Supply Chain Quality Operations Officer At Pfizer Egypt
Job Description:
Maintain compliance to the local Board of Health (BOH) regulationsCoordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.
Supports the Responsible Person and/or Qualified Person activities for all Pfizer Product Quality Compliance issues in the market as well as Health Authority Notification and documentation of any notification and any significant verbal communication
Governance & internal organization
Support timely implementation of all applicable Product Quality SOPs (issued by SCMOQ) within the PCO.
Ensure that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.
Assess new quality system and local regulatory requirements to enhances and align local systems and processes when required.
Conduct and document periodic assessments to determine if a revision, retirement, administrative change or no change is required for the Product Quality SOPs (issued by SCMOQ) within the PCO.
Quality Metrics
Collect data and report quality metrics for PCO operations to allow quality performance assessment.
Together with the SCMOQ market lead, assess quality performance to identify trends and improvement opportunities.
Participate in the PCO quality management reviews and follows-up for the recommended actions, when required.
Training
Support the implementation of all elements of SCMOQ Training systems in the PCO, including implementation and refresher training on GDP/GMP to applicable PCO colleagues.
Ensure that all assigned Pfizer trainings (through Pfizer LMS, Learning management system) are completed in a timely manner
Commitment Tracking
Manage commitments resulting from deviation management, change control, local regulatory authorities’ inspections, and internal audits.
Use and maintain tracking tools to track any GxP commitments raised by SCMOQ or under SCMOQ oversight.
For any commitment opened, ensure that due dates are based on risk, complexity and urgency, and that the timeframes given are realistic, to meet the stated requirements.
Completion of all commitment tracking actions as per assigned due dates
Change Controls
Support the initiation and/or manage any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO.
Participate in the change’s committee meeting as appropriate and ensure the required approvals are obtained.
Ensures change action completion as per the agreed timelines.
Inspection and Internal Audit
Lead the preparation and coordination of GMP/GDP related inspections of PCO Pfizer internal/MSQA audits
Work with SCMOQ Market lead and local functions to prepare an appropriate action plan to address the inspection/audit observation
Site Internal Audit (SIA) process management:
Setting the SIA plan according to local needs and subsystems prioritization tool
Ensure the timely implementation of the SIA plan as per the assigned tasks as auditee and / or auditor.
Product Quality Assurance & Operations
Notification to Management (NTM)
Notifies SCMOQ Sr Manager/TL and SCMOQ Regional Lead of significant product quality and compliance issues.
Ensure notification is done within the appropriate timeline and process.
Provide AQRT Executive Summary including local investigation results and proposed CAPAs for issues originating under the responsibility of the PCO as applicable
Ensure the local implementation of actions identified during AQRT meetings e.g. recalls, communication with Regulatory Agency, local CAPAs and provides feedback on progress
Deviation and CAPA Management
Perform, investigation of product quality incidents that occur within the responsibility of Pfizer Country Office in cooperation with the relevant internal/external functions.
Track the preventive and corrective actions until completion within the set due dates.
Product Complaint Handling
Reporting complaints if any to AFME-HUB team withing the defined timeline.
Quality oversight on Local Relabeling operations
Ensure that relabeling sites have been trained and approved before performing any relabeling activity.
When required, ensure that the relevant Regulatory approval for the relabeling activity has been obtained by the regulatory team.
Complete the required documentation and obtain the necessary approvals from Pfizer relevant functions.
Oversee the process of relabeling and review operation related documents.
Ensure SCMOQs release (as applicable) of the relabeled product according to Pfizer and local requirements
Market Action
Attend, as needed (as back-up for example), Area Quality Review Teams (AQRT) meetings, as PCO representative, to provide the local perspective on the issue at hand.
Support to provide the local perspective on the issue and draft the AQRT Executive Summary for issues originating under the responsibility of the PCO.
Support the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions
Quality agreements
Develop, negotiate and maintain up to date quality agreements with all affiliates, GMP/GDP distributors involved in repackaging, storage and distribution activities
Quality risk management
Participate as risk leader or in the risk management committee for any opened risk with PCO
Manage the opened risk and tracking the required approval
Updated risk tracker and archiving the risk assessment report as required
Qualifications/ Skills
Years of experience: 0-3 years in the Pharmaceutical or related regulated industry
Technical skills:
Has an appropriate education in science or quality topics; Bachelor's degree, Pharmacist, Engineer.
Has basic knowledge of the Quality principles, concepts of Quality and basic technical skills
Has basic knowledge about Quality Systems (Change Control, deviations, complaint management, documentation management, audits, inspections, etc.)
Able to Participate effectively in cross-functional team
Analytical skills
Excellent level in English
Soft skills/ Management & Leadership Skills
Self-motivated, Business acumen
Acts Assertively
Grows Self
Accountable
Change Agile
Self-Awareness
Planning & Organizing skills
Able to make decisions within guidelines and policies
Success criteria
To use new ideas and knowledge with increasing frequency, begins to explore and apply ingenuity to experimentation.
Able to work in ambiguous situations as part of a Work Team
Applies technical skills to achieve assigned tasks
Has effective communication, writing and negotiation skills
Able to align with global strategies
Efficiently represents Quality Compliance positions