Job Description

QA Officer | Machelen area

Belgium Pharmaceuticals
Posted by Katleen Broeckhoven on 20/06/2019

Do you have a scientific background or a degree in pharmaceutical sciences with a specific interest in QA? Please don’t hesitate to contact us because we have an interesting opportunity for a company with an international distribution environment.

Objectives

  • To provide technical support in the maintenance of the affiliate QMS within BENELUX in alignment with GMP/GDP regulations and the company’s standards, policies and procedures
  • To act as an interface with customers and staff for quality-related issues
  • To facilitate the effective working relationships between International Distribution Quality staff, affiliate staff (Belux and Netherlands affiliate) and International staff
  • To Support & cooperate with Mgr QA and take responsibility in case a backup is needed

 

Position Specific Tasks

  • Supports activities and executes tasks in compliance with the company’s Quality Management System and GMP/GDP regulatory requirements, specifically:
  • Manages/oversees Product Complaint Intake, including follow-up with customers, NL Quality Assurance and other third-party partners. Coordinates product complaint returns. Notifies customers of complaint closure (where required).  Activities also include identification of Adverse Events, Medical Information enquiries and Brand Assists with temperature excursion assessments
  • Delivers training to personnel on Quality-related activities, including maintaining training assignments, training records and assisting with training material development
  • Maintains Key Performance Indicators (KPIs) for Quality-related activities
  • Assists with Quality-related enquiries from internal staff, external customers and Reg Authorities
  • Supports non-conformances (NC) and Corrective/Preventive Actions (CAPA) for Quality issues
  • Assists with self-assessments, internal audits and Reg Authority inspections
  • Assists with tests of recall effectiveness
  • Authors, edits and updates GMP/GDP documents in the company’s controlled document environment ensuring that Corporate, Site and Regulatory requirements are met
  • Manages/supports Customer re-approval process
  • Become acquainted, maintains and uses the company’s Quality systems, databases and other relevant data collection, ensuring accurate general record keeping

 

Expectations/scope/complexity

Knowledge

  • Specialized knowledge within own specialty area
  • Deepens knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Knowledge of Dutch is a must

 

Problem Solving

  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
  • Ensures compliance within Regulatory environment
  • Develops solutions to technical problems of moderate complexity
  • Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
  • Interprets generally defined practices and methods

 

Autonomy

  • Works under general direction
  • Work is guided by objectives of the department or assignment
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments
  • Recognizes and escalates problems

 

Contribution

  • Contributes to work group/team by ensuring the quality of the tasks/services provided by self
  • Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup
  • Provides training/guidance to others and acts as a technical/scientific resource within work group/team
  • Establishes working relationships with others outside area of expertise

 

 

Similar Vacancies