Quality Assurance Manager

Career
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Job description

  • Ensure compliance, continuous improvement, support, maintenance, and regular evaluation of the Quality System.
  • Provide support for projects and report on key performance indicators (KPIs) and key quality indicators (KQIs).
  • Develop and implement a Quality strategy for the site to ensure compliance with GMP requirements (WHO GMP, EU GMP, PIC/S).
  • Oversee the process of certification and product release to the market.
  • Organize, implement, and enhance the Pharmaceutical Quality System while monitoring and assessing its performance at Davipharm.
  • Initiate and coordinate corrective and preventive actions (CAPA), manage deviations and complaints, and supervise CAPA activities to eliminate negative events.
  • Establish key quality indicators to drive process improvements and ensure their implementation.
  • Implement and promote the use of problem-solving tools.
  • Supervise the preparation and execution of internal and external audits, assessing the effectiveness of the quality system in audited units.
  • Coordinate activities to ensure compliance with GMP requirements.
  • Lead and manage the Compliance Quality Project as a Project Leader/Manager.
  • Oversee quality-related projects at Davipharm.
  • Manage the team to achieve business objectives, drive team development, set priorities, and oversee recruitment.
  • Handle product returns and coordinate product recalls.
  • Manage inspections at Davipharm.
  • Represent the Quality function in business meetings.
  • Identify, recruit, and develop qualified personnel for the QA department.
  • Focus on people development and supervise the QA team.
  • Hold decision-making authority regarding the release or rejection of finished product batches.
  • Approve supplier complaint decisions.

Job requirement

  • Pharmacist qualification.
  • At least 5 years of experience in a managerial or expert role within the Quality Unit.
  • Ability to work under high pressure and meet strict deadlines.
  • Strong knowledge of WHO GMP, EU GMP, EMEA, PIC/S, and lean management in the pharmaceutical industry.
  • Excellent written and verbal communication skills.
  • Strong ability to manage high-stress situations.
  • Ability to multi-task and manage multiple project elements simultaneously.
  • Leadership skills.
  • Big-picture thinking and strong vision.
  • Conflict resolution skills.
  • Proficiency in MS Office 365 (Excel, Word, AutoCAD).
  • Excellent command of English.

Please contact our Recruiter or apply via email recruitment@davipharm.info