Approval of the returns to saleable stock, according to Company requirements
  • Support Supply Chain to avoid Back Orders
  • Providing quality input on shortage situations and oversight reporting to Health Authority
  • Medical samples Quality distribution oversight
  • Supporting of sampling requested by HA (product, procedures, reference substances)
  • Keeping appropriate records of any delegated duties
  • Facilitating that Company requirements are implemented in the Local Distribution Centre for:
  • Warehousing facilities
  • Secondary packaging facilities
  • Transportation processes
  • Quality Risk Management:
  • Coordination and preparation of Quality Risk Management
  • Participate in the periodic Business Review with the DC
  • Inspections and Regulatory Surveillance:
  • Maintenance of the Wholesale Distributor License with Regulatory agency
  • Import certificates, when requested
  • Support the Global Quality Audits in the market
  • Preparation of HA inspection in local entity and leading HA inspection
  • Anticipation the new directives (Regulatory surveillance) and proactively drive change


Requirements:

  • Minimum Bachelor of Science (preferably - pharmaceutical, biological, chemical or similar)
  • Experience within the quality function of the pharmaceutical health care industry or with regulatory agencies
  • Experience in Quality Operations
  • Manufacturing facility experience, Proficient in GMPs
  • Experience working with Health authorities
  • Managerial and Operational skillset
  • Experience in biological products, commercial products, sterile products, Distribution practice, Batch release
  • People management skills
  • High communication and interaction skills, familiar with local culture
  • Good verbal, written and presentation skills in English

Ключевые навыки

Английский — C1 — Продвинутый
Team management
Leadership Skills
GMP (Good Manufacturing Practice)
GDP
QP
Quality Management

Вакансия опубликована 8 ноября 2020 в Москве

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