PharOS Ltd

Qualified Person (QP)

Posted: 7 minutes ago

Job Description

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 highly skilled workforce of more than 430 professionals. Biologists, Chemists, Pharmacists, scientists all focused on developing and placing in the market top quality generic and other value-added pharmaceuticals that improve the lives of patients in more than 98 countries. Our people are our core competitive advantage that helps us be 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 (QP) as follows:Role & ResponsibilitiesActs as one of the nominated Qualified Persons on the Company’s licence for the release of pharmaceutical product to market or to study sponsor in the case of IMP’s.Provides QP GMP declarations if required.Reviews study and lot specific documentation necessary to facilitate QP Release. Uses technical knowledge to assess the criticality of any issues.Liaising with the Regulatory Authorities.Provides support for resolution of technical problems involving existing global supply productsActively encourages input/development of QMS, Site Quality/EHS Councils and Continuous process improvement.Manages the batch disposition process to ensure timely release of productIs experienced in auditing suppliers, consultants, API facilities, and drug product manufacturing or testing sites.Ensures the batch disposition process maintains compliance with site practices & regulatory requirementsSupports major investigations, ensuring all product deviations are closed prior to batch releaseProvides advice and directions to other departments on quality issuesEnsures independence of the QP on decisions on quality related mattersBuilds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.Experience & QualificationBachelor’s degree in Pharmacy recognized in European Union At least two (2) years of working experience within Pharma Industry, not necessarily as a QPExcellent English oral communication and writing skillsExcellent organizational and communicational skillsTeam working spiritAbility to deliver under specific and demanding deadlinesWillingness to travel up to 25% of the timeImportant Note: The selected candidate will need to apply to Malta Medicines Authorities and pass the relevant examination in order to be appointed as a Qualified Person. PharOS Ltd OffersCompetitive remuneration package (including bonus based on performance)Private Health & Medical Insurance including a 24/7 support LineDaily free transportation from/to the Company’s HQs to nearby public means of transportationCanteen with discounted prices and daily cooked mealsContinuous trainingFriendly and challenging working environmentPharOS 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.

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