BioGeneric Pharma S.A.E is hiring an experienced Quality Assurance Manager in Egypt. Lead cGMP compliance, validation, audits, and regulatory quality systems. Apply now to join a top Middle East biotech company.
Join BioGeneric Pharma S.A.E as Quality Assurance Manager – 2025 Career Opportunity
BioGeneric Pharma S.A.E, a leading biotechnology company in the Middle East, is seeking a highly experienced and detail-oriented Quality Assurance Manager to join our rapidly growing firm. This pivotal role involves overseeing the implementation and enforcement of cGMP standards, managing quality systems, and ensuring compliance with regulatory requirements.
About BioGeneric Pharma S.A.E
Established as a premier biotechnology firm, BioGeneric Pharma S.A.E specializes in the development and manufacturing of high-quality pharmaceutical products. Our commitment to innovation and excellence has positioned us as a leader in the Middle East’s biotech industry.
Job Title: Quality Assurance Manager
Location: Egypt
Department: Quality Assurance
Experience Required: Minimum 14 years in pharmaceutical QA
Education: Bachelor’s degree in Pharmaceutical Sciences.
Key Responsibilities
- cGMP Compliance: Ensure adherence to current Good Manufacturing Practices across all departments.
- Quality Systems Management: Develop, implement, and maintain quality assurance policies and procedures.
- Validation Oversight: Supervise process and cleaning validation activities, approving relevant protocols and reports.
- Documentation Control: Review and approve SOPs, protocols, reports, and other quality-related documents.
- Audit Management: Lead internal audits and represent the QA department during external audits, ensuring timely CAPA implementation.
- Product Release: Oversee the release of finished products, ensuring compliance with marketing authorizations.
- Change Control: Review and approve change control reports, deviations, and incident reports.
- Regulatory Affairs Support: Approve CTD Quality Modules and quality registration files before submission.
- Training and Development: Identify training needs and conduct GMP, GLP, and other quality-related training programs.
- Risk Management: Develop and implement risk management plans to mitigate quality-related risks.
Qualifications and Skills
- Educational Background: Bachelor’s degree in Pharmaceutical Sciences.
- Experience: At least 14 years in pharmaceutical quality assurance.
- Leadership: Proven ability to lead and manage QA teams effectively.
- Regulatory Knowledge: In-depth understanding of cGMP, GLP, and regulatory requirements.
- Analytical Skills: Strong analytical and problem-solving abilities.
- Communication: Excellent verbal and written communication skills.
- Attention to Detail: High level of accuracy and attention to detail.
- Project Management: Ability to plan, prioritize, and manage multiple projects simultaneously.
Why Join BioGeneric Pharma S.A.E?
- Innovative Environment: Be part of a company that values innovation and continuous improvement.
- Career Growth: Opportunities for professional development and career advancement.
- Competitive Compensation: Attractive salary and benefits package.
- Impactful Work: Contribute to the production of life-saving pharmaceutical products.
Application Process
Interested and qualified candidates are encouraged to send their updated CVs to: Email: hr@biogenericpharma.com
📌 Subject Line: Applying for Quality Assurance Manager.
Note: This job description provides a comprehensive overview of the Quality Assurance Manager role at BioGeneric Pharma S.A.E. Candidates are encouraged to review the responsibilities and qualifications carefully before applying.
