QA GMP Supervisor
We are looking for a QA GMP Supervisor for our Gödöllő site!
To ensure that QA overview of manufacturing documentation, process development, change control, audit, deviations is performed according to GMP regulations.
Tasks and responsibilities:
• Proof of cGMP/cGLP and QA regulations on GMP impacted areas, with special regard to technical areas (maintenance, calibration, engineering),
• Handling deviations and change controls on GMP impacted areas, with special regard to technical areas,
• Development and maintenance of practical aspects of GMP regulations,
• Ensures the QA overview on GMP impacted activities, reviews and approves all practical documents,
• Reviews and approves SOPs and work sheets,
• Responsible for communication and supporting of GMP regulations and practical aspects,
• Handling and follow-up change controls, deviations and OOS results: responsible for reviewing and approval of the documents. Ensures that the deviations and change controls are handled on the appropriate level, respecting the mandatory reporting requirements to the Site Quality Council,
• Responsible for the maintenance of the validated status of analytical methods. Responsible for the follow-up of validations and approves validation protocols/reports,
• Taking part in the preparation, organisation, and execution of internal and external audits, and inspections,
• Preparation, participation of the local QA audits, and compilation of the audit reports,
• Responsible for the data compilation for the annual (product) quality review,
• Responsible for the development and maintenance of professional knowledge of GMP regulations and manufacturing operations,
• Responsible for the QA usage decisions on intermediary.
• University degree with scientific orientation (biology, biochemistry, chemistry, pharmacy, quality assurance),
• Advanced English (spoken and written) and fluent Hungarian,
• Analytical and conceptual thinking,
• 2-3 years Quality Assurance experience,
• Strong PC especially in Excel / PowerPoint, SAP.
• Pharmaceutical and/or laboratory experience.
GlaxoSmithKline Biologicals is part of GlaxoSmithKline, one of the world's largest pharmaceutical companies, and is one of the leading vaccine producers. Our teams of researchers are actively working on future vaccines against malaria, HIV, TB, Strep. pneumonia, rotavirus and many other diseases of global importance. The Hungarian plant in Gödöllő manufactures Diphtheria and Tetanus antigens with the contribution of more than 220 colleagues. These antigens are produced for use in combined vaccines worldwide.
What we offer:
• Competitive salary,
• Clean and modern working environment,
• Travel support (company bus).
If you are interested in you may apply for this position online by selecting the „Apply now" button or send your Curriculum Vitae to the firstname.lastname@example.org email address with the position name in the subject.
You may apply for this position online by selecting the Apply now button.
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