Most*************

QMS, SOP, QA, Data integrity, documentation, deviations, quality, ISO 9001:2015

  • 23511 Alexandria Egypt 
  • Graduation: BSc Pharmaceutical sciences, Zagazig university, Egypt

  • Hourly / Daily / Monthly Rates: N/A

  • Languages: English(Full Professional)

  • Last Update: 30.01.2022 at 09:46

Availability
Not Available
Place
Alexandria
Country
Egypt

Category :

Quality Assurance and Business Operations

   

Keywords :

  

Account Manager


Skills

Work Experience:
Compliance Section Head – Quality Assurance, Pharco Pharmaceuticals, April 2021– Present.
o Execution of Quality Compliance programs employing tracking and trending tools to assess root cause and risk management; including change control, Corrective Action Preventive Action, deviations, OOS.
o Supporting QA and compliance team in preparing the plant to any audit in relevant areas.
o Supervising & revision for all investigation reports for any raised OOS or any incident/deviation from any department in the company with assigning suitable CAPA.
o Following up deviations recommended CAPA implementation with all concerned personnel.
o Defining, suggestion, and implementation of appropriate Quality Assurance approaches to effective solutions and CAPA actions based on sound principles, industry/regulatory standards, and robust scientific basis.
o Communication with other departments to address findings and facilitate problem solving.
o Solving quality related issues in an efficient and timely manner.
o Participation in the preparation and updating of Compliance SOPs for relevant tasks and review other departments SOPs.
o Periodic Review and Trend analysis of Deviation, OOS, change control and CAPA systems.
o Perform internal audits through all department to ensure the correct implementation of cGMP guidelines.
o Communication with other companies regarding outsourcing activities and preparation of any related documents including Quality agreements.
o Performing product recall and Mock recalls
o Completion of any other tasks assigned to me by my direct manager.


Production section head – Liquids Section, Pharco Pharmaceuticals, September 2017 – Present.
o Participation in the startup of Povidone Iodine Section till the approval from Legal authorities.
o Internal Trainer (cGMP, Data Integrity, GSP, GDP, GDocP and First Aids).
o Leading teams on process improvement projects by using the Six Sigma methodology and Developing and maintaining Lean manufacturing/ Six Sigma theories and principles into practical applications.
o Translating production requirements into daily work schedule and direct staff in various departments in the execution of the work to meet production requirements as per schedule.
o Ensuring staff is trained and adhere to Health & Safety procedures, GMP and SOP regulations.

Production Pharmacist, Sanofi Egypt, May 2015 – August 2017.
o In New oral Liquid Plant, July 2016 – Present, Supervising production activities concerning manufacturing of syrup, suspensions and Elixirs in preparation, filling and packaging sections.
o Performed 6 months rotation in Solid dosage forms section, January 2016 – June 2016. Supervising production activities including granulation, Compression, Coating and Capsule units.
o In Liquids, Semisolids and Suppositories Sections, May 2015 – December 2015. Supervising production activities during Preparation and filling processes.
o Active participation in the startup of the new oral liquids plant till the approval from legal authorities.

Quality Assurance Officer, Multi-Apex Pharma, November 2014 - April 2015.
o Following up dispensing, manufacturing and packaging processes and activities in the production sections and ensuring its compliance with cGMP guidelines.
o Participation in Handling and follow-up of GMP Compliance activities including: Deviations and CAPA’s, Changes through following change control procedures, Out of limit investigations and Complaints investigations.
o Manufacturing and Packaging Batch Review & Batch release.
o New Leaflets and Boxes data reviewing.
 Production Pharmacist, Sigma pharmaceutical Industries, March 2011 – October 2014.
o Supervising Production activities in Liquids section including syrup, suspensions and liquids for external use in preparation and filling units.
o Supervising Production activities in the New Semisolids section including ointments, gels & creams in preparation, filling & packaging units.

Production Specialist, Delta Pharma, May 2010 - February 2011.
o In Liquids section including syrup, suspension, drops and liquids for external use in preparation and filling units.
o In Semisolids section including ointments, creams & suppositories in preparation and filling units.


Refrences

New Semisolids section start up in Sigma Pharmaceuticals.

New Oral Liquids Plant start up in Sanofi Egypt.

New Povidone Iodine Section start up in Pharco Pharmaceuticals


Time and Spatial Flexiblity

To be discussed

Get In Touch


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