🔹 Job Title: Affiliate Quality Associate
🔹 Company: Roche
🔹 Location: Egypt
🔹 Job Type: Full-Time
🔹 Category: Biotechnology Research
🔹 Date Posted: July 9, 2025
🔹 Experience Level: 2-5 years
🔹 Remote Status: On-site
Key aspects of this role include:
ASSUMPTION: This role requires a strong focus on quality assurance and supplier management, with a significant portion of time dedicated to monitoring and enforcing quality agreements.
✅ Lead the selection, implementation, and decommissioning of GxP suppliers
✅ Provide ongoing quality support and management of all outsourced operations
✅ Monitor and enforce GxP supplier adherence to Quality Agreements using KPIs, audits, and CAPA follow-up
✅ Ensure an uninterrupted supply of the products to the market by releasing commercial product batches to the local market according to local regulations and marketing authorizations
✅ Ensure compliance with GSDP guidelines and regulations for the products distributed locally
✅ Ensure batch traceability for all batches received and distributed by the local warehouse
✅ Ensure appropriate supervision of the supply chain and existence of additional controls for the cold chain
✅ Offer continuous GxP support for warehousing and distribution functions, such as storage, inventory, and transportation temperature monitoring
✅ Perform final product release for compliant batches
✅ Oversee local redressing activities, including the revision and approval of records affecting regulatory information
✅ Manage product destruction processes from a quality point of view
✅ Review physical returns inspection results and determine the final disposition of returned products
✅ Implement and maintain the Quality System by maintaining up-to-date knowledge of the relevant legal requirements and GSDP regulations
✅ Document Management
✅ Develop and maintain local procedures in compliance with the Global Pharmaceutical Quality Systems Documents
✅ Participate in managing complaints, recalls, and returns
✅ Handle deviations, investigations, and action plan follow-up
✅ Participate in managing local corrective and preventive actions
✅ Quality Risk Management planning, identification, quality risk took fill-out, and follow-up including interactions with third parties
✅ Deal with internal and external inquiries about the products' quality
✅ Contribute to the definition and approval of the annual audit plan
ASSUMPTION: This role involves a high degree of cross-functional collaboration, requiring strong communication and coordination skills to work effectively with various departments and external stakeholders.
Education: University degree in one of the following or related scientific disciplines: pharmacy or medicine
Experience: 2-3 years of experience in a pharmaceutical manufacturing and/or distribution domain in the area of Quality Assurance
Required Skills:
Preferred Skills:
ASSUMPTION: While not explicitly stated, having experience in the pharmaceutical industry and knowledge of Roche's Quality System would be highly beneficial for this role.
Salary Range: The salary range for this role is estimated to be between EGP 250,000 and EGP 350,000 per year, based on industry standards for a Quality Associate role in Egypt with 2-5 years of experience.
Benefits:
Working Hours: Full-time, Monday to Friday, with occasional overtime as needed
ASSUMPTION: The salary range provided is an estimate based on market research and may vary depending on the candidate's qualifications and experience.
Industry: Biotechnology Research
Company Size: 10,001+ employees
Founded: 1896
Company Description:
Company Specialties:
Company Website: http://www.roche.com/
ASSUMPTION: Roche's extensive experience and global presence provide a strong foundation for career growth and development.
Career Level: Mid-level
Reporting Structure: This role reports directly to the Quality Manager and works closely with various departments, including Supply Chain, Production, and Regulatory Affairs
Work Arrangement: On-site, with occasional remote work possible
Growth Opportunities:
ASSUMPTION: Given Roche's size and global presence, there are ample opportunities for career growth and development within the company.
Office Type: Modern, collaborative office space with on-site amenities
Office Location(s): Egypt - Field
Geographic Context:
Work Schedule: Full-time, with occasional overtime as needed
ASSUMPTION: The field-based nature of this role may require frequent travel and flexibility in working hours to accommodate different time zones and stakeholder needs.
Typical Process:
Key Assessment Areas:
Application Tips:
ATS Keywords: Quality Assurance, GxP, GSDP, Supplier Management, Stakeholder Communication, Pharmaceutical Industry, Roche
ASSUMPTION: The interview process may include technical assessments or case studies to evaluate the candidate's problem-solving skills and understanding of quality assurance principles.
ASSUMPTION: The specific tools and technologies used may vary depending on the department and regional requirements.
Company Values:
Work Style:
Self-Assessment Questions:
ASSUMPTION: Roche places a strong emphasis on cultural fit and values-driven decision-making, with a focus on integrity, collaboration, and passion for patients.
ASSUMPTION: The role may present challenges in managing multiple priorities, ensuring regulatory compliance, and building strong stakeholder relationships.
ASSUMPTION: While the role shares similarities with other quality assurance positions, the focus on supplier management and the specific industry context set it apart from other roles.
ASSUMPTION: The specific projects and responsibilities may vary depending on the company's needs and the individual's skills and experience.
ASSUMPTION: Asking thoughtful, insightful questions demonstrates your interest in the role and commitment to understanding the company's culture and priorities.
To apply for this position:
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.