QA Manager
MONTAJAT Pharmaceutical Co. LTD
مجموع سنوات الخبرة :16 years, 9 أشهر
1. Create basic requirements to be aligned with GMP & GLP.
2. Develop & Create Quality Management System (QMS) and Standard Operating Procedures (SOPs) to control, maintain, improve and evaluate all processes being implemented throughout Montajat Agrochemicals Co.
3. Dealing with all External Audits in order to get new international market share, and getting the best score for customer satisfaction evaluation.
4. Preparing & Approving Quality Policy, Quality Manual & Quality plan
Achievements:
1- GMP certificate From National Drug Authority (NDA) Uganda.
2- GMP certificate From Veterinary Drug & Animal Feed Administration & Control Authority of Ethiopia (VDFACA), Ethiopia.
3- Got ISO 9001:2015 certificate after Developing and Implementing Quality Management system QMS.
4- Implement New Procedures such as: BMR, Sampling Plan (Military STD), Retained Samples …etc.
5- Decrease Customer complains ratio from 4% to 0.2% last year.
6- Cost reduction by implementing new procedures which led to decreasing the time of change over cleaning & decreasing man power as well.
Responsibilities:
1- Issue, implement & maintain Quality Management System (QMS), Quality Policy, Quality Objectives, Standard Operating Procedures (SOPs) ...etc
2- implement preventive measure and corrective action for non-conforming products (CAPA).
3- Issuing, reviewing & Approving Batch Manufacturing Records (BMR) for each batch with respect to critical control points (HACCP) & Safety precautions (OHSAS) 18001.
4- Supplier evaluation program & updating Approved Supplier List quarterly.
5- Reviewing & Approving raw material & Packaging Material testing and other related testing and ensure testing is in compliance to internationally accepted guidelines.
6- Reviewing & Approving Semi-Finished & Finished Products test reports in order to ensure that test results are in compliance to our specifications.
7- Manages Internal audit program.
8- Lead and manage the QA/QC team in order to achieve 100% implementation of the overall Quality Management System, policies and SOPs to support proper and smooth execution of all Quality related activities in meeting the specified standards and requirements
• Preparing, implementing & maintaining the below mentioned SOPs with respect to all documentations:
1- Customer Complain & Recall
2- Supplier Evaluation
3- Change Management
4- Nonconformity
5- House Keeping
6- Document Control
7- Management Review
8- Training Program
9- Validation
10- Industrial Hygiene
11- Internal Audit
12- Calibration
13- QA Final Release for Raw/Packaging Materials & Finished Products.
14- Pest Control
Responsibilities:
1- Prepare the Batch Production Document (BPD) and the Master Manufacturing Document (MMD) and the Technical Files for All the Products (Bill of Materials BOM, Method of Manufacturing MOM, Finished Product Specification FPS).
2- Perform all Raw Material, Packaging Material & Finished Product analysis.
3- Record all analysis result and perform Control Chart.
4- Retained Samples System.
5- Chemical & Reagent Handling & Expiration Control.
6- Documentation System.
7- Test Method Validation.
8- Validation.
9- Standard Samples.
10- Calibration & Verification for Lab Equipment's.
11- Manage & Lead all Shift Chemists.
12- Solve Problems during product realization.
B. HSE & Environmental Hazard Evaluation
Social Fund For Development & the Ministry of Environment established an Environmental Lab to analysis and monitor all industrial hazards and making an Evaluation Study for Port-Said Industrial Zone.
3. Assistant Manager for Environmental Lab
In This Position I am responsible for
i. Determining the pollution value and compare that value with The Success Criteria of The Egyptian law for saving the environment ( Law 4 for 1994)
ii. Collect samples for being analysis from factories.
iii. Analysis of water and wastewater.
iv. Determining the pollution value of air.
v. Prepare a detailed report including all results of wastewater & air Hazards.