Hala Fathy

Lead the project of the new facility plant of Marcyrl for Sterile, Tablets & Suppositories of hormonal Products

External technical consultant for GMP & GLP for EDA during license /inspection of Pharmaceutical industries in Egypt

Lead and direct plant operations, establish production goals and plans . Manage resources and costs (spending and investments) according to defined plans and in the most efficient manner. Effective implementation of quality systems and ensure compliance of operations according to relevant guidelines

Direct , Manage & Lead all planning manufacturing and packaging operations till customer supply . Ensure manufacturing of the products to meet agreed production and quality targets in accordance with GSK and according to GMP Standard . Cost effective operation and continuous improvements initiatives

Managing Lab activities for finished products, raw & packaging materials for chemical and microbiology testing, analytical method validation and transfer, manage and control lab operating expenses.

Managing all Validation activities in the site Maintain Compliance of Validation activities and ensuring the establishment of validation lifecycle approach Responsible for issuing and updating Site Validation Master Plan Manage site Change Control system Manage Product Periodic Review

Responsible and accountable for batches release to markets. Deviation decision making , investigation , CAPA identification , reporting & approval Customer complaints investigation CAPA identification and approval OOS expanded investigation , CAPA identification & approval Monitoring Process, equipments & cleaning validation activities Change control , PPR , SOPs , validation sign off Batch instructions approval Monitoring of trends relating to quality performance & providing analysis advice for compliance & performance improvement opportunities. Develop anti counterfeit measures to PM Site monthly KPIs , monthly report and RPS quality metrics GMP advice and training

Improve site performance by utilizing OE principles and lean sigma tools / methodologies in order to achieve business goals and targets. Manage the implementation of business process improvements at the site in support of business targets Support the Site Leadership in devising strategy for improvement opportunities. Lead the identification of improvement projects working with other experts and other site members. Make recommendation on overall program of site improvement activities. Train & coaches on lean sigma tools / methodologies and analysis. Ensures the use & implementation of change management tools & techniques.

Packaging supplier’s management through suppliers qualification review. Performing periodic auditing to local suppliers Approve new packaging local and overseas suppliers Review, approve and manage Art works of printed packaging components Create standard Packaging material specification Monitor packaging supplier’s quality performance as a part of supplier’s global performance. Anti- counterfeiting measures managements and monitoring Supervise Packaging material testing and releasing Issue standard operating procedures, methods of analysis and product specifications and all packaging analytical relating activities

Supervisor pharmacist of packaging department for all dosage form Pharmacist in charge for Ointments and Cream manufacturing Co-ordinate with the planner to arrange the products volumes, their sequence and the timing of the Shop Orders release to come out with the optimal plan to hit the monthly and annual targets Follow up and supervise the daily output produced by all subordinates. Solving the technical and managerial problems that is related to the work in the department in co-ordination with the senior production manager Supervise operators and held responsible to ensure that the work is complying with the quality of the work and GMP

In Patient and outpatient pharmacist Managing IV and TPM preparation under aseptic technique. Prepare chemotherapeutic drug as a unit dose Join drug information department to replay to physicians questions on Drug/Drug interactions, drug generic , brand names and calculate right dose to patients

Analyst for Raw material, Finished goods & Microbiology