Are you a Master in Pharmacy with an interest in Quality and a desire to become a QP? This might be your dream job!
Job Description
As a Quality Associate you support activities and executes tasks in compliance with the Quality Management System and GMP/GDP regulatory requirements.
Responsibilities
- Manages/oversees Product Complaint Intake, including follow-up with customers, Corporate Product Complaints and other third parties. Coordinates product complaint returns. Notifies customers of complaint closure (where required). Activities also include identification of Adverse Events, Medical Information enquiries and potential falsified medicines
- 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 Regulatory Authorities
- Supports Deviations, CAPAs (Corrective/Preventive Actions) and CAPA-EV (effectiveness verification) for Quality issues
- Assists with self-assessments, internal audits and Regulatory Authority inspections
- Assists during mock recall activities
- Authors, edits and updates GMP/GDP documents in controlled document management system
- Manages/supports Customer re-approval process
- Ensures accurate general record keeping
- Become acquainted, maintains and uses Quality systems, databases and other relevant data collection
- Performs Temperature assessments as Temperature Excursion assessor for the European region, ensuring all procedural requirements are met
- Recognizes and escalates problems
- Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
- Ensures compliance within regulatory environment
- Develops solutions to problems of moderate complexity
- Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
- Interprets generally defined practices and methods
- To provide technical support in the maintenance of the affiliate QMS within BENELUX in alignment with GMP/GDP regulations and applicable 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 and other groups
- May set project timeframes and priorities based on project objectives and ongoing assignments
Requirements
- Preferably a Master in Pharmacy or Master in Science with a first experience in Quality
- Understand regulations in relation to Distribution, European Pharmaceutical Directive related to Distribution of Medicinal Products, as well as Good Distribution Practice (GDP), Good Manufacturing Practices (GMP), Falsified Medicines Directive and Medical Device Regulations
- Know about the role of EMA and country health authorities
- Strong word processing, database and spreadsheet application skills
- Fluent in English and Dutch. French is a plus.
- Problem solving skills
- Existing right to work in Europe
Benefits
- Fulltime remote position ( 1 day/week to the office )
- Balanced salary package based upon your experience and capabilities
Vacancy number: 19036
