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QA Change Control Project Manager
Тип контракта
Полный рабочий день
Опыт работы в фармацевтической области
От 3 до 6 лет

МОСКВА

QA Change Control Project Manager

Опубликовано: 06 Сен 2021

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Purpose & Scope:

Project manages and executes tasks associated with the Change Control quality system following management guidance and oversight. Maintains & monitors the applicable change control system, associated databases to ensure that records are in a compliant state and generates metrics for routine reporting. Assures Astellas compliance with global regulations, corporate standards and SOPs for Change Control and general quality systems. Supports additional Quality Assurance initiatives as requested.

Essential Job Responsibilities:

  • Executes tasks associated with all Astellas’ quality systems as directed, with a focus on change control, as an individual contributor and updates related databases and/or tracking tools in a timely manner. Generates status reports as required and maintains relevant change control databases and/or project management plans.
  • Is a subject matter expert (SME) for the global change control system and interfaces with local affiliate QA functions to integrate local change control activity with governing corporate change control(s). Acts a resource for affiliate QA with respect to change control system.
  • Project Management of complex multi-faceted strategic change controls as it relates to business objectives and assurance of change control implementation for all globally impacted stakeholders.
  • Initiates, evaluates, assesses and tracks change controls utilizing effective project management skills and tools to monitor global action items / deliverables to target due dates. Ensures compliant and timely implementation of changes.
  • Utilizes technical skills and quality assurance experience to identify areas of concern in both electronic and paper-based change control quality systems, as well as specific project deliverables. Evaluates and assesses risks to facilitate timely notification to management and provides proposals for resolution.
  • Coordinates the collection and tabulation of metrics related to the change control quality system as directed by management. Monitors system for positive and adverse trends.
  • Assures global Astellas adherence and compliance with corporate policies, SOPs and global regulatory standards. Identifies issues and initiates corrective and/or preventive actions as required.
  • Supports any additional quality activities related to the performance of gap assessments and/or resolution of any identified risks as requested.
  • Effectively communicates with departmental and global cross-functional teams to support and facilitate change control project deliverables.
  • Responsible for the storage and maintenance of quality-controlled documentation related to change control activity.

Quantitative Dimensions:

Executes tasks associated with general quality systems, and more specifically, the Astellas global change control quality system. Project manages any assigned change control related activity and deliverables to completion in partnership with global Astellas quality assurance affiliates and external business partners as applicable. Assists, develops and manages timelines to maintain compliance to Astellas project timelines, SOPs, standards and global regulatory requirements.

Organizational Context:

This role reports to the QA Commercial Quality Representative of Russia as applicable. Works closely with other areas such as Regulatory Affairs, PV, Legal, Commercial, Supply Chain, Market Access, Global Project Management and Product and Project Management.

Qualifications:

Required:

  • Minimum BA/BS with minimum 5 years of industry experience with a minimum of 3 years QA / QC experience and 2 years of project management.
  • Knowledge of global GMPs and other industry regulations
  • Strong, effective communication and interpersonal skills with an emphasis on cultural awareness.
  • Ethical, results-oriented professional with attention to detail.
  • Individual contributor with understanding and commitment to team success and efficiently executes assigned tasks per management direction.
  • Confident & professional representation of Astellas to external stakeholders including international health care professionals.
  • Requires strong project management skills and ability to execute change control responsibilities.
  • Strong technical writing skills, English.

Preferred:

  • Proficient in TrackWise;
  • Commercial affiliate experience.

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