KHAIRUL HAFEZI MOHD KASWAN
Summary
Dynamic Production Pharmacist with a proven track record at Pharmaniaga Lifescience, enhancing production efficiency and ensuring compliance with GMP guidelines. Skilled in Trackwise and adept at root cause analysis, I excel in improving processes and mentoring teams to achieve excellence in pharmaceutical manufacturing.
Overview
6
6
years of professional experience
Work History
Production Pharmacist
Tenang Pharma Sdn Bd
Nilai
01.2024 - 06.2024
- Reviewed batch records for accuracy and completeness before releasing products for distribution, maintaining high level of accountability throughout entire process lifecycle.
- Managed team of technicians responsible for executing daily production tasks efficiently and effectively.
- Improved production efficiency by streamlining processes and implementing best practices in pharmaceutical manufacturing.
- Conducted thorough investigations into deviations or out-of-specification events, identifying root causes and implementing corrective actions to prevent recurrence.
- Reviewed batch records to ensure compliance with cGMP regulations.
- Participated in root cause analysis investigations following deviations from established standards or procedures.
Production Pharmacist
Pharmaniaga Lifescience Sdn Bhd
Puchong, 47100
5 2023 - 01.2024
- Oversees and manages production process (manufacturing and packaging) to ensure they comply with set guidelines and standards (GMP and PIC/S) prepare and check related BMR and BPR for manufactured products and SOP to ensure that the process in Production is done
- Responsible in handling routing for all products
- In charge of packing schedule to be able to ensure products are able to commit delivery on time
- Review and check batch documentation for correctness, completeness and safely archive the original document
- Ensure production process complies with GMP guidelines and to raise deviation and investigation for any OOS through eQMS using eQMS Trackwise system
- Engages with related personnel to ensure that all deviation and non-conformity reports are responded accordingly; proper investigations are done, corrective / preventive actions are raised, implemented, and strictly adhered to support regulatory inspections (NPRA and USFDA).
- In charge of raw material consumption and confirmation and good movements through ERP system (SAP)
- Supervise activities associated with dispensing and SMS areas as well as Production areas.
- Responsible to verify the potency calculation for Active Pharmaceutical Ingredients and its excipient for manufacturing based on COA.
- Participated in external audits by regulatory agencies, demonstrating a strong commitment to compliance and quality assurance practices.
Provisionally Registered Pharmacist
Pharmaniaga Lifescience
01.2022 - 01.2023
- Learnt on the overview of operations from all department involved
- Learnt on the importance of Quality Management System and on hand practice with Trackwise
- Oversees the production process and reviewing BPR and BMR to ensure the process was done correspondingly
- In charge of inventory management for Cleanroom ensuring consumables is well stocked
- In charge of Improvement projects for Newmann Labelling machine to improve its performance
- Involved in EU Audit as production auditee
- In charge of packing schedule to ensure production is able to meet delivery on time.
- Exposed to drug registration, and familiarize with pharmacovigilance activities.
Student Intern
Tengku Ampuan Rahiman Hospital
Selangor, Malaysia
01.2020 - 01.2020
- Assisted pharmacist in filling medicine in tray to be dispensed in Outpatient pharmacy
- Joined MTAC clinic conducted by pharmacist
- Assisted pharmacist in filling medication cart for inpatient.
- Reported back to instructor to receive day-to-day tasks and responsibilities.
- Communicated effectively with faculty and staff and accepted critiques and suggestions for areas of improvement.
Student Intern
Hospital Serdang, Hospital
Selangor, Malaysia
01.2020 - 01.2020
- Joined pharmacist doing ward rounds
- Reviewed and monitored patient past and present medication records, checking for errors, incompatibilities and adverse reactions to avoid future complications.
- Provided educational information sessions and programs for families, healthcare providers and community organizations.
- Reported back to instructor to receive day-to-day tasks and responsibilities.
- Assisted pharmacist in filling medication in tray to be dispensed in Outpatient pharmacy.
Pharmacy Assistant
Clinic QFFD
01.2018 - 01.2018
- Assisted the clinic staff in operating mobile clinic
- Perform basic medical checkup for patients
- Assisted pharmacy staff with drug inventory and inventory management through stock take.
Education
Bachelor - Pharmacy
University of Cyberjaya
Cyberjaya11-2022
Skills
- Training and mentoring
- Coordinating inventory
- Improving processes
- Overseeing technicians
- Trackwise Proficiency
- Root Cause Analysis
Languages
Malay
First Language
English
Advanced (C1)
C1
Timeline
Production Pharmacist
Tenang Pharma Sdn Bd
01.2024 - 06.2024
Provisionally Registered Pharmacist
Pharmaniaga Lifescience
01.2022 - 01.2023
Student Intern
Tengku Ampuan Rahiman Hospital
01.2020 - 01.2020
Student Intern
Hospital Serdang, Hospital
01.2020 - 01.2020
Pharmacy Assistant
Clinic QFFD
01.2018 - 01.2018
Production Pharmacist
Pharmaniaga Lifescience Sdn Bhd
5 2023 - 01.2024
Bachelor - Pharmacy
University of Cyberjaya
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