Chemist,Quality assurance,Compliance-Document controller
Resume:
Ahmed Khalid Ragab
Contact
Address:-
Sharqiah,Egypt.
Phone:-
Email:-
adhnml@r.postjobfree.com
adhnml@r.postjobfree.com
Date of birth:-
Marital Status :-
Single.
Skills
Attention to detail.
Time management.
Problem-solving.
Multitasking.
Written and verbal
communication.
Ability to work as part of a
team.
Familiar with Ms.office
programs.
Arabic – Mother language.
English – Very good
Objective
I’am seeking a challenging position in a reputable corporation where my academic background and interpersonal skills well developed and utilized.
Position :- (Chemist, Quality assurance &Compliance specialist). Education
Bachelor’s degree in Science in 2016– Specialized in Chemistry - Very Good degree .
Zagazig University.
Experience
Chemist QA&Compliance – from 02/2017 to present.
Delta Pharma Company, 10th of Ramadan, Egypt.
After earning my bachelor’s degree, I spent the last years working as Chemist QA&Compliance Specialist in Delta pharma company in Egypt, where I gained the experience needed to qualify for this position as following:-
Compliance: -
Operate the Change control system.
Operate the CAPA system.
Operate the Deviation system.
Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs Collaborate with other departments to create a culture of compliance.
Assist in the gathering of internal information in response to regulatory requests.
Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
Identify compliance issues that require follow-up or investigation.
Produce monthly key performance indicator (KPIs) on systems as required.
Courses
-Deviation, Root cause analysis
tools, CAPA, Handling non
conformance cases in GMP.
-Auditing.
-QMS ISO 9001:2015 internal
auditor.
-Data integrity,computer
system validaton.
-Effective leadership.
-Presentation skills.
-Comunication skills.
-Strategic planning.
- English courses.
In process control (IPC):-
Monitoring the manufacturing process from dispensing of raw materials stage to all preparation stages, packaging and storage of final product.
Follow implementing labeling system in warehouse of finished products, release of batches.
Ensures Manufacturing Operations compliance with current Good Manufacturing Practices (cGMP), Company Standard Operating Procedures. (SOP)
Documentation
Review of Batch record.
Review of master records.
Product release.
Develop SOP & other GMP Controlled Documents.
Support departments by collecting and coordinating internal compliance data with auditors and various departments
Manage the preparation, issue and control of GMP documents in the Document Management System (DMS)
ensuring that required standards of presentation and formatting are consistently achieved.
Good knowledge of Microsoft Word is required for this work.
Develop and maintain the document archiving system.
Assist implementation of global standards and procedures into the site Quality Systems.
Provide support for regulatory submissions through collation and compilation of documents for inclusion in filings or presentation to auditors as required.
Validation:-
Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for products
manufactured on site.
Follow up all activities of process validation, cleaning validation, calibration.
Packaging materials of product :-
review artwork or any modification artwork of products
Inspection for the daily incoming consignment of secondary packaging materials and release packaging material conducting specification for packaging materials in the warehouse.
Archiving for all retain sample of packaging material.
Contact this candidate