Quality Systems Specialist_ Malta Based

Founded in Athens in 2002, PharOS is a privately-owned pharmaceutical Company, developing and supplying generics value added products with a global portfolio. Our expertise covers all aspects of product development from API sourcing up to market release. We provide a broad portfolio of products and intellectual property to leading pharmaceutical companies.

At PharOS, we have a high skilled workforce of more than 430 professionals. Biologists, Chemists, Pharmacists and Experts all focused on developing and placing in the market top quality generic and other value-added pharmaceuticals that improve the lives of patients to more than 98 countries. Our people are our core competitive advantage that helps us being one of the fastest growing pharmaceutical development companies in Europe. For PharOS our customers, are our partners! Our aim is to extend the lifecycle of the product, as our people are able to provide an exceptional level of customer service and support, based on their expertise and professionalism.

PharOS is seeking for a Quality Systems Specialist within the QS department as follows:

Role and Responsibilities

• Manages, executes and upkeeps of the Supplier Qualification Program.

• Ensures logging, tracking, and investigation of Supplier Complaints, and liaises with vendors and third parties to obtain notifications and compliance information.

• Manages the technical agreements.

• Manages and tracks the external/supplier audits.

• Prepares and coordinates for Elemental Impurity and Nitrosamines Risk Assessments.

• Prepares and coordinates for Risk Assessments related to Quality Systems Management.

• Performs approval of Artworks.

• Generates Product Quality Reviews and identifies CAPAs where adverse trends are noted.

• Assists in review and maintenance of CAPAs and Change Controls for compliance with GMP and Regulatory Filings.

• Assists and participates in self-inspection, incoming audits and external audits as necessary.

• Assists in preparation and quality review of Quality Procedures, and Technical Documentation against company procedures and relevant regulatory laws and guidelines.

• Participates in implementation of Quality Systems projects assigned by the QS Manager.

• Assists in cGMP training and other quality systems related training to new and existing staff, as necessary, and documents it according to the procedure.

• Documents any individual training received as per procedure.

• Maintains the Quality KPIs related to QS department.

• Handles the activities in TrackWise Digital and SAP based on roles and rights in respective system.

Experience & Qualification

• Bachelor’s degree in pharmacy, Life Science or another related Field.

• Minimum two (2) years of experience in the Pharmaceutical Industry preferably in Quality Systems or Quality Assurance.

• Organization and planning skills, managing multiple demands, and achieving results with minimal supervision.

• Good written and oral communication skills with particular emphasis on presentation skills.

• Able to present programs and information in a clear and understandable manner.

• Able to adhere to targets/deadline

PharOS Ltd Offers

• Competitive remuneration package (including bonus based on performance)

• Private medical scheme

• Continuous training

• Friendly and challenging working environment

• Relocation package.

PharOS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability.

Please note that your resume and any personal information you have provided will be stored in our system for a period of one year, after which it will be deleted.