About the Role
Viatris Egypt S.A.E. is seeking a highly skilled Quality Control Manager to join our team in Egypt. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs worldwide. As Quality Control Manager, you will play a critical role in ensuring that all products meet the highest standards of quality, safety, and regulatory compliance.
Key Responsibilities
- Develop, implement, and maintain comprehensive quality control systems and procedures in line with international standards (GMP, FDA, EMA regulations).
- Oversee all quality assurance and quality control operations across manufacturing and packaging processes.
- Conduct thorough product testing, sampling, and analysis to ensure compliance with specifications and regulatory requirements.
- Lead internal and external audits, ensuring readiness for regulatory inspections and certification renewals.
- Manage and mentor the QC laboratory team, fostering a culture of continuous improvement and scientific excellence.
- Investigate deviations, out-of-specification (OOS) results, and non-conformances, implementing effective corrective and preventive actions (CAPA).
- Review and approve batch records, stability studies, and validation protocols to ensure product release meets all quality benchmarks.
- Collaborate closely with production, R&D, regulatory affairs, and supply chain departments to drive quality across the product lifecycle.
- Monitor and report on key quality metrics (KPIs), driving data-informed decision-making and process optimization.
- Ensure compliance with environmental health and safety (EHS) standards within all QC operations.
Required Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biochemistry, or a related scientific discipline.
- Minimum of 5–8 years of experience in quality control/quality assurance within the pharmaceutical industry.
- Strong knowledge of pharmaceutical regulations including GMP, ICH guidelines, and local Egyptian regulatory requirements.
- Proven experience with analytical techniques such as HPLC, GC, UV-Vis spectroscopy, dissolution testing, and wet chemistry methods.
- Demonstrated ability to lead cross-functional teams and manage complex quality projects.
- Excellent problem-solving and analytical skills with a strong attention to detail.
- Proficiency in quality management systems (QMS) and documentation practices.
- Strong communication and reporting skills, both written and verbal.
Preferred Skills
- Experience with regulatory submissions and dossier preparation for product registration.
- Familiarity with lean manufacturing and Six Sigma methodologies.
- Knowledge of stability study design and ICH stability guidelines.
- Certification in quality management (e.g., ISO 9001 Lead Auditor, ASQ CQA) is a strong plus.
- Experience working in a multinational pharmaceutical environment.
- Proficiency in English language for documentation and cross-border collaboration.
Why Join Viatris Egypt?
At Viatris, you will be part of a global healthcare leader committed to empowering people to live healthier lives at every stage. We offer a dynamic, inclusive work environment where innovation and scientific excellence are at the forefront. Joining our Egypt office means contributing to a mission that impacts millions of patients across the region while growing your career within a world-class pharmaceutical organization that values professional development, diversity, and meaningful impact.