Quality Compliance Section Head

Reposted 2 Days Ago
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El Omrania El Gharbia, Qesm El Omrania, Giza, EGY
In-Office
Senior level
Pharmaceutical
The Role
Lead site quality compliance activities including deviation management, change control, PQR coordination, internal audits, CAPA verification, KPI reporting, inspection readiness, and coaching to maintain GMP compliance and 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 Quality Compliance Section Head 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:
• Manage the site's deviation system, ensuring timely investigation, root cause analysis, and closure of quality events.
• Oversee change control activities, ensuring all changes are properly assessed, approved, and implemented in compliance with GMP requirements.
• Coordinate and review annual Product Quality Reviews (PQRs), analyze quality trends, and support continuous improvement initiatives.
• Manage internal audits, support regulatory and customer inspections, and ensure timely closure of audit observations.
• Review, monitor, and verify the effectiveness of CAPAs resulting from deviations, audits, complaints, and quality reviews.
• Monitor quality compliance KPIs and prepare periodic reports for management.
• Ensure GMP compliance across site operations and support inspection readiness activities.
• Coach and support team members while promoting a strong quality culture across the site.


Requirements

• Bachelor's degree in Pharmacy.

• 6–8 years of experience in Pharmaceutical Quality Assurance.

• Previous experience in Quality Compliance, including deviations, change controls, audits, CAPAs, and PQRs.

• Strong knowledge of GMP requirements and pharmaceutical quality systems.

• Experience in handling regulatory inspections and audit activities is preferred.

• Strong analytical, communication, and problem-solving skills.

Skills Required

  • Bachelor's degree in Pharmacy
  • 6-8 years of experience in Pharmaceutical Quality Assurance
  • Experience in Quality Compliance including deviations, change controls, audits, CAPAs, and PQRs
  • Strong knowledge of GMP requirements and pharmaceutical quality systems
  • Experience handling regulatory inspections and audit activities
  • Strong analytical, communication, and problem-solving skills
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The Company
HQ: Cairo
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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