سناء عباس

Basic Function
Ensures compliance with cGMP, regulatory requirements, GLP compliance
Ensures that pharmaceutical products are manufactured to a safe and consistent standard
Planning, scheduling, executing and leading validation project assignments and calibration plans
Control of documentation system


Main Tasks and responsibilities

Authorizes all controlled documents. (SOPs, protocols, forms. List….)
Authorizes all planned changes to the quality system.
Manages process validation-
Manages the change control process.
Manages the deviation and non-conformance handling process.
Manages the self-inspection activity.
Manages the quality system evaluation activity and authorizes any improvements and updating
Manges cleaning validation
Manages training system
Manages qualification of facility premises, equipment and utilities, Lab instruments
Manages calibration system
Manages URS documents and FAT / SAT tests
Manages product quality annual review
Manages product (batch records review) and release
Manages Risk Management process.
Manages Site Master Plan and Validation Site Master Plan.
Manages QA inspection and release activities of products
Provides support to QA employees in charge of special projects

Basic Function
•Manages development of new products and provides technical support for production department.
•Designing and maintaining strategies, procedures and methods up to JPM standards.
•Improving and developing working systems.

Major Outputs:
•Strategic:

•Identifies, develops and implements the department strategies.
•Ensure integration and coordination between R&D department and production department during optimization and scale up phases.
•Participate as an active member in the "Material Review Board" especially in assessing and solving technical problems faced by production and Quality Control Departments.
•Assists in designing and implementing of process validation
•Development of department employee’s knowledge, skills and efficiency.
•Keep up with updates of regulations and industry requirements related to products development
•Operational:

•Plan for the new products to be developed each year.
•Assign the sections head and members responsible for developing each product.
•Follow up products development through the sections head and the specialists through the presented reports and documents.
•Approve all specifications and methods of analysis documents.
•Approve all manufacturing formula documents.
•Approve the registrations files.
•Organizing and performing product reformulation when needed.
•Provide for and follow up the training program for each employee at R&D.
•Evaluate periodically the department performance.
•Represent the sponsor at the Contract Research Organization (CRO) and takes responsibility for assigning a monitor for monitoring the bioequivalence studies according to Good Clinical Practice (GCP) guidelines.
•Approve all protocols and final reports submitted by the Contract Research Organization (CRO).
•Manages the R&D Department personnel affairs (evaluations, promotions, vacations).
•Collaborate with the formulation and analysis specialists and with the sections head in preparing and updating all documents in the department required for the work process e.g. : Standard Operating Procedures ( SOP's ), guidelines, forms …etc)

Hayat pharma

Basic Function
•Ensure compliance with cGMP, regulatory requirements, GLP compliance
•Ensure that pharmaceutical products are manufactured to a safe and consistent standard

Main Tasks and responsibilities

•Authorizes all controlled documents. (SOPs, protocols, forms.list….)
•Authorizes all planned changes to the quality system.
•Manage process validation-
•Manages the change control process.
•Manages the deviation and non-conformance handling process.
•Manages the self-inspection activity.
•Manages the quality system evaluation activity and authorizes any improvements and updating
•Manges cleaning validation
•Manages training system
•Manage qualification of facility premises, equipment and utilities, Lab instruments
•Manages calibration system
•Manages URS documents and FAT / SAT tests
•Manages product quality annual review
•Manages product (batch records review) and release
•Manages the quality system evaluation activity and authorize any improvements and updating.
•Manages Risk Management process.
•Manages Site validation and management of site VMP.
•Manages QA inspection and release activities of products
•Provides support to QA employees in charge of special projects

Basic Function
•To plan, organize and lead all calibration/ verification and maintenance activities in production department, engineering department and laboratories to achieve effective work flow, and ensure that all equipments and lab instruments are working properly, according to standard engineering references, pharmaceutical regulations and standard operating procedures system.
•Improving and developing working systems.

Major Outputs:

•Strategic
•Manage calibration activities to ensure producing within the predetermined specifications and quality standards.
•Ensure full integration and coordination between all technical departments to achieve effective functioning of production machines and utilities.
•Assists in designing and writing calibration/ verification strategies and in commissioning activities related to his work.
•Assists in monitoring and controlling maintenance costs related to the engineering aspects of utilities, production machines and Lab’s instrument.
•Planning and scheduling planned and unplanned work as required.

2-Operational
•Manage calibration activities related to operating production equipments, all supportive services, utilities and lab. instrument.
•Manage calibration programs of routine, periodic, preventive, emergency and corrective calibrate.
•Set up performance measures regarding operations on machines including:
•Productivity.
•Performance.
•Overall equipment efficiency.
•Breakdowns.
•Ensure that all instruments are operating efficiently with minimum waste and optimum cost.
•Ensure that the calibration and technical work on machines and lab. instrument is according to required standards.
•Manage all calibration/ verification and technical activities related to engineering, in the stages of:
•Decision making.
•Determining the technical specifications.
•Technical follow up and performing required evaluation.
•Installation of equipment including calibration and validation.
•Participate in technology transfer activities regarding engineering aspects of machines, utilities and technical issues (Internally and externally).
•Finding new suppliers offer best quality of equipment of spare parts.
•Coordinating with other managers to ensure that all systems are operating directly.
•Participates effectively in equipment qualification through participate in the preparation and revision of validation and qualification protocols and any relevant documents of the following:

3-additional Duties (projects)
•Participate effectively in the implementation of Balanced Scorecard through the SWOT analysis, Design of strategy map to align activities to the vision and strategy of the organization, improve internal and external communications, and monitor organization performance against strategic goals.
•Lead each of marketing, HR, purchasing and finance department in establishing their systems according to ISO 9001 requirements through:

•Define the scope of the ISO project in collaboration with ISO committee
•Create a detailed work plan which identifies and sequences the activities needed to successfully complete the ISO project
•Determine the objectives and measures upon which the ISO project will be evaluated at its completion
•Execute the project according to the project plan
•Monitor the progress of the project and make adjustments as necessary to ensure the successful completion of the project
•Ensure that the ISO project deliverables are on time at the required level of quality
•Evaluate the outcomes of the project as established during the planning
•Participate effectively in the engineering and technical projects in the organization

4-External (projects)
•Active participation in the Centre of Excellence for Pharmaceutical Industries through participation in the preparation of all the training curriculum to be used in the training of enrolled at the .

Basic Function
•Participates effectively in the management of all validation activities in the company through the design, establishment, application and maintenance of a comprehensive system for validation
•Participates effectively in validation and revalidation activities through the preparation, execution and revision of validation documentation including (system requirements, design documentation, qualification protocols, test activities, test acceptance criteria, exception and corrective action documentation and change control documentation) with a focus on GMP impact.
•Participates effectively in the sum total of quality assurance functions to maintain the company’s compliance status according to cGMP and other GxP


Major Outputs:
•Validation and qualification Plans:
•Develops and revises validation master plan and sub plans that identify requirements and documentation to meet regulatory requirements of processes, cleaning, utilities, facilities and systems validation
•Coordinates and participates in the preparation and revision of validation and qualification protocols and any relevant documents of the following:
•Equipment, utilities (eg HVAC and water system, …etc), instruments, facilities and systems (IQ, OQ, PQ)
•Cleaning validation
•Process validation (prospective, retrospective)
•And all other types of validation
•Validation Activities:
•Coordinates and participates in the execution of validation and qualification protocols
•Reviews qualification results, determines acceptability and ensure that test exceptions are properly documented and corrected.
•Prepares, reviews and evaluates final qualification reports
•Coordinates and participates effectively in Engineering Department activities through the preparation and revision of Engineering Standard Operating Procedures and system descriptions documents.
•Coordinates and participates effectively in all technical departments activities through the participation in amending and preparation of necessary SOP’s or work instructions in accordance with recommendations from validation reports
•Validation Documents Revision and Management
•Ensures that all validation criteria are met and that the systems will be maintained in valid status according to regulatory requirements and set acceptance criteria
•Participates in validation documents management through coordination with the documentation team
•Ensures that all engineering department activities will be maintained in compliance status according to approved SOP’s, GMP and Good Engineering Practice guidelines.
•Inspection, Self inspection and auditing
•Participates effectively in the preparation for several successful inspections by MOH inspectors, from different European, African, and Arab countries
•Cooperates with the compliance team to conduct self inspection and auditing at all technical departments
•Change Control
•Reviews and assesses the impact of changes on validation status using appropriate change control procedures, making recommendations and suggesting corrective actions.
•Cooperates with the compliance team to revise and update the change control system to support keeping validation status for all critical systems components

I was responsible for:
•Compilation and revision of existing validation documentation for the new manufacturing facility (AL-RAZI Site) including (system requirements, design documentation, qualification protocols, test activities)

Major Outputs:-
•Develops validation master plan and sub plans that identify requirements and documentation to meet regulatory requirements of processes, cleaning, utilities, facilities and systems validation