Category

Description

• Tasks**:
• Provides support for Quality Control, Quality Assurance activities, release of incoming materials, and for the assessment and approval of supplier and local investigations.
• Ensures proper and timely approvals of all Quality Control investigations requiring QA approval in accordance with relevant SOPs take place.
• Supports the evaluation, review of suppliers’ investigations and ensures their proper and timely approvals.
• Responsible for review and approval of investigations related to activities of Quality Control Department (QC IR), and their corrective and preventive actions
• Provides timely data and ensures that the Quality Council and Quality Management System review indicators are maintained at appropriate levels and participates in related meetings.
• Supports the review of the Quality Control Department’s SOPs and is responsible for their approval as subject matter expert..
• Responsible for the review of Certificate of Analysis of the Active Pharmaceutical Ingredients and their availability to the Qualified Persons.
• Responsible for the review of Certificate of Analysis of the Finish Product and their availability to the Qualified Persons for release.
• Responsible for review and timely approval of the documents regarding to the analytical method transfers (protocols, reports) and transit trials (protocols, reports)
• Provides support for the trainings of Quality and other function in Laboratory investigations.
• Provides assistance in the training and mentoring of other members of staff in all aspects of GMP and other areas, as appropriate.
• Participates in internal audits and agency inspections.
• What you will need to succeed**:
• Educated to degree level preferably in the field of Pharmacologist, Chemist, Chemical Engineer
• Minimum 5 years experience in pharmaceutical drug product QA and QC position in a wide portfolio of dosage forms (preferably to include oral solid dose).
• Excellent knowledge of English and Hungarian both in written and verbal
• Have a clear understanding of the practical application of the rules of pharmaceutical GMP.
• Experience delivering complex projects on time in budget.
• What you will get in return**:
• Competitive salary
• Cafeteria
• Free meal for lunch
• Commuting support

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