Resha Keny

• Dossier preparation and submission
• Preparation and compilation of CTD
• Submission of application to the authorities.
• Development regulatory strategies of new product.

• Dossier preparation and submission
• Preparation and compilation of CTD
• Submission of application to the authorities.
• Handling of QMS like Change control, deviation, market Complaints.
•Handling of Audit & Audit compliance.

Handling of outfit audit compliance related activities and
preparation for regulatory audits.
 Handling of self inspection and internal audit compliance
 Preparation and review of Quality risk management like FMECA,
FMEA.
 Review of documents for regulatory submission
 Carry out investigations
 Preparation of annual product quality review documents
 Handling of deviations
 Preparation and review of gap assessments pertaining to regulatory
guidelines like WHO, USFDA, PICS
 Assessed and outlined major hazards and risks through robust risk
assessments and management plans.
 Conducted onsite and remote training for job titles in quality
assurances techniques.
 Conducted through inspections of incoming materials, identifying
defects and ensuring compliance with specifications
 Identified problematic area that had deviated from quality standards
and recommended corrective actions.
 Led regular audits on production processes to identify areas for
improvement and maintain quality consistency
 Reviewed and updated quality assurance documentation. Keeping
records accurate and compliant with regulations.
 Assessed QA systems and processes through research, site visits
and reviewing testing evidence
 Prepared detailed reports on audit findings and presented
recommendations to senior management

Human Medicines manufacturing Unit
• Handling of outfit audit compliance related activities and
preparation for regulatory audits.
• Handling of self inspection and internal audit compliance
Preparation and review of Quality risk management like FMECA,
FMEA.
• Review of documents for regulatory submission
• Carry out investigations
• Preparation of annual product quality review documents
• Handling of deviations
• Preparation and review of gap assessments pertaining to regulatory
guidelines like WHO, USFDA, PICS
• Assessed and outlined major hazards and risks through robust risk
assessments and management plans.
• Conducted onsite and remote training for job titles in quality
assurances techniques.
• Conducted through inspections of incoming materials, identifying
defects and ensuring compliance with specifications
• Identified problematic area that had deviated from quality standards
and recommended corrective actions.
• Led regular audits on production processes to identify areas for
improvement and maintain quality consistency
• Reviewed and updated quality assurance documentation. Keeping
records accurate and compliant with regulations.
• Assessed QA systems and processes through research, site visits
and reviewing testing evidence
• Prepared detailed reports on audit findings and presented
recommendations to senior management.
• Food Division of Indoco: Also worked for Auditing facilities to
check for compliance.
• Handling HACCP related activities.

Injection manufacturing Unit
• Preparation and review of Sop
• Handling Lab QA activates related to QC department
(i.e Biochemistry and Microbiology)
• Review of store SOP and other QMS documents
• Review of specifications, STP, Analytical test report, study
protocols, study reports.
• Handling and review of calibration, equipment/area validation and
qualification protocols and reports
• Handling and review of QMS documents such as change controls,
nonconformances, CAPA
• Conducting self-inspection in various departments
• Review of test report and trends of all clean utilities e.g
• Water, pure steam, Gas and Environment monitoring.

Review of store SOP and other QMS documents
 Review of specifications, STP, Analytical test report, study
protocols, study reports.
 Handling and review of calibration, equipment/area validation and
qualification protocols and reports
 Handling and review of QMS documents such as change controls,
nonconformances, CAPA
 Conducting self-inspection in various departments
 Review of test report and trends of all clean utilities e.g
 Water, pure steam, Gas and Environment monitoring.

 Handling the Qualification and Management of API & Excipient
Manufactures/ Vendors
 Perform packing material vendor audits
 Review of Elemental impurity data of raw materials as per ICH
Q3D guideline
 Preparation and Review of SOPs
 Qualification and Approval of Contract testing Laboratories
 Review and approval of Artwork
 Review and Approval of QMS documents such as change control
deviations, CAPA