נישה – השמה איכותית בתחומי הייטק, ביומד ופיננסים
 

QA קליני

משרה מס': 397146

תיאור המשרה:

 

Supports E2E project activity by providing quality process requirement and technical support.

Support quality systems issues (CAPA’s, Non-Conformances and changes) related to Facility, systems, equipment, laboratory, existing processes and developments of new processes.

Generate and review completeness of documents, involve in preparation of annual review and participate in quality investigation.

Participate in audits for good manufacturing practices, international organization for standardization and any other applicable standards.

The scope of this position includes all related to both biologics and device.

  • Establish new processes related to clinical batches manufacturing and release.
  • Defining control points and quality standards for new products.
  • Reviews processes, including both quality and production processes. Identifying critical to quality steps and estimating process capability, where applicable.
  • Using structured techniques to determine failure modes associated with a process, determine the cause of variation, and implement improvements.
  • Uses problem solving technique to support manufacturing via ownership of process related NCRs, and CAPAs.
  • Evaluating non-conformances, leading or participating in root cause investigations, approving disposition plan.
  • Leading or participating in risk assessments processes and product disposition.
  • Designing experiments and test plans for root cause investigation, continuous improvement or validation.
  • Creating and Evaluating Change Requests; Reviewing proposals for change to production methods and test methods.
  • Reviewing and approving other departments documentation related to the project
  • Handles batch release
  • Handles product complaints, dose audits, purchase demands
  • Participating in task force teams introducing new products/processes to the facility.
  • Support internal and external audits
  • Performs routine tracking and trending of process parameters and suggests improvements to ensure adequate process capability to produce quality products in required quantities at an effective cost.
  • Acquires process end to end view and works with associates from other functions as well as external suppliers and internal customers from the site or from other sites.
  • Participates in design change projects in collaboration with all functions and the R&D organization associated to products and process already in production.
  • Utilizes industry and process excellence standards in routine quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO)
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed


דרישות התפקיד:
  • University/bachelor's degree or Equivalent (B. science is preferred)
  • Requires 2-3 Years Work Experience in the quality (pharma industry is preferred)
  • Experience in the Medical Device industry or medical field
  • Experience in clinical trails
  • Demonstrated knowledge of manufacturing principles and practices
  • Knowledge of specific business practices and software applications
  • Ability to work cooperatively with coworkers
  • Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements


שתף:

חיפושים קשורים:
לחברת תרופות וציוד רפואי דרוש/ה איש/ת מכירות לבתי מרקחת לחברת פארמה מובילה דרוש/ה אונקולוג/ית קליני/ת מנהל/ת פיתוח תהליך יצור מוצר סטרילי פרמצבטי אצל קבלן משנה בחו"ל. הנדסאי/ת לעבודה בחדר נקי
 
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