LINA FILZAH ISMAIL
Quality Assurance QMS Executive
Johor Bahru
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
12
12
years of professional experience
3
3
years of post-secondary education
2
2
Languages
Work History
QUALITY ASSURANCE – QUALITY MANAGEMENT SYSTEM
BIOCON SDN. BHD.
10.2023 - Current
- Review of Quality Management system with respect to CAPA and deviation investigations.
- Periodic tracking and follow up of the CAPA and deviation closure to meet site KPI.
- Prepare periodic trend data for CAPA and deviation and its evaluation for monthly and quarterly review board meeting.
- Collaborated with cross-functional teams to establish quality objectives and ensure alignment with organizational goals.
- Involve in regulatory audit preparation (CAPA binder preparation, audit room readiness).
- Participated in regulatory audit and actively coordinate with war room/back room team to provide prompt response to auditor.
- Involve in internal audit and routine inspection walk to identify areas for improvement, resulting in higher levels of efficiency and effectiveness within the organization.
- Review of periodic quality report with respect to CAPA and deviation.
PRODUCTION DRUG PRODUCT – PACKAGING / COMPLIANCE
BIOCON SDN. BHD.
05.2018 - 09.2023
- Managed multiple tasks simultaneously (document submission for CAPA and CC closure, periodic SOP and EOP review, documents archival, cGMP audit readiness, new employee training, batch records review fro batch release), prioritizing tasks effectively to meet tight deadlines without compromising quality.
- Coordinate with QA for internal audits and routine inspection walk. To ensure audit / inspection reports are closed in timely manner.
- Support HSE team to update first aid kit in packaging area, and to report any potential safety concern across site.
PRODUCTION CONTROL (PLANNER)
SHACHIHATA (M) SDN. BHD.
06.2017 - 04.2018
- Coordinate with CFT for manpower resources, injection moulding schedule, packaging configuration, material and product testings, and finished product adequacy for vessel arrangement
- Scheduled visit to sub-contractor site for material supply follow up and stock take
- Planning of upcoming months’ of material usage to ensure uninterrupted production operation.
PRODUCTION ASST. ENGINEER
PLASTRADE GROUP OF COMPANIES
12.2012 - 05.2017
- Conduct relevant testing on incoming material and in-process polymer compound
- Collection of chemically-treated polymer compound sample for finished product testing
- Conduct monthly stock check for additives and packaging materials
- Planning of packaging materials consumption and daily consumables, and submission of finalized quantity to logistic department for procurement
- Review and receipt of consignment notes for incoming materials and empty vessels for FP shipment
- Preparation of production report for monthly company review.
Education
Bachelor’s Degree of Science (Hons.) in Industrial Chemistry -
UNIVERSITI TEKNOLOGI MALAYSIA
07.2009 - 05.2012
Skills
Quality Systems Analysis
Quality Management
Standard Operating Procedures
Corrective Actions
Preventive Actions
Internal Auditing
Document Control
Task Prioritization
Accomplishments
- Promoted from Senior Associate level to Assistant Manager (2021).
- Quarterly commendation by the company on collaborative contribution to reduce the number of overdue QMS records in the department (market complaint, CAPA and CC).
Timeline
QUALITY ASSURANCE – QUALITY MANAGEMENT SYSTEM
BIOCON SDN. BHD.
10.2023 - Current
PRODUCTION DRUG PRODUCT – PACKAGING / COMPLIANCE
BIOCON SDN. BHD.
05.2018 - 09.2023
PRODUCTION CONTROL (PLANNER)
SHACHIHATA (M) SDN. BHD.
06.2017 - 04.2018
PRODUCTION ASST. ENGINEER
PLASTRADE GROUP OF COMPANIES
12.2012 - 05.2017
Bachelor’s Degree of Science (Hons.) in Industrial Chemistry -
UNIVERSITI TEKNOLOGI MALAYSIA
07.2009 - 05.2012
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