Senior Quality Assurance Specialist

Reposted 9 Days Ago
Be an Early Applicant
6th of October City, Al Jīzah, EGY
In-Office
Senior level
Pharmaceutical
The Role
Lead QA activities for manufacturing and warehousing: monitor environmental conditions, supervise dispensing and production, review batch records, manage deviations and CAPA, ensure GMP/GDP compliance and support continuous improvement.
Summary Generated by Built In

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 Required

  • Bachelor's degree in Pharmaceutical Sciences or 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
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The Company
HQ: Haram, Giza
5,629 Employees
Year Founded: 1997

What We Do

A purpose driven diverse top team that strives to save and improve millions of lives by sustainably offering accessible , high value medicines and health care solutions that address local patients needs Established in 1997, EVA Pharma is built on the heritage of Les Laboratories Delta, Egypt’s second oldest pharmaceutical company. Currently EVA Pharma is one of the leading branded generic pharmaceutical manufacturers in the EMEA region. With a CAGR of 30% over the past seven years, it has proudly earned the title of being the fastest growing pharmaceutical company in the region. EVA Pharma successfully operates in branded generics, OTC, food supplements, herbal medicines and veterinary products with 137 pharmaceutical products covering various therapeutic classes including; Neurology, Psychiatry, Cardiovascular, Orthopedics, GIT, Pediatrics, Urology, and Dermatology. The company is home to cutting edge facilities that are internationally recognized for innovation and the highest quality standards. Its exceptional facilities have earned the stamp of approval from international and regional authorities including European medicine agency, Health Canada, sFDA, & GCC enabling EVA Pharma to be a partner for some of the leading pharma companies in the globe

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