القائمة الرئيسية

الصفحات

Supply Chain Quality Operations Officer At Pfizer Egypt

 Supply Chain Quality Operations Officer At Pfizer Egypt



 


Full Job Description

Maintenance of the compliance to the local BOH regulations

Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.

Support Qualified Person activities for all Pfizer Product Quality Compliance issues in the market.

Support Health Authority notifications and Documentation of any notification and any significant/verbal communication in scope of JD

Governance & internal organization

Supports timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO for the following systems

Quality Metrics

Support Collection of data related to quality metrics of quality systems under responsibility to allow quality performance assessment.

Together with the SCQ Market lead, assess quality performance to identify trends and improvement opportunities.

Participates in the PCO quality management reviews and follows-up for the recommended actions, when required.

Change Controls

Initiate any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO.

Participates in the changes committee as appropriate and ensures the required approvals.

Ensures change actions completion as per the agreed timelines.

Reviews change control and signs change control form

Handling of Global and local SOPs:

Responsible for follow up and assessing impact of newly updated global SOPs

Responsible for review, update and maintenance of local SOPs

Commitment Tracking

Tracking any GxP commitments raised by SCQ or under SCQ oversight Including Egypt and Sudan market under scope of responsibility.

Notification to Management

Informs SCQ Market lead of any significant deviations and complaints, that could lead into a NTM and Ensure notification is done within the appropriate timeline and process.

Quarantine Alert Notice (QAN)

Responsible for creation of QAN report for products / lots impacted with any quality issues

Change the status of the impacted products / lots by QAN on PBG SAP system either Hold or release after resolving the quality issue.

Forward the QAN report to the qualified Logistics service provider to ensure changing the products /lots status at their side to the desired status either Hold or release

Product Complaint Handling

Reporting of any product quality complaint to AfME Hub in timely manner

Management of Label Text errors:

Maintain the process of Label text error and ensure compliance to GSOPs

Ensure compliance to reporting timelines and appropriate reporting level

Deviation Management

Ensure Compliance of PCO to Pfizer deviation management Procedure

Perform, if needed, investigation of product quality incidents that occur within the responsibility of Pfizer country office in cooperation with the relevant internal/external functions.

Local Product Disposition & Temperature excursion

Participate in visit with MOH inspector for release document to provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Pfizer procedures.

Management of reference standards:

Support maintaining stocks of reference standards needed for analysis of products

Support Periodic review of stocks to ensure they are matching with Products analysis needs

Local Repackaging/Relabeling operations

Ensures that contractors have been assessed and approved before performing any relabeling/repackaging activity.

Returns

Assessment of the returned goods and provide a disposition decision

Management of Quality Agreement:

Responsible for creation and maintenance of Quality agreements for PCO Egypt vendors and service providers.

Management of Distributers and Contractors

Support quality operations at contractors or provide feedback to the appropriate functions

support and participate in MSQA audits

Support with contractors/LSPs on action plans to address observations noted during the audits or visits

Market Action

Attend, as needed, Area Quality Review Teams (AQRT) meetings, as PCO representative, to provide the local perspective on the issue at hand

Inspection readiness / Auditing:

Responsible person to keepan acceptable inspection readiness state for Egypt PCO for both Pfizer internal and external / Regulatory quality audits

Support in CAPA developmentfor both Pfizerinternal and external / Regulatory quality audits.

Participate in quality audit for local distributers including audit preparation, execution, and reporting.

Agree on CAPA plans with the audited distributers

Drug shortage reporting:

Reporting Out of stock situations to Drug shortage department at BOH

Responds to routine notifications inquired by drug shortage

Quality risk management:

Ensure Compliance of quality Risk management process to Pfizer standards

Participate as Risk leader or in the risk management committee for any opened risk

LSP / contractor management & oversight

Participates as needed in contactors visits/ audits.

Reviews, negotiates and tracks, according to the market lead instructions and maintain up to date Quality Agreements of GMP/GDP contractors

Qualifications:

Years of experience: 0-5 years in the Pharmaceutical or related regulated industry

Technical skills

Has an appropriate education in science or quality topics, Bachelor's degree of pharmacy

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

Basic level in English

Soft skills/ Management & Leadership Skills

Self-motivated, Business acumen , Act Assertively , Accountable, Change Agile ,Self-Awareness

Planning & Organizing skills

Able to Make decisions within guidelines and policies



Work Location Assignment: On Premise


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