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Global Quality Compliance Specialist

Company: Astrix Technology Group
Location: Dayton
Posted on: January 12, 2021

Job Description:

JOB SUMMARY This position will play an important role in creating and maintaining a Global Quality System for all sites through the implementation of global procedures and policies. Furthermore the Global Quality Compliance Specialist will share the Global Compliance Group responsibility to ensure the quality and safety of products through an intense qualification program of our suppliers of critical materials and services. Job Requirements:* ESSENTIAL DUTIES AND RESPONSIBILITIESThe primary duties and responsibilities of this position include the following. Other duties may be assigned.-- Manages the Global Documentation writing, approving and issuing global SOPs, policies and related documents ensuring that training is carried out at Adare sites when needed-- Manages the Quality Agreements with suppliers of critical materials and GXP-related services-- Plays an active role in the risk management of starting materials and suppliers as per company procedures and policies-- Manages the supplier-related software and supplier databases-- Performs the annual assessment of suppliers and writes the supplier status certificates-- Participates in the Global Compliance audits of--sites and follows the implementation of the proper CAPA to ensure compliance with the current regulations and internal policies-- Occasionally participates in the suppliers audits with the aim to obtain the auditor qualification, writes the relevant audit reports and keeps the suppliers' CAPA monitored to ensure compliance with the applicable regulations-- Ensure that Management is informed of critical findings resulted from internal and suppliers audits-- Supports the local Quality Units when major and critical issues occur with the suppliers of materials and GXP-related services-- Supports the local Quality Units in the preparation of inspections from the Health Authorities and provides the necessary information to answer question related to the supplier management or to prepare a response to written communications-- Carries out his/her--job in compliance with the company policies/procedures and law directives concerning safety and GMPs.-- Attends work on a regular and predictable basis.-- Completes assigned tasks in a safe manner and in a constant state of alertness.-- Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.-- Works in a cooperative--manner with managers, supervisors, coworkers, customers and the public.-- Works effectively under deadlines.SUPERVISORY RESPONSIBILITYNoneEDUCATION AND/OR EXPERIENCE-- Bachelors or Masters Degree in Chemistry, Pharmacy, Biology, or Biotechnology Science-- 5+ years of professional experience in a Quality Control/Quality Assurance department-- Good knowledge of GMP rules regulating production of the drugs and medical devicesQUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.-- Excellent interpersonal written and oral communication skills-- Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, Vlookup, Macros, If Statements, Formulas).-- Ability to coordinate, contribute to and work within a cross-functional team.-- Ability to thrive in a dynamic and fast-paced environment.-- Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.-- Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.-- Exceptional attention to detail and excellent organizational skills.

Keywords: Astrix Technology Group, Dayton , Global Quality Compliance Specialist, Other , Dayton, Ohio

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