Quality control and Artwork supervisor

Ahmed Hamed Haddad Yousef Ammar

Contact Information:

Address: **** ********** **-*******, ******* district, Jeddah, Saudi Arabia.

Mobile: +966-**-*******

E-mail: *****.******@******.***

*****.*.******@*****.***

Objective:

To utilize my analytical, quality, management skills and experience in a highly challenging position where I can lead and improve it and also increase my capabilities in a leading multinational company.

Education:

Ain Shams University, Faculty of Pharmacy, Egypt. (2004–2009).

Bachelor of Pharmaceutical Sciences.

Grade: Very Good (with honor).

Work Experience:

Packaging Materials & Artwork Supervisor : Feb 2017 till now at Pfizer Saudi Limited, Jeddah KSA.

Raw / Packaging Materials & Artwork Supervisor : July 2016 till Feb 2017 at Pfizer Saudi Limited, Jeddah KSA.

Professional Experience:

-Update of all Pfizer artworks for new projects.

-Creation of new Artworks for new products at Pfizer Saudi.

-Regular follow ups with regulatory and commercial teams for approval and new designs.

-Review of PILs and Cartons for text and medical mistakes.

-Coordinate will global teams for ePALMS process.

-Coordinate with Pfizer contractors for Pfizer artworks at their plants.

-Submission of new artworks and new regulatory requirements changes with regulatory team.

-Finalize all required Artworks for Serialization and SAT required materials.

-Start-up of the Raw material section, setting plans of the start-up.

-Initiate all SOP related to Raw materials testing, sampling and release.

-Create manufacturing BOMs for all locally manufactured products.

-Passed 3 SFDA Inspections with minor comments/finings.

-Main Quality contact for all Raw materials sourcing for Validation and Stability. In-addition to registration of all raw materials in ministry of commerce and industry for importation license.

Raw and Packaging Materials Supervisor: September 2015 till July 2016 at Pfizer Saudi Limited, Jeddah KSA.

Professional Experience:

-Start-up of the packaging material section, setting plans of the start-up.

-Initiate all SOP related to packaging material testing.

-Initiate all packaging material specifications and testing methods related to these packaging materials.

-Review and approve all artworks.

-Review and approve all products BOMs.

-Creation of warehouse SOPs.

-Training of the new employees and qualification of the team.

-Prepare the Laboratory for SFDA successful inspection.

-Sourcing of the raw materials for the qualification of the machines.

-Supplier qualification and supplier audits for materials and services.

-Generate and control the approved supplier list of the site.

Raw and Packaging Materials Section Head: April 2014 till August 2015 at GlaxoSmith Kline Cairo, Egypt (GSK).

Professional Experience:

Management of Raw and Packaging section:

-Set plans for material analysis and release in corporation of customer needs: Ensure Testing & Release of received raw and Packaging materials within the lead time (8-10 days) and in compliance with GSK standards, specifications, local requirements & GMP.

-Complete the water station phase 3 validation, setting trends and escalate the issue.

-Ensure completing raw materials methods validation.

-Complete raw material specifications update and continue the LABC21 update.

-Ensure sampling per container for all materials we have in compliance of GSK and MOH standards.

-Capacity studies and KPIs generation and improvement of the section.

-All safety requirements and KPIs were satisfactory also start implementing the new requirement for the departmental risk assessment.

Being the sole Quality Contact for GSK Cairo (El Salam):

-All date and requests from SQA&C or SQ Ops were submitted.

-All changes supplied from SQ was handled and internal change controls were issued in response to them to ensure compliance with new standards and changes.

-Handling of supplier complaints and deviations with SQ to get the investigations and the CAPAs for these deviations.

-Tracking the audit reports, BSE, TSE and origin of the materials in the Carisma3 to comply with the GSK and Global requirement.

Continues improvement of the section performance and development of new projects:

-A tremendous improvement of the raw and packaging materials Lead time adherence and quarantined items that leads to improve cycle time of the materials and decrease the production stoppage.

-Initiate the new sampling booth and new sampling room in order to cope with the increased capacity of the raw materials.

-Effective participation in GSK warehouse improvement project:

Participate in the new designs of the warehouses and put all quality requirements.

Improve the capacity of the sampling and reduce lead time of the sampling so improve ware house congestion.

Improve rejection cycle of the materials by applying six sigma tools in this process.

-Reduced testing project re-launching to comply with new GSK standards and GMP. Also, to improve cycle time of the raw materials.

-Continues GAP analysis for GSK policies and GSK CAPs to improve section compliance to standards and to prepare the section for any L1, L2, L3 and even L4 audits.

GPS (GSK Production System) implementation: Raw material section was the pilot for GPS implementation in the quality. Where first 2 items of the GPS were implemented which are PM board and LSW then we started training sessions of the rest of six elements. This implementation was accompanied by updating section KPIs, PM board and the LSW of the section then the other items are in progress to reach maturity levels by the end of 2015.

Handling of Supplier Complaints: the figures of the supplier complaints YTD are within target and achieved for the 2nd year. SOP for AQL had been updated to follow the global standards, also improvement of the process had been implemented as perform many training sessions to different parties, also translate the defects to Arabic to facilitate defect detection and reporting, the YTD figure is about 1% from a target 3%. The alignment with Giza for the standard way of work and better understanding of the AQL was done.

Tracking all the expired and retest items at end of every month and issuing NCMRs for them: The expiry and retest monitoring was implemented to support in decreasing the risk of write offs in the site by alerting the logistics with a list of the materials that will be expired 3 months ahead, This activity had been done monthly.

Develop the section staff expertise through training, mentoring, assigning challenging tasks: this year my team was totally new with high challenges of satisfying our customer needs and quality compliance requirements. This critical phase was successfully passed by achieving very high degree of Self empowerment to all my section staff (Both Raw & Pack) thru distributing very challenging tasks to them, engaging them in critical projects, improving their expertise thru delegation & communication with different company departments that resulted in their development and high competencies.

Raw & Packaging Material QC Analyst: Jan 2011 – March 2014 : GlaxoSmith Kline Cairo, Egypt (GSK).

Q.C Pharmacist: Oct. 2009 – Dec2010: EIMC United Pharmaceutical CO. (EUP)

Quality Control Department (Chemistry Section).

Professional Experience:

Expertise at Raw materials :

-Routine analysis of Raw Materials (API, Excipients, Water samples and Packaging materials).

-Participation in new supplier certification and approval activities.

-Development of new analytical methods for the analysis of non-compandial raw materials.

-Handling of NIR spectrophotometer and building of raw materials library.

-Water station Validation (Sampling, Analysis, Trending and report preparation).

-Sampling of raw & packaging materials.

Expertise in other QC activities including: finished product analysis, Process validation, analytical method development and validation, stability management.

Instrument Handling: - GC Operation, maintenance and calibration including operation of standard operating procedure and periodic maintenance plan.

-Other instruments including: UV-Spectrophotometer, HPLC, Karl Fischer, Auto Titrator, Colorimeter, Total Organic Carbon Analyzer (TOC), Polarimeter …etc.

-Preparation and execution of instrument periodic calibration and annual/biannual maintenance plan, ensuring good agent-customer relation based on dual satisfaction.

Preparation of lab for audits to gain certification and accreditation by well known quality and OHS certification bodies for example: - WHO acknowledgment and accreditation for EIMC’s QC Lab.

-Preparations for EMEA Audits on EIMC Pharmaceutical Manufacturing Facility.

-Preparation of the lab for safety, L2 and other audits included within the GSK annual audit plan.

Managerial/Supervision skills: including

-Identifying & measuring periodic KPIs within Raw materials section

-Supervising the induction & ongoing training of new section crew members

-Short term delegation as the Raw Materials Section head (November 2011)

-Keeping track & observing the 5S implementation, waste management & Lean concept in section processes execution.

Courses & Training:

HPLC Training & Calibration course by AGILENT-Agitec Egypt.

GC. Training course by AGILENT-Agitec Egypt.

HPLC METHOD VALIDATION BASICS & PROCESS DEVELOPMENT by PHARMEX.

UPLC principals and Method transfer by Waters, Vienna

Lean Six Sigma – Green Belt, By Quality Academy Egypt.

Introduction to PMP.

Skills:

Language: Arabic (mother tongue) and English.

Computer: Word, Excel & Power point application.

Personal Data:

Date of Birth: 12.04.1986

Place of Birth: Egypt.

Nationality: Egyptian.

Marital status: Single.

Reference letters available upon request

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