Muhammad Ruzaini Bin Ghazali
Summary
Passionate individual with 9 years of Pharmaceutical and Biologics manufacturing experience. Proficient in current regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgement and sound critical thinking and problem-solving abilities.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Biotechnologist
Lonza Biologics Tuas
03.2017 - Current
- Advanced to the role of Deputy Lead
- Actively participate in change control, validation, process development, tech transfer and deviation investigations with other functions.
- Responsible for recommendation and implementation of CAPAs and effectiveness checks.
- Conducts monthly 6S, Gemba and EHS inspections with relevant stakegholders
- Competent in reviewing of documents whilst ensuring accuracy and compliance to cGMP and GDP standards.
- Executes effective planning in scheduling human and material resources within team and carries out operations within established budget.
- Responsible for deviations write ups to ensure timely batch release of final product.
- Responsible in ensuring and maintaining good condition of GMP Facility, cleanroom, and associated manufacturing equipment.
- Responsible in maintaining oversight and control on non-production activities as area owners.
- Successfully developed and revised comprehensive manufacturing operations related SOPs and safety risk assessments and adhere to all environment, health, and safety (EHS) guidelines.
- Played key role in developing, mentoring and training of junior colleagues.
- Successfully created and implemented effective multiple continuous improvement projects that generated savings in terms of manpower and revenue.
- Responsible for driving operations excellences and key operations targets, and drive safety improvements and initiatives across team.
- Volunteered commitment as Site Incident Controller for site Emergency Response.
- Volunteered commitment as department's EHS representative.
Process Technician (Compounding)
Alcon Singapore Manufacturing
03.2015 - 11.2016
- Executed successful manufacturing of ophthalmic solutions in cGMP environment and performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Followed all waste handling guidelines to minimize waste generation.
- Played key role in developing, implementing and documenting of manufacturing processes.
- Improved workflow operations and created more time for batch record reviews.
- Coordinated multi-disciplinary team from various departments and levels to successfully investigate, troubleshoot and solve complex process deviations.
- Successfully created and revised SOPs for manufacturing processes.
- Appointed as main personnel to continually review manufacturing batch records to ensure quality assurance.
- Served as member of Emergency Response Team.
- Served as member of WSH Committee.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Maintained energy and enthusiasm in fast-paced environment.
- Proven ability to learn quickly and adapt to new situations.
Facilities & Safety Officer
A*STAR
05.2013 - 03.2015
- Manages safe building operations and facility related matters to optimize building operation and energy saving.
- Played key role in implementation, monitoring and continual improvement of HSE Management System, planning for emergency response plans and business continuity plan.
- Manages hazardous chemical/biological inventory and regulation of wastes.
- Improved workflow for new staffs/contractors to be trained with current safety induction trainings.
- Lead identification, assessment and management of health, safety and environmental risks.
- Experienced in writing tender specifications for services and equipments.
- Maintained physical condition of facilities, applying available resources and personnel to achieve safe, clean, and functional environment
- Directed vendors, facilities staff, and service providers as required to create efficient and non-disruptive work environment
- Enforced compliance with applicable health, safety and environmental regulations to reduce risks
- Oversaw annual budget to handle supply, labor and maintenance needs
- Served as point of contact for internal and external customers seeking support and information
Technical Executive
Nanyang Technological University
11.2010 - 04.2013
- Manages operations of laboratories that includes planning for laboratory consumables, preventive maintenance of equipments and yearly budgeting.
- Supports Principal Investigators and Lead Scientists with equipment operations.
- Played key role in conducting laboratory experiments training to faculty members and students.
- Experienced in writing tender specifications for services and equipments.
- Developed and manages hazardous chemical and biological inventory and wastes system.
- Inspected laboratory equipment to maintain good working condition for optimal results.
- Troubleshot and resolved equipment and process issues.
- Conducted regular safety inspections and audits to identify potential hazards and prevent accidents and injuries.
- Coordinated emergency response plans and drills to increase preparedness and address issues promptly.
- Served as member of Emergency Response Team.
Education
Bachelor of Science - Human Factors in Safety
Singapore University of Social Sciences
Singapore03.2018
Diploma - Biomedical Engineering
Republic Polytechnic
Singapore03.2008
Skills
- Data Verification
- Impact Assessment
- Technical Guidance
- Forms Management
- Inspections
- Risk Management
- Audits
- Change Control
- Cross-Functional Collaboration
- Time Management
- Technical Writing
- CAPA Management
Certification
- Advanced Fermentation Process
- Advanced Harvest Process
- Bioprocessing Upstream/Downstream
- Certified Workplace Safety Coordinator
- Advanced FIT
- Relationship Management
- Conflict Management
Languages
English
Bilingual or Proficient (C2)
Malay
Bilingual or Proficient (C2)
Timeline
Biotechnologist
Lonza Biologics Tuas
03.2017 - Current
Process Technician (Compounding)
Alcon Singapore Manufacturing
03.2015 - 11.2016
Facilities & Safety Officer
A*STAR
05.2013 - 03.2015
Technical Executive
Nanyang Technological University
11.2010 - 04.2013
Bachelor of Science - Human Factors in Safety
Singapore University of Social Sciences
Diploma - Biomedical Engineering
Republic Polytechnic
Similar Profiles
Pablo García JoanidopoulosPablo García Joanidopoulos
Bioprocess Engineer at Lonza BiologicsBioprocess Engineer at Lonza Biologics
Carter RoweCarter Rowe
Logistics Specialist Level 3 at Lonza BiologicsLogistics Specialist Level 3 at Lonza Biologics
Michael CondellaMichael Condella
Biotechnologist at Lonza BiologicsBiotechnologist at Lonza Biologics