Quality Manager

Khaled Ahmed Elsayed +966-***-***-*** ***********.****@*****.***

https://www.linkedin.com/pub/khaled-ahmed-nasr/10/737/105 Page 1 Contacts

Mobile: +966-***-***-***, +2-010*-****-***

Home: +2-02-227*-****

Business e-mail: ******@******.***

Private e-mail: ***********.****@*****.***

Executive summary:

Graduated from Ain Shams University, Faculty of Pharmacy in 2003, with grade Very good.

Working Currently for Arabio as New Product Introduction (NPI) and Technology Transfer Manager.

Certified Production and Inventory Manger (CPIM) by APICS attending program preparation at American chamber of Commerce (March 2014).

Certified Manager of Quality and Organizational Excellence (CMQ/OE) by American Society for Quality (ASQ) attending program preparation at AUC (March 2007).

Certified Six Sigma Green Belt (CSSGB) From Quality America (August 2008).

Certified Quality Auditor (CQA) by American Society for Quality (ASQ) (October 2008).

Certified HACCP Auditor (CHA) from American Society for Quality (ASQ) (October 2009).

Total Quality Management (TQM) Diploma with emphasis on (MBNQA, Six Sigma, Project Management, Planning for top Quality, Statistical Process Control, ISO9001, 14001) at American University in Cairo (AUC) (September 2005).

Certified Lead Auditor (sterile and non-sterile) from Bristol-Myers Squibb Egypt.

Directing the Technology Transfer of solid dosage form (tablets, capsules, soft gelatin and sterile injectable). Responsible for knowledge management, continuous improvement, change management and technical support to maintain portfolio assuring the supply of safe and compliant products with robust and economically sound manufacturing processes.

Quality Expert in various disciplines with Global Corporations in pharmaceutical field, operational and Supply Chain Management experience, along with quality background and core competencies include, environmental health and safety aspects, validation of solids, suspension & clean rooms and sterilization of equipments, risk and crisis management, root cause problem solving, auditing and inspection, budgeting, reporting and implementing of QMS, CAPA & CCR Management.

I was a leader in the lean project for GlaxoSmithKline Egypt Giza site.

I have participated in preparation for 2 global inspections on EUP Egypt to get EMEA Certifications. Personal Data:

Birth Date: March 1st, 1981.

Nationality: Egyptian.

Marital Status: Married.

Current Address: Jeddah, Saudi Arabia. Home Address: Cairo, Egypt. Education:

2013 - 2014: Certified Production and Inventory Manager (CPIM) from APICS. 2015– 2016: Certified Six Sigma Black belt by Quality America (expected to be finalized by end of October 2016). 1998-2003: Bachelor’s Degree in pharmaceutical Sciences, Faculty of pharmacy, Ain Shams University with Grade very good. Khaled Ahmed Elsayed +966-***-***-*** ***********.****@*****.*** https://www.linkedin.com/pub/khaled-ahmed-nasr/10/737/105 Page 2 Job profile:

From August 2014 till present:

NPI (New Product Introduction) & Technology Transfer Manager Arabio (Arab Company for Pharmaceutical Products), Saudi Arabia:

1. Deliver relevant protocols for Method transfer, Production Batch records, Packaging Batch record, QC analytical methods, Analytical Method validation, Cleaning Validation and process validation protocols. 2. Review and update Product specifications, Analytical testing methods, Active Pharmaceutical Ingredients and Inactive ingredients Specifications and testing method in compliance with Arabio specifications. 3. Assess the contract Manufacturer manufacturing and packaging process to be complying with Arabio Specifications. 4. Review and evaluate the Manufacturing conditions, newly issued / updated batch manufacturing records, equipment calibration, and environmental monitoring results. 5. Act as Local Change liaison for technical issues. 6. Review compliance status of the contract manufacturers:

- Randomly attend the production process, randomly review batch manufacturing records.

- Follow up on the CAPA’s and audit requirements.

- Review and evaluate Packaging materials supplier and other service provider selected by the contract manufacturer.

- Participate with contract manufacturers' investigations for complaints of locally manufactured products. 7. Liaising between Contract Manufacturer and RM/PM suppliers to establish QAA. Greatest successes achieved are:

1. Complete technical transfer project for packaging of GSK, Novartis, Janssen and AbbVie human vaccines. 2. Successful Start up of sterile formulation, filling & lyophilizing of vials and Pre-filled Syringe. From August 2013 till July 2014:

External Supply / TPM Coordinator GlaxoSmithKline Egypt: 1. Technical support for Third Party Manufacturer (TPM) of Solid dosage form (Tablets & Capsules) & suspension for product transfer and problem solving for validation activities. 2. Ensure good forecasting for materials & manpower requirements and in the developing of the production schedule according to customer orders and annual demand.

Greatest successes achieved are:

1. Complete technical transfer project of Solids (Tablets & Capsule), Suspension and sterile powder filling with third party manufacturer.

From November 2010 till July 2013:

Production Section Head at GlaxoSmithKline Egypt, Giza Site: Develop the production budget, strategies, based on the sales forecast and aligned with the company goals. 1. Managed a team (production supervisors & Technicians) that working in Solids (Dry and wet granulation, compression, coating), semi-solids production and packaging lines. 2. Technology transfer team member in solid oral, semi-solids and sterile form (from pilot scale to production scale). 3. Participated in factory acceptance tests (FAT) and site acceptance test (SAT) in solid dosage forms (fluid bed dryer, shear mixer, film & sugar coating system, Tablet compression machines). 4. Managing pharmaceutical operations based on increasing overall equipment effectiveness (OEE). 5. Successfully launched a Quality objective (increasing productivity by 25% & yield by 2%) based on six sigma methodology. 6. Wrote many specialized standard operating (SOP's) for operational and training issue's. 7. Responsible for pharmaceutical training courses in cGMP, process Validation, CAPA and documentation control. 8. Ensuring the efficient manufacturing of products with respect to capacity volumes, time, costs and product specifications. 9. Responsible for implementing safety policies and standards to secure personnel and safeguarding machinery. Khaled Ahmed Elsayed +966-***-***-*** ***********.****@*****.*** https://www.linkedin.com/pub/khaled-ahmed-nasr/10/737/105 Page 3 Greatest successes achieved are:

1. Complete project to transfer 2 semi-solids lines (creams, ointment and suppository) from El Salam to Giza site. 2. Managing a team to decrease manual operation to semi-automatic (From 80 % to 15% only). From February 2008 till October 2010:

Production Supervisor at EIMC United Pharmaceuticals (First Anticancer factory in Egypt and Middle East). 1. Supervise 4 Pharmacists and 22 Operators in production area (Central Batch Weighing – Tablet granulation, compression and Coating – Capsule filling - Sterile Preparation - Aseptic Filling area – Blistering & Packaging area). 2. Training for all staff (GMP – FDA – EMA – TGA and WHO regulations). 3. Responsible for Communication with MOH for Pharmaceutical License. 4. A member in Validation committee (performing IQ, OQ, PQ and Process Validation). 5. An Auditor for internal and external supplier audits. 6. Perform Supplier Evaluation (Raw and Packaging materials). 7. Participate in preparing “Annual Product Review” Reports. 8. Startup of Solid area (Capsules and Tablets).

9. Startup of the two Sterile Aseptic Filling areas. Pass 12 successive Media Fill (Vials and Ampoules). 10. Member in global quality audit team establishing auditing implementation and reporting standards. 11. Managing projects of supply chain and quality of excipients and APIs. 12. Managing the validation and qualification of equipments and processes across 2 sterile areas. Greatest successes achieved are:

1. Launch 22 anticancer products to Europe & Asia market. 2. Successful Start up for 2 sterile manufacturing and filling areas, Solids and Liquids departments. 3. Managing a team to run 24 successful media fill for vials and ampoule of 2 sterile areas. From August 2003 till January 2008:

Senior Microbiologist in Q.C. lab at BRISTOL MYERS-SQUIBB EGYPT. 1. Microbiology testing for tablets, capsule, powder suspension and sterile products. 2. Validation activities for Solids dosage forms (Tablets, Capsules & Powder). 3. Sterility Testing using direct and indirect methods. 4. Microbiology Assay for Antibiotic and Vitamins by Turbid metric and Agar diffusion methods (Cup and disc methods). Computer skills:

1. Configuration and using different ERP systems (BPCS & SAP). 2. Excellent at using and programming of Microsoft Office Suite. 3. Programming of .NET framework using C# and SharePoint (Windows and Web Applications). Training:

Date Training Attended

November 2013: Train The Trainer at American chamber of Commerce. August 2012: Leadership Edge in GSK.

June 2012: Root Cause Analysis in GSK.

April 2012: Lean Six Sigma Green Belts in GSK.

July 2010: Project Management in the American chamber of Commerce. November 2009: Problem solving and decision making skills. December 2008: Who moved my cheese in LOGIC center. March 2008: Six Sigma Green Belt in American University in Cairo. February 2008: Clean Room Design by Pharmamex.

December 2007: Negotiation Skills in the American chamber of Commerce. August 2006: Advanced time and conflict management in American chamber of commerce. September 2005: Communication and Reporting Skills in the American chamber of Commerce.

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