Quality Compliance Coordinator, Cairo - Pfizer

Job Title: Quality Compliance Coordinator

Reports to: Site Quality Compliance Manager

location:

Cairo, Egypt

Affiliate/Department/Location

PGS

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

• Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Pfizer standards.
• Ensure that appropriate systems are in place to meet or exceed the requirements of the company, ISO and the regulatory authorities for the quality of the products manufactured on site.
• Responsible for Cleaning validation and External Supplier audits.

Job Description and tasks:

• Share in the preparation for and escorting of quality-related audits conducted by Corporate and regulatory agencies.
• Draft responses to audit observations.
• Review Test Notes (Certificate of Analysis) for MOH.
• Interface with MOH inspector to discuss lot records, manufacturing procedures, test results, and labeling.
• Managing Supplier external audit program by setting Annual Plan, follow up its execution, reporting and action completion.
• Participate in Site Self Audit program as a lead auditor.
• Oversee regulatory commitments and Health Authority queries.
• Managing & Execution of Cleaning validation plans through developing of relevant validation master plans and SOPs and Reviewing of validation protocols and reports.
• Assessing emerging regulatory expectations and impact of inspections at other sites.
• Site inspection readiness.
• Quality Systems (e.g. oversight of CAS reports and PQS implementation).
• Change control review to ensure that proposed changes are complying with PQS requirements.
• Develop Data Integrity Plan and deployment of the plan per committed timelines.
• Ensure Compliance of Data integrity within Quality System through Periodic Review of Manufacturing and Laboratory operations.
• Should perform unannounced data integrity surveillance audits.
• Should participate in the investigation and corrective action for reported improper practice.
• Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines.
• Provide feedback to management on periodic basis in relation to overall compliance on data integrity.
• Shall give awareness training on reported observations, share industry insights.
• Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
• Active implementation of Notification to Management procedures.
• Responsibility for compliance with Pfizer Quality Standards.

Experience and Knowledge 

Bachelor’s degree in science / pharmaceutical sciences.

Minimum 2 years of experience in quality assurance or compliance department.

Essential Personal Qualifications

• Good command of English both written and spoken.
• Knowledgeable with interpersonal learning.
• Good Communication skills.
• High Precision and Accuracy.
• Decision making skills.
• High analytical skills.

Preferred Qualifications

• Six Sigma (Green/ Black belt) is a plus.
• Knowledgeable of Pfizer/regulatory quality Standards

Apply Here