Heba Nasser

1.Audit preparation -Prepare and update the quality manual and policy for the organization-Make audit plan annually-Prepare audit agenda monthly-Selection of auditor according to qualifications and experiences-Identify the authorities and roles of auditors-Determination of purpose / type and scope of audit 2.Communications and distribution of audit plans ,reports 3.Assess audit program Opening meeting,Data collection,interview the key personnel, review of documents and site visit Audit analysis & follow up

-Dealing with sterile area class B, C, D and E-Ensure that environmental monitoring and equipment validation are conducted as appropriate for evaluating the adequacy of the manufacturing conditions-Make records to facilitate the traceability -Coordinate with QC to evaluate water, air samples to ensure GMP-Ensure application of training and training plans for new employees-Make audit plans and audit reports each month and follow up the corrective actions taken-Follow up deviation, change control & OOS,

-Search about the scientific (medical) data related to each active ingredient or non- active ingredients and its uses, mode of action , indications , dose, dosage forms, storage condition….etc -Coordinate with external designer to make the trials related to each product for our company. -Ensure the distribution of medical data and non-medical data (for supplier, for the product in the company, registration no., reading of bar codes….etc)on the packs -Choose the packaging materials to fit the storage co

-Fill in the batch records / record forms related to each step like; handling of raw materials, storage of raw materials, semi-finished products, final products & distribution. -Supervise the production process in the area of production to ensure the GMP compliance -Prepare the Standard operating procedures (SOP) which shall be available and maintained up to date for all manufacturing operations. -Prepare the recommended storage conditions or handling precautions that may be necessary

Cardiovascular Diseases

Biochemistry