QA Specialist

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their well-being. So, if you share our ambition, join us at this exciting moment in our journey to get ahead together.
 

Quality Executive provides effective and efficient quality assurance systems support to the LOC Quality Manager, including supporting the implementation and maintenance of the Quality Management System (QMS) to ensure that the quality systems required by the LOC element of the Supply Chain and Marketing Company LOC are performed in an efficient way and meet the compliance standards of the QMS linked to GDP and GSP activities, Global Quality standards and the local regulation.

As LOC Qualified Person (QP), you will ensure GDP and GSP compliance of wholesale distribution activities and you will act as a focal point of contact in front of the Competent Authorities for any GSK product quality / technical, GDP and GSP-related matter. Working location is at Kyiv office and Warehouse in Kyiv region, Boryspil district, village Velyka Oleksandrivka.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
 

· Maintain a high level of QMS, GDP and Local Wholesale Regulation knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.

· Support the LOC Quality Manager to ensure a robust, sustainable, and effective QMS by monitoring and reviewing the compliance status within the LOC element of the Supply Chain and Ukrainian Marketing Company

· Quality Risk Management

· CAPA and Deviation Management

· Change Control Management

· Maintain Quality Documentation Management System

· Lead and manage audits related to GDP processes, internal and external audits, self-inspections

· Provide training to all personnel involved in the distribution of pharmaceutical products

· Perform local batch release

· Track GDP, GSP / local wholesale regulation

· Review, conduct impact assessments and implement any updates to QMS procedures.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
 

· Pharmaceutical education (Pharmacy degree is a mandatory with the document of higher education not lower than the second (master's) level in the specialty "Pharmacy", a certificate of pharmacist. specialist, issued by the institution of postgraduate education, or a certificate of assignment (confirmation) of the relevant qualification category

· Experience of QP desired – in the specialty "Pharmacy" not less than two years, responsible for the quality assurance system of medicines during wholesale trade

· Work experience in GxP particularly GDP and GMP areas

· Strong knowledge of regulatory requirements pertaining to cGMP, cGDP, cGSP, pharmaceutical regulations and local Licensing legislation.

· Good knowledge on QMS requirements

· Able to demonstrate continuous professional development in the QP role.

· Fluency in English (oral and written)