MOHD HAZARULHISHAM BIN MAT ZAID
Validation Consultant
SHAH ALAM
Summary
Experienced in Quality Management (QM), Qualification & Validation (Q&V) especially Computer Software Validation/ Assurance (CSV/CSA) and been involved in various pharmaceutical/ life science projects both local and global. Previously, worked in a few pharmaceutical manufacturing facilities.
Current role is Validation Lead who is responsible to lead the group of developers and testers for quality oversight and cGxP compliance of the operation for global pharmacovigilance systems.
Overview
14
14
years of professional experience
11
11
years of post-secondary education
Work History
Validation Consultant
Accenture Solutions Sdn. Bhd.
02.2020 - Current
- Acting validation manager for Malaysia's office.
- Leading validation in projects and system maintenance in various areas.
- Skilled in reviewing validation plan and system design documents, authoring, or reviewing validation plans, system design documents.
- Support project management, CSV, Software Development Lifecycle Models in pharmaceutical industry or related.
- Involve in the quality maintenance and support of regulated applications.
- Involve in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11.
- Participating in implementing the validation process and practices.
Validation Specialist
Rieckermann Engineering Operation Sdn. Bhd.
02.2018 - 01.2020
- To ensure compliance to regulatory requirements in engineering designs through risk assessments and design reviews for pharmaceutical facilities.
- To prepare, review and execute validation activities.
- To participate in GMP audits, validation consultancy and training program.
- Become a key part of the ISO 9001 Quality Management System implementation team within the organization.
- Collaborate with the Quality Director and colleagues from other divisions within personnel area of expertise as required.
- PROJECT EXPERIENCES
- Ain Medicare; Computerized System Validation (CSV); Site location: Kelantan, Malaysia
- Validation Specialist; HVAC System Qualification– New Pharmaceutical OSD Facility; Site location: Melaka, Malaysia
- Validation Specialist; Validation Document Review– New High Potent Drug Facility; Site location: Selangor, Malaysia
- GMP Specialist; Conceptual and Basic Design– New Pharmaceutical Facility; Site location: China
- GMP Specialist; Conceptual and Basic Design–New Pharmaceutical Factory; Site location: Saudi Arabia
Validation Engineer
Nova Pharma Solutions Sdn. Bhd. (NNE Pharmaplan)
02.2017 - 02.2018
- To design, commission, qualify and validate Bio / Pharmaceutical manufacturing facility.
- To support the business development efforts in design, validation protocol preparation.
- To assist in technical presentation to customer as well as responsible for engineering execution and project management including site supervision, plant commissioning, qualification and validation.
- PROJECT EXPERIENCES
- Facility and Utilities Qualification (Water System)– New Biopharmaceutical Facility; Site location: Taiwan
- Facility and Utilities Qualification– New Nutraceutical & OSD Facility; Site location: Negeri Sembilan, Malaysia
- GMP technical service – Bioprocess Research Centre; Site location: Johor, Malaysia
- HVAC System & Cleanroom Qualification– New Biopharmaceutical Facility; Site location: Thailand
Validation Engineer (Pharma)
B. Braun Medical Industries Sdn. Bhd.
02.2015 - 01.2017
- As Subject Matter Expert (SME) for sterilizers and packaging equipment validation.
- To coordinate/ Support Head of Validation Team in the execution of Qualification and Validation in compliance to regulatory requirements by/with/as in maintaining the Master Validation Plan and update of Validation Program and preparation and maintenance of qualifications and validations procedures and documents especially for process equipment.
- Acts as the key member in Pharma Process Risk Analysis Team.
- Also, responsible as the Coordinator/ Trainer with respect to Pharma validation / qualification training needs, supporting production in trial/ test runs for production machines/ process to establish process parameter, support production projects as key member in Projects Management.
- Also, responsible as change control Coordinator and coordinate and assist in qualification and validation activities involving projects for Asia Pacific region.
- Also, responsible in heading the Validation Team in the execution of Qualification and Validation in compliance to regulatory requirements in Pharma Plant, Project Manager for Pharma Projects and perform performance of supplier qualification audit and internal audit.
- PROJECT EXPERIENCE
- Process Equipment Qualification; B Braun Pharmaceutical Expansion Facility; Site location: Penang, Malaysia
Compliance Executive (QA)
Peritone Health Sdn. Bhd.
10.2014 - 02.2015
- To establish and maintain quality documentation as according to QMS and regulatory requirement and involve in greenfield project management.
- To analyse existing documentation processes and develop recommendations for changes to working methods that will include productivity and improve compliance and consistency.
- To acts as a deputy for the Quality Manager during his absence for the smooth running and continuity of the department.
- PROJECT EXPERIENCE
- New Pharmaceutical Facility; Site location: Kedah, Malaysia
QA/QC Executive
Y.S.P. Industries (M) Sdn. Bhd.
11.2011 - 10.2014
- To establish and maintain quality documentation as according to QMS and regulatory requirement and involve in greenfield project management.
- Responsible for review Q&V documentation for existing facility (OSD) and new start up facility (SVP).
- Responsible for calibration and verification Management.
- Responsible for qualification of material source program.
- Assist in Batch Manufacturing Record (BMR) review.
- Assist in Processes Quality Control (IPQC) Program.
- Assist in final inspection of finished products.
- As a member of internal audit.
- Responsible for raw material quality control.
- Assist in packaging material quality control.
- Assist in stability study management.
- Assist in SIR, OOS and product complaint investigation.
- Involve in vendor audit and as team member of internal audit.
- PROJECT EXPERIENCE
- Facility qualification; New Small Volume Parenteral (SVP) Facility; Site location: Selangor, Malaysia
Validation Trainee
Royce Pharma (M) Sdn. Bhd.
07.2011 - 10.2011
- Responsible to develop and execute Validation Plan and maintain the Site Validation Master Plan.
- Lead a team of QA Operators for in-process Quality Control (IPQC) to ensure that the product quality meets its pre-determined out-going quality requirements.
- Responsible for QA/QC department calibration and maintenance of all inspection and test equipment.
- To support the regulatory compliance audit, customer audit and internal quality audit.
Education
Bachelor of Science - Biology
University Science Malaysia (USM)
Penang 06.2007 - 08.2010
Master of Science - Biomedical Engineering
University Malaya
Kuala Lumpur 10.2017 - Current
Skills
CSV / CSA
Additional Information
1. Marlon A. Viado
Cloud Tech Support Manager,
Accenture Solutions Sdn. Bhd,
H/P: +60192450907
2. Zarina Noordin
Ex Quality Director,
Rieckermann Engineering Operations Sdn. Bhd.
H/P: 012-326 9191
Timeline
Validation Consultant
Accenture Solutions Sdn. Bhd.
02.2020 - Current
Validation Specialist
Rieckermann Engineering Operation Sdn. Bhd.
02.2018 - 01.2020
Master of Science - Biomedical Engineering
University Malaya
10.2017 - Current
Validation Engineer
Nova Pharma Solutions Sdn. Bhd. (NNE Pharmaplan)
02.2017 - 02.2018
Validation Engineer (Pharma)
B. Braun Medical Industries Sdn. Bhd.
02.2015 - 01.2017
Compliance Executive (QA)
Peritone Health Sdn. Bhd.
10.2014 - 02.2015
QA/QC Executive
Y.S.P. Industries (M) Sdn. Bhd.
11.2011 - 10.2014
Validation Trainee
Royce Pharma (M) Sdn. Bhd.
07.2011 - 10.2011
Bachelor of Science - Biology
University Science Malaysia (USM)
06.2007 - 08.2010
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