Responsible Pharmacist/ PV
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Ημ. ανάρτησηςπριν μία ώρα
Με κάποια εμπειρίαΕπίπεδο εμπειρίας
Με κάποια εμπειρίαΠλήρης απασχόλησηΤύπος απασχόλησης
Πλήρης απασχόλησηΈρευνα & ΑνάπτυξηΚατηγορία θέσης
Έρευνα & ΑνάπτυξηResponsible Pharmacist/ PV
Abbio is a fast-growing Greek company focused on the development, out-licensing and supply of high-quality generic medicinal products and “value-added” medicines. Our portfolio contains solid dosage forms (tablets & capsules), injectables, oral solutions and suspensions. We offer robust supply chains and a full range of services covering all stages of the pharmaceutical value chain, from Product Development to Regulatory Approval and Life Cycle Management.
Currently, given its expanding business, Abbio is recruiting a Responsible Pharmacist/PV, based on the company’s GMP premises in Gerakas area, Athens, Greece.
Main Responsibilities:
- Development of procedures and processes regarding the company’s activities, implementation, maintenance and oversight of the Quality Management System adhering to the requirements of the applicable GxPs (e.g. GDP, GVP).
- Implementation and maintenance of initial and continuous training programs for all quality-related tasks of the employees involved in the distribution of medicinal products.
- Coordinates and promptly performs any recall operation carried out by the company and/or actively assists when one is initiated.
- Management of all customer complaints.
- Qualification of suppliers, customers and subcontractors related to the distribution of the medicinal products of the company and other GxP activities, including auditing where applicable.
- Management of any actual or potential falsified medicinal products that are identified in the supply chain.
- Active role in the improvement of the quality management system by making improvement suggestions to the Management.
- Ensures adherence to national and European regulations regarding drug safety, including timely reporting of safety information to HAs; preparation and submission of Safety Reports (e.g. PSURs).
- Review of product-related documents (e.g. protocol and reports, Certificates of Analysis, Analytical Procedures, Product Quality Reviews etc.).
- Participates in the preparation of the company for accepting audits and inspections by third parties (i.e. clients and competent Authorities) and in conducts self-inspections at regular intervals for compliance with internal policies and QMS, GDP Guidelines and any other National Requirements (whichever applicable).
- Archiving of the company’s Quality documentation and relevant records.
Education requirements:
- University degree in Pharmacy with professional license (license to practice).
- Excellent knowledge of the English language (CEFR Level B2)
- Basic knowledge of Microsoft Office applications
Other Requirements:
- Practical experience in a GMP/GDP/GVP environment is a plus
- Analytical & critical thinking ability
- Ability to prioritize & organizational skills
- Team-working & problem-solving skills
- Good writing skills
- Attention to detail
Company offers:
- Competitive salary
- Friendly corporate culture
- Private Health Insurance
- Training on GxP principles and relevant fields
- Scientific working environment with strongly motivating character
ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ
Responsible Pharmacist/ PV
Γέρακας
πριν μία ώρα
Με κάποια εμπειρία
Πλήρης απασχόληση
Responsible Pharmacist/ PV