Mutiara Ramrika
QC Supervisor
Bogor
Summary
QC Supervisor leading QC sample control, cleanroom monitoring, and water system oversight with a focus on GMP compliance and reliable release flow. Coordinates team schedules, and supports SOP development.
Strengthens testing consistency through routine trending, method validation, and controlled end-to-end sample reporting.
Assigned to the compliance department, holding a GMP Auditor training certification and serving as a lead auditor for both internal and external audits.
Overview
20
20
years of professional experience
Work History
QC Supervisor
PT. Kalbio Global Medika
02.2016 - Current
- Develop new Standard Operating Procedure (SOP) and flow process in QC and GMP aspects.
- Monitoring and controlling environmental and water system.
- Determine flow process in QC. Receive sample from beginning until end process and report. Implement GMP and building GMP habits in QC. Support sample in QC using ORACLE system.
- Routine monitoring in QC is performed and trending monthly.
- Executed routine and project monitoring according to schedule.
- Evaluated team performance regularly, providing constructive feedback and coaching for continuous skill improvement.
- Supervised and directed quality control personnel through effective mentoring, coaching and work delegation.
- Managed quality audit documentation to ensure compliance and maintain thorough records.
- Facilitated process improvements through root cause analyses of non-conformances and implementation of corrective actions.
- Office Base : Cikarang, Bekasi
R&D Analytical Development Analyst
PT. Kalbe Farma Tbk.
10.2008 - 01.2016
- Performed Analytical Method Validation to new sample and existing sample. Performed routine testing, stability testing.
- Performed routine microbiology testing such as: Growth promotion test (GPT), Sterility, endotoxin, antimicrobial effectiveness, potency of antibiotics, identification of microbe, etc.
- Participate in Continuous Improvement, Kualima, 5S, Total Productive Maintenance (TPM)
- All new sample and existing sample validated and testing during period time of testing.
- All sample (routine and stability sample) testing within period time and acceptance criteria.
- Participate into Continuous Improvement and implementation of 5S, TPM in company.
- Improving ability in the microbiology testing. The variety samples in R&D department makes analysis and problem solving skills better.
- Think critically in solving problems and how to work effectively.
- Increase ability to divide work based on level of urgency.
- Participated in continuous improvement increase the ability to think, solve, act and make decision when going through problems.
- Office Base : Cikarang, Bekasi
QC Analyst
PT. Dua Kuda Indonesia
08.2008 - 09.2008
- Performing testing raw material, intermediate material and finish good material.
- All raw material, intermediate material and finish good material released.
- Since this is my first experience working, I learned to adapt with the job and work in team. Understanding production flow process and duties of QC.
- Office Base : Jakarta Utara
Student Internship
PT. Bintang Toedjoe
01.2007 - 06.2007
- Understanding to know the flow process of QC samples, started from raw material, stability study, development study, finish good and in process control (IPC). Understanding to use laboratory instrument and adapted with the working environment.
- Office Base : Pulo Mas, Jakarta Pusat
Education
Bachelor - Industrial Engineering
President University
Cikarang, Indonesia01-2016
Chemical Analyst High School - Chemical analysis
Caraka Nusantara Chemical Analyst High School
East Jakarta, Indonesia01-2008
Skills
- Leadership
- Quality Management System (QMS)
- Halal assurance system
- GMP Auditor
- Continuous improvement
- 5S
- Microbiology testing
- Document control
- Batch record review
- CAPA management
- Deviation investigation
- Root cause analysis
- Change control
- Analytical method validation
- Environmental monitoring
- Water system monitoring
Interests
Swimming and travelling, I like the beach and challenge of travelling Sewing, design and also watching Korean drama in my spare time
Informal Education
- Microbiology training at PT Kalbe Farma Tbk (2014-2015)
- Microbiology training “The important of QC Microbiology In Pharmaceutical Industry: growth Promotion Testing and Antimicrobial Effectiveness Testing” (2014).
- Microbiology training “Endotoxin Detection Test, Best Practice “(Gel clot and Chromogenic Method)” (2016).
- Microbiology training “Achieving Excellence in Performing Method Validation as Your Foundation to Great Result” (2016).
- Cleanroom Behavior Course by ISPE Malaysia Affiliate (2017)
- Sterility xChange Forum Production and Release of Sterile Product in Singapore (2018).
- Quality System Concept Training (2018)
- Handling OOX result training by ISPE Indonesia Affiliate (2019).
- One Step Ahead of Microbiology (2019).
- People Effectiveness Program (PEP) (2019).
- Halal Assurance System (2020 and 2026).
- Root Cause Analysis Training (2020).
- Lean Six Sigma Workshop - Yellow Belt (2020).
- GMP Auditor Training (2021).
- Benefits & Risk Based Approach in the Implementation of LIMS (2021).
- Data Integrity Implementation Road Map (2021).
- Compliance with the latest EU GMP (Annex 1) (2023).
- Pharmaceutical Water Systems (T35) by ISPE Singapore Affiliate (2025).
Timeline
QC Supervisor
PT. Kalbio Global Medika
02.2016 - Current
R&D Analytical Development Analyst
PT. Kalbe Farma Tbk.
10.2008 - 01.2016
QC Analyst
PT. Dua Kuda Indonesia
08.2008 - 09.2008
Student Internship
PT. Bintang Toedjoe
01.2007 - 06.2007
Chemical Analyst High School - Chemical analysis
Caraka Nusantara Chemical Analyst High School
Bachelor - Industrial Engineering
President University