Quality Compliance Manager
AJA PHARMA
مجموع سنوات الخبرة :23 years, 10 أشهر
• Responsible for leading and directing all quality assurance activities at the company, including
manufacturing, quality control, R&D, engineering, and supply chain activities.
• Establish a strong quality-driven culture at the site by managing and developing the Quality Team and
providing mentoring and guidance across all functions.
• Lead all audits and inspections for customers and regulators.
• Prioritize departmental goals and activities according to business needs
• Approve all documents related to subcontractors (Sanofi, Novartis, Janssen, etc.)
• Reviewing and approving documents (SOPs, Policies, Quality Manuals, Protocols, Validation Master
Plans, SMFs, BMRs, BPRs, etc.)
• Managing the quality assurance department's people and resources
• The approval of Quality Assurance Agreements (QAA) with multinational corporations.
• Conducting GMP training sessions.
• Reviewing and approving all market complaints investigations reports
• Approving all change controls requests.
• Reviewing and approving all deviation investigation reports
• Following up of Product Regulatory, Voluntary and Mock Recalls procedure
• Handling of CAPA management
• Reviewing and approving AJA’s Annual Product Review Reports
• Reviewing and approving of Novartis Annual Product Review Reports
• Internal audits team leader
• External audits Team Leader
• Approving the certification of “Vendor validation and Certification programs”
• Creating of Product Accountability System
• Reviewing & Approving of site VMP
• Reviewing & Approving of site calibration plans.
• Reviewing & Approving of site Preventive maintenance plans
• Reviewing & Approving of site Cleaning validation master Plan & protocols
• Reviewing & Approving of site computerized validation master plan & protocols
• Reviewing & Approving of site process validation master plan & protocols
• Updating of Documentation Control Procedures
• Creating AQL System in Finished goods inspection
• Reviewing and approving of warehouse, incubators, stability chambers, refrigerators mappingstudies
• Responsible for preparing the annual GMP training program
• Responsible for preparing the all GMP training materials, videos, presentations and meetings.
• Responsible for conducting training activities for GMP topics.
• Preparing a GMP Training Procedure.
• Preparing a procedure for How to Create a GMP Training Material.
• Conducting the Induction Training for the new hired employees.
• Creating a procedure for Creating Training Objectives and liking them with training success measures
and training effectiveness measures.
• Establishing a GMP Maintenance Education Points System:
➢ All staff within TPMC site are required to earn designated GMP points annually, as determined by
GMP trainer and it will be linked to the employees’ KPIs.
• Managing all training activities related to OJT procedure.
• Managing all training activities related to outsourced training courses.
• Qualifying all outsourced trainers and training academies.
• Establishing a GMP compliance level calculation for the training system during internal / external audits.
Responsible for leading and directing all QA activities associated with manufacturing, quality control, R&D,
Engineering and supply chain activities at the site.
• Manage and develop the site Quality Team and provide mentoring and guidance to site personnel cross all
functions to build a strong quality driven culture.
• Be the lead contact for all customer audits and regulatory inspections.
• Prioritize department goals and activity based on business requirements
• Approving all documents related to the sub-contractors (Sanofi, Novartis, Janssen, and all other suppliers)
• approving of documents (SOPs, Policies, Quality Manual, Protocols, Validation Master Plan, SMF,
BMR,
BPR…etc)
• Managing of people and other resources in Quality assurance department
• Approving Quality Assurance Agreements (QAA)with multi-national companies.
• Implementing of GMP training sessions.
• Reviewing and approving all market complaints investigations reports
• Approving all change controls requests.
• Reviewing and approving of all deviation’s investigation reports
• Following up of Product Regulatory, Voluntary and Mock Recalls procedure
• Handling of CAPA management
• Reviewing and approving of SAJA’s Annual Product Review Reports
• Reviewing and approving of Novartis Annual Product Review Reports
• Internal audits team leader
• External audits team Leader
• Approving the certification of “Vendor validation and Certification programs”
• Creating of Spot Audit System
• Creating of Product Accountability System
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• Reviewing & Approving of site VMP
• Reviewing & Approving of site calibration plans.
• Reviewing & Approving of site Preventive maintenance plans
• Reviewing & Approving of site Cleaning validation master Plan & protocols
• Reviewing & Approving of site computerized validation master plan & protocols
• Reviewing & Approving of site process validation master plan & protocols
• Updating of Documentation Control Procedures
• Creating AQL System in Finished goods inspection
• Reviewing and approving of warehouse, incubators, stability chambers, refrigerators mappingstudies
• Leading Computerized Novatek Quality Management System QMS- at site
• Conducting GXP advanced training for managers, and heads of departments
Improving of quality systems in the company.
• Leading the project of media fill to start producing of sterile products
• Reviewing and approving of all department’s documents.
• Create and implement the AQL system during production and finished goods inspection.
• Following up the implementation of market complaints system
• Following up the implementation of Deviation Control System
• Creating and Following up the implementation of change control System
• Following up the implementation of cleaning validationsystem
• Reviewing and approving of stability procedure andprotocols.
• Following up the implementation of PQRs
• Following up the implementation of training system
• Audit Leader in the internal audit program
• Improving of documentation system
• validation of Tunnels
• validation of sterile area HVAC system
• preparation of media selection, lactose selection and closure integrity testing protocols which are related
to the aseptic filling
• Following up the implementation of process validation.
• Management representative in IS 17025.
• Improving of process validation procedure.
• Reviewing and approving of Validation Master Plan
more and more responsibilities are there and to be mentioned during the interview.
Establishing Validation Department from scratch
• Preparing and approving of Validation Master Plan
• Preparing and approving of Cleaning Validation Master Plan
• Preparing of Validation SOPs, Protocols, Plans…etc.
• Implementation of validation and qualification activities.
• Preparing and implementing of change control system
• Creating of Annual Product Review Procedure.
• Preparing and approving of Process Validation procedure and protocols.
• Management of people and other resources in Validation Department
• Implementing of GMP training sessions.
GMP Compliance Head
• Management of people and other resources in the QA Department
• Implementing of Internal Quality Audit on different departments (QC, Engineering, Warehouse, Production...), preparation of the audit reports and follow up of Corrective/Preventive Actions (CAPA)
• Management of daily GMP Compliance Inspection in the Plants.
• Preparing and approving standard operating procedures, validation protocols ….etc)
• Improving of QA works.
• Implementing of GMP training sessions for all employees.
• Co-ordination with all department managers to face the external audits.
• Follow up and solving the external audits observations
• Follow up of HVAC system operation & qualification
• Follow up of Compressed air operation & qualification
• Follow up of Water treatment qualification and operation
• Follow up of incident reports related to the plants
• Follow up the investigation reports related to the plants
• Implementing of monthly spot audit in the production, packaging and warehouse areas.
• The owner of media fill project in the company (Aseptic filling process validation)
• Co-operation with validation department to prepare cleaning validation protocols.
• Following up change controls implementation.
• Owner of Media Fill Project
• Process Validation Team Leader
• Internal Audit Team Leader
• Reviewing and approving of SOPs, Batch records, Validation Protocols….etc.
Management of people and other resources in the QA Department.
• Suggest and implement steps for improvement of the QA work.
• Checking and approval of data/documents/reports.
• Preparation, review, and checking of batch records archival.
• Helping in preparation of the Process Operating Instructions documents for all packaging stages
(Overprinting, Labeling, Final Packing, Reconciliation).
• Responsible for Training Activities: New employee induction training, training needs list preparation and
follow-up, qualification program for employees & training records review and updating.
• Planning & Execution of Internal Quality Audit on different departments (QC, Engineering, Warehouse,
Production...), preparation of the audit reports and follow up of Corrective/Preventive Actions (CAPA).
• Familiar with SOP control, approval & distribution procedures.
• Familiar with control of all documents (Test procedures, Specifications..etc) including distributionprocess.
• Preparation of Annual Product Review Reports (APR) & Reports with CAPA follow-up.
• Familiar with the QA activities in Warehouse (GMP checks, managing rejected materials, handling the
returned materials, .. etc)
• Follow up market complains, change control procedures, deviation control procedures, returned finished
goods checking procedures, holding & rejection procedures and disposal of rejects & wastes.
• Performing and analyzing of time frame studies.
• Reviewing of QC data trend analysis for water system.
• Reviewing of Micro data trend analysis for water system.
• Preparing of alert and action limits for non-viable particulate matter.
• Working in Validation /Calibration department: -
• Reviewing all validation and qualification protocols
• Reviewing all calibration certificates
• Reviewing of validation master plan
• Reviewing of Lab validation master plan
• Reviewing of Water treatment qualification protocols.
• Reviewing of HVAC system qualification protocols for non-sterile area
• Reviewing of HVAC system qualification protocols for sterile area
• Reviewing of Compressed air qualification protocols.
• Familiar for implementing calibration for measuring devices.
• Familiar for implementing validation for autoclaves and dry heat sterilizers.
• Familiar for implementing validation for UV cabinet.
• Reviewing microbiological lab validation master plan and monitoring programs for sterile and non-sterile
areas.
• Contentiously auditing for validation /calibration department documents.
• Following the qualification schedules for facilities, machines, and supporting systems.
• Reviewing of sterile products closure integrity test protocol.
• Reviewing of IT protocols.
• Reviewing of IT validation master plan.
• Preparing, checking, and reviewing of validation of aseptic filling process.
Implementing of Blend; Bulk; semi-finished and Finished product Analysis.
• Implementing of Raw Materials Analysis.
• Implementing of Analytical Method Development.
• Implementing of Accelerated Stability Study.
• Implementing of ON-Going StabilityStudy.
• Preparing Reports for ValidationPurposes.
• Conducting Training Sessions and Seminars on Various Topics
• Checking of lab records and logbooks of chemists.
Liquid vials filling
• Ampoules filling.
• Powder vials filling
• Manufacturing of sterile liquid products
• Working in final packing and labeling.
• Training of the new employees