شاهين دوراني

• To manage Quality assurance functions throughout the supply chain in Dubai and across UAE to ensure highly disciplined compliance with all the products, process quality parameters and standards.
• To control, maintained all warehouse facilities across UAE and plan, execute periodically Internal Audit program for all Divisions & warehouses operations as per ISO standards.
• To coordinate with MR for setup, enforcement and management of Quality Management System & Environment Management System, company policies & procedures in line with ISO accreditation and Its compliance, principal companies and local regulation requirements.
• To generate reports, documents and information that allow operational team to more effectively manage the business from quality perspective.
• To coordinate with MR/Assistant-MR for conducting of Annual internal quality management meeting and to take initiatives to implement discussed agreed action plan.
• To develop and maintain all the relevant documents in the course of compliance for principal company’s and local regulatory requirements.
• To liaise during audits from principal company & local authorities audits & follow up with the different departmental head for effective implementation of corrective and preventive actions.
• Oversee investigation, root cause analysis and closure of customer complaints. To handle product recalls and development of corrective and preventive actions

 Validation Documentation Management:
Preparation of all validation and qualification documents (Policies, SOPs, validation master plans, protocols, and reports)
 Process Validation :
Preparation and executing validation protocols and reports in cooperation with the responsible person for each of the following validation subjects
Cleaning Validation;
 Cleaning validation for different lines like Oral Liquids, Semi Solids, Capsule, Tablets lines and preparing the protocol and collecting and filling the data.
 Equipment & System Qualifications:
Performing and preparation of DQ, IQ, OQ & PQ templates for Equipments & Machines.
 Utilities Validation Issues
• HVAC system validation
• Water system validation
• Compressed air qualification
 Handling of Customer Complaints, Deviation, OOS and Change Control
 Preparation of Site master file and performing the required annual reviewing for it.

Responsibilities:
 Validation Documentation Management:
Preparation of all validation and qualification documents (Policies, SOPs, validation master plans, protocols, and reports)
 Process Validation :
Preparation and executing validation protocols and reports in cooperation with the responsible person for each of the following validation subjects
Cleaning Validation;
 Cleaning validation for different lines like Oral Liquids, Semi Solids, Capsule, Tablets lines and preparing the protocol and collecting and filling the data.
 Handling of Customer Complaints, Deviation, OOS and Change Control
 Preparation of Site master file and performing the required annual reviewing for it.

Production In process control activities in Sterile and Non-Sterile Plants:
 GMP inspection of Controlled and Production Area.
 Very well know the all In process control activities of all dosage forms includes Sterile (LVP, SVP), Non Sterile (Tablet, Capsule, Syrup, Suspension, Dry Powder Suspension, Cream, Ointment, Gel & OTC products