Qualified Person_ 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 Qualified Person within the Quality Operations department as follows:

Role and Responsibilities

• Prepares and periodically reviews standard operating procedures as required.
• Acts as one of the nominated Qualified Persons on the Company’s licence for the release of pharmaceutical product to market or studies sponsor in the case of IMP’s.
• Ensures that the quality system is prepared and maintained in accordance with all relevant regulatory guidance.
• Ensures that all products are manufactured and documented in accordance with the appropriate regulatory requirements.
• Ensures that nay non-conformances with procedures or cGMP is investigated, documented, properly reported and resolved according to the relevant standard procedure.
• Approves and closes-out any Customer Complaint Investigations and, in case of a Critical Product Quality Complaint or potential recall, is responsible for alerting higher management and/or notifying health authorities as necessary.
• Takes a final decision on batch disposition and releases and certifies batches to be used for human consumption and IMP purposes, ensuring compliance with the laws in force in that Member State and in accordance with the requirements of the Marketing Authorisation/Product Specification file as applicable.
• Ensures that imported batches of medicinal product coming from third countries have undergone all the tests and checks required as per the GMP Directive to ensure quality in accordance with the requirements of the Marketing Authorisation.
• Takes a final decision on a product recall and, in the event of a recall, ensures that a recall is carried out according to site procedures and ensures relevant authorities are notified.
• Ensures Product Quality Reviews for the products manufactured and released on site are generated, reviewed and approved.
• Leads or participates actively in quality work-groups as necessary.
• Ensures that all equipment is purchased, installed, validated and re-validated according to the cGMP.
• Reviews and approves Validation and Qualification documentation.
• Liaises together with the Head of Quality with Local and Foreign Health Authorities, ensuring the proper licensing of the company’s products and operations as necessary.
• Undergoes continuous personal development training, including cGMP, and to also train necessary company personnel as required.

Experience & Qualification

• Bachelor’s Degree in Chemistry, Pharmaceutical Science or related field from an accredited college or university.
• A minimum of two (2) years of progressive management experience or senior supervisory role.
• Registered as a Qualified Person with the Pharmacy Council.

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.