Quality Assurance Manager
Sandoz
مجموع سنوات الخبرة :10 years, 4 أشهر
Quality Assurance Manager
- Ensures quality of drugs, biologics, devices following regulations.
- Designs quality systems to be efficient and compliant.
- Analyzes data to identify and address quality risks.
- Conducts audits to find and fix compliance gaps.
- Supports inspections and helps resolve any issues found.
- Trains and manages a quality assurance team.
- Investigates quality problems and takes corrective actions.
- Works with manufacturers to investigate product issues.
- Communicates with regulatory bodies about complaints.
- Manages the complaint system and prepares customer responses.
- Monitors and qualifies performance of key suppliers.
- Conducts internal quality inspections.
- Manages change control to avoid negative impacts.
- Provides guidance on Good Storage and Distribution Practices.
1.Insure quality standards set forth in SOP and cGMP.
2.Write SOPs and work instructions
3. Work with managers and teams to assess and ensure compliance with cGMP and company compliance plan against internal (policy/procedure) and external (contract/program) requirements; report regularly on results
4. Develop and maintain food safety plans (HACCP), as well as performing the function of active team leader .
5.Conduct food safety and quality training in various formats to meet the needs of the employees within the parameters of their positions to consistently produce employees who are well trained in the skills and requirements of their position.
6.Maintain all records pertaining to personnel training for food safety and quality .
7.Provide guidance and leadership up to and including operations management in situations where deviations have occurred or a potential risk has been identified related to food safety and/or quality .
Issuance, Archival, Retrieval of documents and Labels including but not limited to:
* Masters and Executed Batch Records
* SOPs Masters and obsolete SOPs
* Masters Specifications and Test Procedures
* Completed Deviations, Out of Specification Reports & Ems
* Completed Change Controls
* Completed Audit Reports and Responses.
* Completed CAPAs report.
* Issue Batch records to floor for execution
* Prepare database for archival and retrieval of documents.
* Initiate SOP/Standardized QCP templates and Training.
* Logbook issuance and maintenance
* Audit Document Support
* Labeling Supplies for projects, Stationary supplies for department.
* ADDITIONAL RESPONSIBILITIES: Work closely with Operations department to assist them in implementing and maintaining effective, risk based GMP processes, procedures, documentation and Artwork issuance.
Working as Microbiology specialist at Quality control department and through working in microbiology laboratory, I got Optimum knowledge about the following:
*Preparation of Media, Rinsing fluids & bactericidal reagents
*Media pouring techniques
*Preparation, incubation & Monitoring environmental plates for sterile areas
*Gram satin and further identifications (BBL Crystal)
*Microbial limit test for finished products ((Non-Sterile)) and raw materials
*Standardization for control inoculum
*Growth promotion test for medias
*LAL test for WFI & Bulk
*Label claim assay test
*Validation of expiry date for solid and liquid media
*Validation of efficacy and expiry date for disinfectant and sporicidal
*Biological indicators Verification of count
*Biological indicators challenge test
*Validation of efficacy of pass through box
*Sterility area qualification For entering and sampling process
*Routine analysis for water sampling points PW & WFI
*Environmental monitoring during production processes for sterile area and non-sterile areas
*Sampling techniques .
*Got optimum knowledge about the following Machines and Equipment: Autoclave (Fedgari), Oven (Memmert), BBl crystal, LAF, Air sampler device, BD phonex, vortex, Hot plate, PH meter, Balance .
The use of biological processes, organisms, or systems to improve products.
BS of biology and diploma in education. Subjects included: • Microbiology. • Zoology. • Cell biology. • Laboratory instrumentation techniques. • Organic chemistry. • Biochemistry • Biometrics. • Vertebrata. • Entomology. • Biological analysis. • Economic Botany.