QA Manager

Mostafa Tag El Din Abo-Zied

* **** ** ***** **., Eldokar, Belbies, Sharkia, Egypt

Mobile: +2-012-********

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

QUALIFICATIONS

Total Years of Experience: +10 Years

ISO 9001:2015 QMS/Lead Auditor by SGS Egypt. Certificate no. 40737067/129986089.

Master Degree in Medical Microbiology (Sep. 2011)

Zagazig University, Faculty of Science

Title: Microbial Infection Control in Zagazig University Surgery Hospitals.

Medical Microbiology diploma

Suez Canal University (2008).

Bachelor of Science in Chemistry and Microbiology

Zagazig University, Benha Branch. May 2005

WORK EXPERIENCE

Date: August 2017 till now

Employer: Penta Pharma Egypt

Position: QA Deputy Manager

Responsibilities:

Achieves QA operational objectives by acting as the point of contact for Quality matters for assigned brands and/or Contractors.

Determines QA strategy for assigned brands by studying product requirements; identifying regulatory concerns; analyzing options for product stability and process validation; recommending, preparing, and presenting corrective action plans; contributing information and opinion to cross-functional teams; preparing implementation plans and timelines.

Supports new product introductions from an operational perspective. Reviews and approves documentation associated with the introduction or transfer of a new or existing product to Contractor. These include but are not limited to stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports. Ensures that product dossiers are maintained and current.

Evaluates the effectiveness of Contractors’ quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing Contractor response adequacy and timeliness; determining system improvements. Escalates all serious cGMP and regulatory compliance issues to department leadership. Coaches Contractors where quality systems are deficient; drives remedial action where necessary.

Defines the quality obligations and responsibilities of Contractors by preparing, negotiating, and reviewing Quality Agreements.

Assures the quality of commercial product by reviewing and approving Contractors’ change controls, deviations, nonconformances, and out of specification investigations. Initiates and conducts internal change controls, planned deviations, and investigations where applicable.

Prepares reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as Stability, Complaints, Nonconformance Reports, Deviations, Investigations, CAPA for Annual Product Reviews.

Protects organization's competitiveness by keeping information confidential.

Maintains professional and technical knowledge by tracking national and international regulatory/governmental developments; attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.

Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments

Date: October 2015 till August 2017

Employer: Natural Wellness Egypt

Position: QA Assistant Manager

Responsibilities:

Determining, negotiating and approving internal quality procedures, standards and specifications.

Participate in management review meeting and setting the most appropriate actions for discussed points.

Determine, approve, and evaluate internal training sessions (ISO 9001:2015, ISO 17025:2005, cGMP, cGLP, ICH E&Q, NRDHM, OECD GLP, and OECD TGs) to increase the effectiveness and knowledge of the company staff to be future successors.

Participate in determining external training sessions required for all company staff.

Assessing and setting customer requirements and assuring that all are met.

Participate in product complaint and recall activities.

Prepare, implement and approve internal audit plan.

Evaluate and participate in the approval decision of all service providers (Pharmaceutical Manufacturing Facility, Bioequivalence Centers, Clinical Research Organizations (CRO), Scientific Research Centers, Animal Laboratories, Medical laboratories and Calibration/Validation centers).

Auditing all service providers to ensure that their systems are matching with the required guidelines (ISO 9001:2015, ISO 17025:2005, cGMP, cGLP, ICH E&Q, NRDHM, OECD GLP, and OECD TGs) and in-house requirements.

Participate in risk management regular meetings and follow the implementations of approved actions.

Review and approve all company documents such as contracts, protocols, interim reports .etc.

Ensure the integrity and validity of all the studies and the experimental results.

Review job descriptions of all the staff.

Manage the quality team to perform the assigned tasks with the predetermined time frame.

Date: April 2013 – May 2015

Employer: Egypt Otsuka for Pharmaceuticals

Position: QA Supervisor

Responsibilities

1-Main responsibilities:

Product recall:

Responsible for products recall from local market only.

Testing the compatibility of our recall system through tests of mock recall, product traceability and mass balance.

CAPA:

Responsible for handling and completion of CAPA requested due to self-inspection, management review, deviations, complaints, recall, internal rejection, APRs, internal audit, external audit or audit parties.

Auditing:

Participate in passing audits of ISO 9001 and ISO 14001.

Participate in external auditing on service providers to facilitate the annual supplier evaluation process.

Participate in internal auditing on different areas.

Prepare all reports of internal and external auditing process

Training:

Identifying training needs to all staff in my areas.

Participate in training of all quality department staff acc. to annual training plan.

Continual on-job training to improve quality of each process.

Risk assessment:

Perform risk assessment for all deviation in all processes related to manufacturing processes.

Validation:

The main responsible person of cleaning validation processes of all production lines (SVP, LVP and tablet area).

2- Supervision responsibilities:

In Process Control:

Ensuring that cGMP regulations are followed in sterilizers, tablet and SVP production areas.

Ensuring that cGSP regulations are followed in RM, PM and FG stores are followed.

Arrangement of visits of “pest control”.

Overseeing the production process.

Following up the preparation of tablet and SVP products.

Controlling RO water station unit.

Ensuring that production is cost effective.

Ensuring that products are produced in a timely manner and are produced within quality guidelines.

Foreseeing potential problems before happening.

Liaising among different departments.

Supervising and motivating a team of workers.

Continual evaluation of all operators according to cGMP.

Documentation:

Revision and issuing of QA SOPs.

Preparation documents needed for exportation of our products.

Revision and release of BPRs of tablet products.

Validation:

Participate in validation of HVAC system and its corresponding areas (tablet, SVP and WH areas).

Participate in validation and qualification of some machines (SVP machine, high shear mixer of tablet, tablet dryer, tablet blender, tablet compression).

Process validation of tablet products.

Equipment:

Millipore for filter integrity test.

Metone 3400 for air particle counter.

UVX Digital Radiometer for validation of UV lamps in SVP production line.

Testo surface thermometer with Testo printer.

TSI for calculating air velocity.

Jofra pressure calibrator.

Sound meter.

Lux meter.

Oxygen analyzer.

Dry fog apparatus.

DOP for validation of HEPA filters.

Tablet friability tester.

Tablet disintegration tester.

Tablet thickness and hardness tester.

RPM calibrator.

Total Dissolved Oxygen Detector.

3- Process improvement:

Generated the project of reducing the amount of returned FGs where investigations were done to determine the root cause which finally resulted in decreasing the retuned amount by about 50% during 2014 in comparison with 2013. (2013-2014)

Generated a method of calibration of Oxygen analyzer internally instead of sending it to USA. (2013)

Increased the effectiveness of tablet inspection process by standardizing the inspection machine parameters for each product. (2013)

Modification of the SVP production line to improve cleaning procedures then, generated the cleaning validation project in which resulted in preventing the cross-contamination took place a long time before (2013).

Date: Permanent employee: May 2010 – March 2013

Temporary employee: November 2006 – April 2010

Employer: FRESENIUS MEDICAL CARE EG

(For Haemodialysis Solution Industries)

Position: Senior QA chemist

Responsibilities

In Process Control:

Ensuring that cGMP and HSE regulations are followed.

Overseeing the production process.

Following up the preparation of haemodialysis solution.

Controlling RO water station unit.

Ensuring that production is cost effective.

Responsible for optimum manpower planning by consulting with HR responsible to meet production targets & keeps over time under control.

Ensuring that products are produced in a timely manner and are produced within quality guidelines.

Foreseeing potential problems before happening.

Liaising among different departments.

Supervising and motivating a team of workers.

Continual evaluation of all operators.

Training:

Identifying training needs to all company staff.

Participate in training of all staff acc. to annual training plan.

Continual on-job training to improve quality of each process.

Documentation:

Revision and issuing of SOPs of all departments.

Modification of all SOPs of QA, Production and Microbiology departments.

Working on Microsoft Dynamics Axapta 2009 to control production yield.

Prepare most of documents needed for exportation of our products.

Prepare daily, weekly, monthly and annual reports on the total production processes.

Perform annual supplier evaluation.

Participate in internal audit and external audit to suppliers.

Date: November 2006 – July 2009

Employer: Ceramica Cleopatra Group

Position: Quality Designs QA chemist

Responsibilities

Ensuring that HSE regulations are followed.

Ensuring that all production lines work acc. to the received plan.

On-job training of all operators to GMP of ceramic industry.

Follow up the preparation of new colors and glazes and follow up its approval after QC analysis.

Follow up application of newly/reworked prepared glazes and colors on production lines and follow up its approval after analysis in designs QC lab.

Ensuring that viscosity and weight of glazes on all production lines are in approved limits.

Ensuring that viscosity/density of colors on all production lines is in approved limits.

Ensuring that all documents needed for starting the production process is controlled and all departments are ready to starts up.

Ensuring that IPC records are issued immediately during the production process.

Ensuring that all new tones (of the tiles) are different from old ones.

Issuing release certificates to all produced tiles.

Participate in daily audit of Higher Committee of Tiles Inspection.

External Conferences

I represented the QA department in Egypt Otsuka for Pharmaceuticals in the 5th technical conference of Otsuka International of Asia & Africa and Otsuka Pharmaceutical Factory (OIAA-OPF) from 2/12/2013 till 7/12/2013 in Naruto city, Japan.

Training courses

ICH GCP E6 (Oct. 2015)

OECD GLP (Oct. 2015)

OECD TGs for toxicity studies (Nov. 2015)

ISO 9001:2015 QMS/Lead Auditor by SGS Egypt. Certificate no. 40737067/129986089

cGMP regulations.

HSE & Emergency Planning Skills.

Communication skills.

Safety and hygiene.

HACCP.

Production and Operation Management.

ISO 9001, ISO 14001, ISO 13485, ISO 18001, ISO 14644, ISO 10002 and ISO 10013.

ICDL.

Pharmacovigilance.

SKILLS

Dynamic and ambitious.

Management skills.

Excellent interpersonal skills.

Team building skills.

Analytical and problem solving skills.

Decision making skills.

Effective verbal and listening communication skills.

Attention to detail and high level of accuracy.

Effective organizational skills.

Stress management skills.

Time management skills.

Patience and self-confidence.

Good judgment.

ADDITIONAL SKILLS

Languages:

Arabic: Native (Mother tongue)

English: Excellent. (Professional working proficiency)

PERSONAL INFORMATION

Birth date: 29th September 1984

Nationality: Egyptian.

Marital State: Married (+ 1 son)

Military Service: Exempted.

Driving License: Valid.

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