Quality Assurance Coordinator (CM&Complaints), Cairo - Pfizer

Job Title:

QA Change Management and Complaints Specialist

Reports to:

QA Quality Systems Section Head

Direct Subordinates No.

-------

location:

Egypt, Cairo PGS

Affiliate/Department/Location

Quality Operations Department, PGS, Egypt, Cairo

Position summary: describe in one or two sentences the primary purpose of the job

QA person performing tasks in Change Management System, Product Site Complaint Investigations and Periodic Product Record Reviews performed at Cairo Site.

Also, to ensure compliance with GMP standards, PQSs and regulatory standards are applied within job function.

Job Specific technical/Functional/Professional Competencies:

1- Handling Change Management process:

• Ensure compliance of Change Management System with PQS
• Conduct QA impact assessments for all changes
• Approval of child actions
• Approval of Interims related to Change Management
• One of the approvers of proceduralized changes

2- Product Complaints:

• Responsible for conducting site Complaints investigation reports with ensure compliance of Site Complaints with PQSs
• Project Owner for new CITI module in QTS

3- Periodic Product Record Reviews:

• Responsible for Product Periodic Record Reviews:
  • Ensure compliance of PPRRs system with PQSs
  • Conducting site plan for product periodic record reviews
  • Report OOS results to QA Manager and SQOL
  • Participate in Review and approval of PPRRs

4- Conduct QAP updates in QIS

Experience and Knowledge  

Bachelor degree in Pharmaceutical Sciences

Minimum 1-2 years of relevant experience in Quality Assurance with GMP background.

Essential Personal Qualifications

• Decision Making Skills
• Interpersonal and Communication Skills
• Good Command of English both written and spoken
• Teaching and Coaching Skills
• Self-Motivated
• Team Worker
• Writing Skills

Preferred Qualifications

Internal Auditing

Six Sigma Yellow Belt Certified is a plus

Apply Here