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Regulatory Affairs Specialist
İş Tanımı

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Genel Nitelikler

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Purchasing Specialist
İş Tanımı

RESPONSIBILITIES & DUTIES

  • Identify and secure reliable sources of quality goods from foreign and local suppliers, negotiating pricing, payment terms, and delivery cycles to meet the needs of the organization
  • Assess foreign suppliers of goods, analysing performance and satisfaction in terms of pricing, supply, delivery, and quality
  • Work closely with the regulation department to ensure contract terms are favourable to the company
  • Develop and maintains relationships with prospective suppliers by discussing price, product quality, and delivery cycles
  • Verify business and financial references of prospective suppliers
  • Recommend potential suppliers to appropriate staff
  • Coordinate trial orders with new suppliers
  • Coordinate and expedite import process
  • Oversee delivery dates, quality of production, and sufficiency of product
  • Negotiate terms of payments with suppliers
  • Identify and implement preferred payment methods
  • Maintain current knowledge of external factors that could affect availability of goods and pricing; examples include applicable import regulations, taxes, tariffs, and political and economic situations in the countries of origin
  • Review existing contracts with suppliers and vendors to ensure on-going feasibility
  • Build and maintain long-term relationships with vendors and suppliers
  • Perform other related duties as assigned
  • Report to General Manager
Genel Nitelikler

SKILLS & COMPETENCIES

  • Being familiar with the company’s supply process
  • Strong understanding of procurement and negotiation techniques
  • Excellent verbal and written communication skills
  • Strong negotiation and conflict resolution skills
  • Able to travel to meet with suppliers and work overtime as required
  • Fluency in English (speak, read and write)
  • Have good knowledge of Microsoft Office
  • Have an outstanding communication skill, both verbally and in written form
  • Have excellent organizational and planning skill for proper running of an organization
  • Be ambitious, have strong work ethic, and a willingness to learn
  • Be a fast learner with strong problem-solving skills * Positive & winning attitude
  • Ability to understand and effectively communicate at all management levels, technical dependencies, timeline impact and risks
  • Good attention to detail
  • Highly organized and detail oriented 

SUPERVISORY RESPONSIBILITIES                                       

No                                                                                                          

WORKING ENVIRONMENT

Office work environment. Regional travel 20%

REQUIREMENTS

  • Bachelor’s degree in engineering, supply chain management, logistics, business administration or related fields
  • In-depth knowledge of preparing and reviewing contracts, invoicing, and negotiation terms in foreign trade
  • Basic understanding of the types of goods to be purchased
Quality Control Specialist
İş Tanımı

RESPONSIBILITIES & DUTIES

  • Implement and maintain quality control system in accordance with applicable regulatory requirements
  • Manage, initiate, and participate in resolution of customer complaints and non-conforming material
  • Responsible for final product release sign-off
  • Oversees quality needs for the quality control team
  • Assist and/or manage plant projects and drive to completion
  • Participate in audits as process and quality systems
  • Develop root cause investigations CAPA experience
  • Develop an understanding of the validation system and assist in validations.
  • Conduct diagnostic and statistical analysis of methods, equipment, and materials to improve product quality, process reliability and cost
  • Assist in meeting plant team plans for cost and quality improvement, operating within department budget guidelines
  • Demonstrate ability to make consistent and data driven decisions
  • Inspect incoming, in-process, finished parts, and materials for conformance to quality control standards
  • Reports to Quality Assurance Executive
Genel Nitelikler

SKILLS & COMPETENCIES

* Become an authority in application of statistical tools, measurement systems analysis, and root cause analysis, and system validations * Take ownership of projects and drive to completion, whether working independently or in a team * Will work cross-functionally with suppliers and customers in project management and problem-solving activities * Ability to speak, read and write English * Have good knowledge of Microsoft Office * Have an outstanding communication skill, both verbally and in written form * Have excellent organizational and planning skill for proper running of an organization * Be ambitious, have strong work ethic, and a willingness to learn *Be a fast learner with strong problem-solving skills * Positive & winning attitude * Ability to understand and effectively communicate at all management levels, technical dependencies, timeline impact and risks * Good attention to detail * Good eye for design * Creative and technical ability to turn designs into products *

SUPERVISORY RESPONSIBILITIES                                       

10+ quality inspectors 

WORKING ENVIRONMENT

Office work environment. Regional travel 20%.

REQUIREMENTS

  • Bachelor’s degree in biomedical, genetics, biochemistry, and related fields
  • Several years of professional experience in quality management and/or manufacturing
  • Experience at a Pharma, Biotech, or Medical Device manufacturer preferred
Quality Assurance Executive
İş Tanımı

RESPONSIBILITIES & DUTIES

  • Manage the cross functional relations to make sure the quality assurance system run continuously and effectively
  • Ensure to comply overall quality assurance system in CHIL by keeping up to date
  • Devise and establish CHIL’s quality procedures, standards, and specifications
  • Involve producing quality documentation, maintaining quality management systems, carrying out product quality reviews and performing audits to ensure that all devices comply with regulatory requirements
  • Direct and oversee the documentation process
  • Review customer requirements and make sure they are met
  • Work with purchasing staff to establish quality requirements from external suppliers
  • Set standards for quality, as well as health and safety issues
  • Serve as the Management Representative and ensure all relevant processes meet national and international standards
  • Establish and maintain controls and documentation procedures
  • Maintain quality system in compliance with all applicable regulatory standards (FDA, WHO, ISO 13485, ISO 9001, GMP) and other relevant requirements throughout the company
  • Make sure the company is working as effective as possible to keep up with competitors
  • Specify quality requirements of raw materials with suppliers
  • Work with operating staff to establish procedures, standards, and systems
  • Always direct objectives to maximize profitability
  • Train production staff on quality procedures, protocols, and documentation
  • Reports to General Manager
Genel Nitelikler

SKILLS & COMPETENCIES

Become an authority in application of statistical tools, measurement systems analysis, and root cause analysis, and system validations * Take ownership of projects and drive to completion, whether working independently or in a team Will work cross-functionally with suppliers and customers in project management and problem-solving activities * Ability to speak, read and write English * Have good knowledge of Microsoft Office * Have an outstanding communication skill, both verbally and in written form * Have excellent organizational and planning skill for proper running of an organization * Be ambitious, have strong work ethic, and a willingness to learn Be a fast learner with strong problem-solving skills Positive & winning attitude * Ability to understand and effectively communicate at all management levels, technical dependencies, timeline impact and risks *

SUPERVISORY RESPONSIBILITIES                                          

10+ engineer and quality inspectors

WORKING ENVIRONMENT

Office work environment. Regional travel 20%

REQUIREMENTS

  • Bachelor’s degree in engineering, science, or related fields
  • Several years of professional experience in quality management