• Home
  • Jobs
  • Quality Product Project Support Specialist

Quality Product Project Support Specialist

Temporary - BRAINE-L'ALLEUD - Quality Management in Pharma & Life Sciences

Quality Assurance expert, with project management experience

Apply now

  • Quality Assurance
  • GMP
  • Project Management

What you'll do

Nature of scope:

This position will provide leadership and QA expertise in product related project activities concerning products that are externally manufactured.

Be part of a proactive, solution oriented operational QA team and projects teams that will drive quality related project activities for lifecycle management of Vendors (Contract Manufacturing Organizations) and the associate Products portfolio.

This position will provide Quality support to projects in relation to

  • Manufacturing process review and process improvement
  • Process and method transfers between manufacturing sites and analytical laboratories
  • Regulatory submissions as above
  • Product Quality Reviews
  • Validation Protocols and Qualification Reports
  • Product Launches
  • Quality Processes
  • Mapping of Quality related product and manufacturing supply chain
  • Product cockpit

Major Accountabilities:

  • Provide support to the Global (Product) Quality Leads with respect to Quality support on e.g.,
    - Review of changes to Manufacturing process
    - Regulatory submissions
    - Product Quality Reviews
    - Change controls
    - Product complaints
    - Validation Protocols and Qualification Reports
    - Product stability program
    - Quality risk mitigation activities
    - Definition and improvement of Quality processes
    - Quality Agreements
    - Process and method transfers between manufacturing sites and analytical laboratories
    - Product launches
    - Mapping of Quality related product and manufacturing supply chain
    - Product cockpit
  • Drive above quality related project activities in accordance with overall project plan. Escalate any delays or constraints to project leader
  • Provide Quality expertise in the review and approval of project related technical, analytical, and quality documents 
  • Be responsible for oversight and tracking of quality related project activities 
  • Prepare and write Quality documents, investigations, and reports in support of above activities as required
  • Provide Quality support to the regulatory submission process to the extent where modifications are required to approved manufacturing processes, analytical methods, specifications, or other methodologies
  • Work closely with Global QA teams, Technical Operation Teams, Business stakeholders and Contract Manufacturers in an effective and efficient way
  • Work in accordance with HSE and Corporate policy requirements

Who we're looking for

Profile:

  • 4-8 years working in the pharmaceutical/biologics industry with a profound knowledge and understanding of Quality management and operational GMP experience
  • Experience and knowledge about European Good Manufacturing Practices
  • Experience interacting with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparedness.
  • Auditing expertise is a plus.
  • Eligibility as a Qualified Person in EU would be an advantage
  • Bachelor or Master degree

Specific skills:

  • Good pharmaceutical technical understanding and expertise enabling to review and judge upon technical documents related to manufacturing and analytical testing
  • A QA critical mind set on reviewing documents
  • Fluent and confident use of English language verbally and in writing
  • Good knowledge of reading & understanding of French is a plus as some documents may be written in French
  • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
  • Ability to work autonomously for the assigned project activities with limited oversight by a leader
  • Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
  • Must be skilled and experienced in operating across cultures and in a multi-cultural environment
  • Project management experience is nice to have

Problem solving:

  • Must have the ability to independently analyse data and information to draw conclusions and make effective decisions.
  • Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way
  • Must be able to develop innovative solutions through judgment and reasoning leveraged from quality experience.

What you'll get

Our Pharma & Life Sciences department is growing. We offer you the opportunity to join our dynamic team of consultants, work on projects that will challenge you, and that will push you towards the next step of your career.

Do you have what it takes? Apply now.

By phone, we can contact you faster.

Choose file No file selected

Add CV as text