Ahmad Sharqowi bin Rohaimi
Senior Executive, Production (Compliance)
Johor Bahru
Summary
Highly experienced and knowledgeable production executive with over 11 years of experience in pharmaceutical, food, and medical device industry. Possessing expertise in managing complex production issues, team leadership, and continuous improvement initiatives. Well verse on the cGMP compliance aspect in production with full dedication to maintain high quality standards. Committed to achieving organizational goals while continually improving performance and delivering value to all stakeholders.
Overview
13
13
years of professional experience
3
3
years of post-secondary education
2
2
Languages
Work History
Senior Executice Production
Biocon. Sdn Bhd
Nusajaya
04.2021 - Current
- Ensure production compliance to cGMP and Data Integrity during daily production process
- Conduct regular gemba walk and inspection of production areas to evaluate areas for improvement
- Managed daily production schedule and production planning
- Review of production documents (batch manufaturing record, logbooks)
- Established and review of production procedure (SOP, EOP, BMR) and contribute to the continuous improvement of the system
- Skilled in Quality Management System aspect (non conformance, CAPA, Change Control, Risk Assessment, etc)
- Developed and enforced work procedures to ensure compliance with regulations and standards
- Collaborated with cross functional teams to optimize production process and exceed quality standards
- Ensure production equipment are calibrated and maintained as per schedule
- Assist in the execution of equipment qualification and re-qualification
- Responsible for building management system for all productio area
- Cultivated interpersonal skills by building positive relationships with others.
- Skilled at working independently and collaboratively in a team environment.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Managed time efficiently in order to complete all tasks within deadlines.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
Executive, Production
Biocon Sdn Bhd
Nusajaya
04.2017 - 03.2021
- Execute production downstream process to meet business target
- Managing production schedule and planning
- Preparation and review of production related document (SOP, EOP, BMR, etc)
- Maintained machinery to prevent overloads and avoid malfunctions.
- Supported machine operators in setup and operation of production equipment resulting in efficient runs.
- Organized work to meet demanding production goals.
- Troubleshot production issues and provided timely solutions.
- Participated in regular meetings with team members to discuss production updates.
- Implemented company policies, technical procedures and standards for preserving integrity and security of data, reports, and access.
- Took on additional shifts during peak work periods to keep projects on schedule.
- Resolved issues quickly to maintain productivity goals.
- Volunteered for additional assignments during peak work periods to keep tasks on schedule.
- Inspected and adjusted work performed to meet expectations.
- Used equipment properly to avoid workplace hazards or injuries.
- Followed safety procedures and guidelines to maintain safe working environments.
- Collaborated with back-office team members to facilitate seamless business execution.
Team Leader, Quality Assurance
A&S Global Food
Bandar Baru Bangi
11.2015 - 07.2016
- Established SOP for production activity and quality assurance
- Organize and control all business related operational activity (process, documentatio )
- Monitor daily performance of production line
- Vendor management
Senior Executive
Glaxosmithkline Sdn Bhd
Selangor
03.2014 - 11.2015
- Analyzed quality and performance data to support operational decision-making.
- Coordinate and supervise quality control laboratory activities focusing on incoming material receipt, sampling, testing and approval for production use
- Conduct regular internal audit in the company
- Conduct regular vendor external audit as part of vendor management
- Reduced the back log of incoming material isnpection and rewarded for Zero Hero Award
- Collaborate with other department (SCM, Warehouse, QA) to ensure timely approval or material for production use
Laboratory Analyst
Ciba Vision Sdn Bhd
Johor
11.2009 - 11.2013
- Analyzed product and environmental for its microbial load
- Involve in OOT/OOS investigation
- Execution of equipment qualification and re-qualificatio
- Managing of laboratory inventories, maintenance and calibration of laboratory equipment
- Supervise and training of laboratory operator
- Site trainer for bioburden control topic
Education
Bachelor Of Science - Biotechnology Industry
Selangor Industrial University
Selangor, Malaysia 07.2006 - 10.2009
Skills
Proficiency in cGMP and Quality Management System
undefinedAccomplishments
- Achieved reduced documentation error in batch record by document simplification activity
- Achieved standard time recording by implementation of GPS clock in production area
- Succesfull USFDA certification for Insulin Glargine
- Involved in regulatory audit (EMA, HPRA, ANVISA, etc)
Timeline
Senior Executice Production
Biocon. Sdn Bhd
04.2021 - Current
Executive, Production
Biocon Sdn Bhd
04.2017 - 03.2021
Team Leader, Quality Assurance
A&S Global Food
11.2015 - 07.2016
Senior Executive
Glaxosmithkline Sdn Bhd
03.2014 - 11.2015
Laboratory Analyst
Ciba Vision Sdn Bhd
11.2009 - 11.2013
Bachelor Of Science - Biotechnology Industry
Selangor Industrial University
07.2006 - 10.2009
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