Yulia Puspitasari

Yulia Puspitasari

Education

Education
2014 - Present

Master Degree program in Pharmaceutical Manufacturing Technology

Trinity College Dublin, Ireland
2004 - 2005

Pharmacist Profession Program

Airlangga university, Indonesia
1999 - 2004

Bachelor Degree of Pharmacy

Airlangga University, Indonesia

Work History

Work History
Jan 2015 - Present

Senior Validation Engineer

PSC Biotech Pte. Ltd, Singapore
Jun 2008 - Dec 2014

Project Leader (Non Sterile and Sterile Products)and Pharmaceutical Formulation Scientist

Kotra Pharma (M) Sdn Bhd, Malaysia
Jan 2007 - Jun 2008

Quality Control of Starting Materials, Finished Good and Stability

PT. Bristol-Myers Squibb Tbk, Indonesia
Aug 2005 - Jan 2007

Chemical Laboratory Supervisor

PT. Daria Varia Laboratoria Tbk, Indonesia
Mar 2005 - Aug 2005

Quality Control Supervisor

PT. Sanbe Farma, Indonesia

Summary

Experienced in Quality Control departement which including :

  • Coordinator of Process Validation and Cleaning Validation, including : Preparation of Validation documents (Validation Master Plan, Validation Protocol and Validation Report), coordinate validation execution, ensure the completeness and compliance of validation activities, responsible for ensuring that the manufacturing site is prepared for Drug Authority pre-approval inspections for validation, responsible for the achievement of validation yearly objectives.
  • Responsible on the compliance and support quality as well as production activities to meet regulatory and company expectation.
  • Coordinator of Starting Material Release (Raw material and Packaging material) and Product Release.
  • Responsible on the review process of batch records (Batch Manufacturing Record, Batch Filling Record and Batch Packing Record).
  • Active in GMP Audit activities, both for Internal Audit and External Audit. Also as a member of Audit Team during HALAL Audit by MUI and JAKIM. Preparing CAPAs of the findings.
  • As an investigator of any deviations which was happened in Production Area and other areas, which may give any impacts to the product quality. Prepare investigation report, risk assessment and justification. Also review Deviation Change Notice.
  • Responsible on the handling, preparation and documentation related with quality system, including Change Control Management, Annual Product Review, Product Complaints, Risk assessment, Investigation and others.

Experienced in handling and supervise Quality Control Department both in Local and Multinational Companies, which including :

  • Responsible to the managing of chemical and microbiological testing for Starting material, In Process Control, Finished Product, Stability samples, and samples from product complaints.
  • Responsible on performing investigation of the Out of Trend and Out of Specification results. Take responsibility as a “Quality Control Manager” in the Trackwise system.
  • Responsible on the managing budget of Quality Control Department.
  • Coordinator of Analytical Method Validation and Equipment qualification.
  • Coordinator of Qualification and Calibration for the instruments in laboratory.
  • Support Process Validation and Cleaning Validation activities
  • Stability Studies Program Coordinator.

Experienced in Research and Development Department, which including :

  • Responsible to the new product development, for Ethical and OTC Products, for Sterile and Non Sterile Product.
  • Responsible to the development of generic products which is required to be Bio Equivalent with the innovator.
  • Responsible on handling Technology Transfer.
  • Responsible on API and excipients sourcing and qualification, including supplier qualification.
  • Stability Studies Coordinator.
  • Coordinator of qualification and calibration for the instruments and machines in the laboratory and pilot plant.
  • Responsible to the dossier preparation for Asia Countries and prepare responses on the queries from DRA related with the registration submission.
  • Responsible to the Process Validation execution and Scale up.
  • Support Regulatory Department in negotiation with local Regulatory Authorities to expedite regulatory approvals.

Personal Info

Place / Date of Birth :

Mojokerto / 8 July 1981

Address : Eight Courtyards, 6 Canberra Drive #08-07 Singapore 768140

Religion : Christian

Phone No : +(65) 84373722

Marital Status : Married with 1 (one) daughter

Achievement

  • Successfully developed existing Packaging Material Vendor to support Reduced Testing Packaging Material Program.
  • Successfully managed Quality Control responsibilities to support export of Value Stream products. Awards have been given in recognition of Strong Accountability and Energizing Others, due to this achievement.
  • Lead Product Quality Improvement which indirectly delivered impact on cost reduction of manufacturing of multi-vitamins products and Antibiotics products.
  • Successfully conducted development and Bioequivalent Study of Anti hypertension products.
  • Successfully lead Technology transfer and execution of Process Validation for Anti hypertension and Anti Diabetics products from the Contract manufacturer.
  • Successfully lead Technology transfer and execution of Process Validation for supplement products.
  • Successfully reviewed and optimized sterile manufacturing process, under Supervisor Development Program, which deliver reduction manufacturing cost of Sterile Facilities.
  • Successfully investigated on the drug counterfeiting from the received sample of product complaints.

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