Senior Quality Assurance Specialist (12 Month - External Temporary Contract)

Viatris

İstanbul Avrupa Yakası
Geçici
Tam zamanlı

1 ay önce

Meda Pharma Ilac Sanayi ve Ticaret Limited SirketiAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Specialist role will make an impact:Key responsibilities for this role include:

Ensure that all quality assurance operations are performed in accordance with current GMP & GDP and the Ministry of Health regulations.
Supporting the batch release of the locally produced products by checking the batch records and approving the batches for sale.
Supporting the shipment and the release of the imported products by checking the analysis certificates and approving the batches for shipment and sale.
Controlling the test methods and the analytical method validation reports prepared by the contract manufacturers during analytical method updates and technology transfer projects
Supporting product and technology transfer projects, legal entity name change project and other project in terms of preparation and checking documents
Ensuring the current test methods and specifications are consistent with the registration dossier. Determining and implementing the necessary actions together with the Regulatory team.
Initiating and tracking of customer complaints. Ensuring the handing processes are performed in compliance with GMP necessities.
Receiving and evaluating any non-compliance and deviation notifications from the contractors, requesting investigation, commenting on the outcome and proposing necessary actions.
Receiving and evaluating any change requests notified by the contractors, requesting information, ensuring that necessary actions are taken and documented, and commenting on the need for variation submission to the Ministry of Health,
Creating and updating quality SOPs when necessary.

Candidates are expected to have the following qualifications and skills:

Bachelor’s degree in chemical engineering, chemistry, pharmacy or a related discipline
Min 7 years of experience in Quality Control Department at pharmaceutical companies having strong quality control knowledge
Solid knowledge of cGMP and GLP requirements in the pharmaceutical environment
Strong technical writing ability.
Having analytical thinking, problem solving, planning and organizational skills, prone to teamwork.
Computer proficiency in Microsoft Office Set and MRP tools

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Viatris is an Equal Opportunity Employer.

Viatris

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