Quality Manager
City Pharmacy Company Medical Est.
مجموع سنوات الخبرة :19 years, 2 أشهر
• 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