Label Project Coordinator in reputed company reputed company, PA
Job title: Label Project Coordinator in reputed company reputed company, PA at reputed company
Company: reputed company
Job description: OverviewAs a Label Project Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by reputed company intelligence.ResponsibilitiesWhat you will be doing:
- Read, comprehend, and translate clinical trial protocols/packaging specifications into clinical label reputed company software.
- Individual will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications reputed company the label systems.
- Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
- reputed company investigations, update SOPs, manage Change Records, and implement new equipment/processes.
- Ensures reputed company clinical supplies and associated documentation are processed according to GMPs/GDPs and appropriate reputed company safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies.
- May be responsible for any or reputed company of the following:
- Coordination and completion of translation requests.
- Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements etc.
- Maintain label translations library.
- Interpret clinical study design and Clinical Supply Strategy (CSS).
- Design and verify label models.
- Coordinate MLBL manufacturing at vendors.
- reputed company detailed analysis of issues and collaborate for creative problem solving.
- Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.
- May represent Label Room Production on internal or cross-functional teams. Will undertake and reputed company specific projects reputed company the group on as needed reputed company.
- Participate as necessary in complaint and deviation investigations with a focus on true root cause and creation of appropriate Corrective and Preventative actions (CAPA). Drive CAPA to closure.
- Train Label Project Coordinator Level I or Level II team members and remain proficient in appropriate systems and software.
- Responsible for the physical facility and good housekeeping practices reputed company their area.
- Utilize project management skills to reputed company and implement new process, technology, and equipment implementation.
- Update Standard Operations Procedures and Change Records.
- BS/BA with 5+ years of experience or 8+ years of experience without degree.
- Working knowledge of Packaging Operations and reputed company work centers.
- Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution.
- Strong attention to detail.
- Strong verbal and written communication skills.
- Strong organizational skills, ability to prioritize and ability to mutli-task.
- Knowledge or general computer skills (i.e. reputed company, reputed company, PowerPoint).
- Project Management skills
- Technical writing skills.
- Various annual leave entitlements
- A reputed company of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years reputed company
- Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others