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Eva Pharma

Posted 4 months ago

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Senior Quality Assurance Specialist

6th of October CityOn-siteFull-time

AI Summary

Senior Quality Assurance Specialist is responsible for ensuring GMP/GDP compliance across manufacturing and packaging operations, reviewing batch records, handling deviations, and driving CAPA and continuous improvement.

About this role

Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.

Job Summary

We are seeking a passionate and talented Senior Quality Assurance Specialist to join our dynamic team.

The ideal candidate will contribute to our mission of enhancing human health and well-being,ensuring that we meet the highest standards of excellence in our industry.

Key Responsibilities:

  • Monitor and oversee environmental conditions (temperature, humidity, and pressure differentials), ensuring consistent compliance with GMP requirements across production and warehouse areas, and provide guidance on any observed trends or deviations.
  • Supervise raw material dispensing activities, ensuring adherence to specifications and verifying calculations in line with approved SOPs.
  • Provide oversight of manufacturing and packaging operations, ensuring full compliance with GMP, SOPs, and data integrity requirements, while supporting continuous improvement initiatives.
  • Review and approve batch records and logbooks, ensuring completeness, accuracy, and compliance with GDP standards.
  • Lead the handling of deviations, non-conformities, and incidents, including conducting or supporting root cause investigations and ensuring effective implementation and follow-up of CAPA.

Requirements

  • Bachelor's degree in Pharmacy.

  • 2-4 years of relevant experience in a pharmaceutical QA environment.

  • Strong knowledge of cGMP and GDP principles.

  • Solid understanding of CAPA, change control, deviation management, and quality documentation systems.

  • Familiarity with ISO 9001, quality systems, and safety programs.

  • Good understanding of validation principles and basic statistical concepts.

Skills

Basic StatisticsBatch RecordsCAPACAPA InvestigationsCGMPChange ControlData IntegrityDeviation ManagementGDPGMPGxPISO 9001LogbooksQuality Documentation SystemsQuality SystemsRoot-cause AnalysisSOPsValidation Principles

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