Tiwi Anggraini
Head Of Operation
Bekasi,West Java
Summary
- More than 11 years experiences in Quality Assurance, Quality Control, Validation/Qualification Project management, Production, Planning Inventory and Warehousing within Pharmaceuticals Industry and Plastic Recycle Industry.
- Good working knowledge of Quality System (Quality Assurance and Quality Control) and Manufacturing Operations.
- Good technical writing and verbal communication skills in English.
- Good organization skills.
- Strong analytical, numerical, and reasoning skills.
- Able to effectively summarize findings and draw conclusions, considering interfaces/links between quality processes.
- Detail oriented, self-motivated, strong interpersonal and communication skills.
- Able to work individually and in teams.
- Strong skills in Quality Assurance, Production, Laboratory Analysis, Planning Inventory and Warehousing, cGMP projects management include Technical Transfer, Process Validation, Analytical Method Validation, and Equipment/Machine/Facility Qualification.
- Able to handle a multitude of assignment in strict deadlines.
- Computer literate with PC. Knowledge with Microsoft Office (Word, Excel, Power Point, Outlook, Visio), Chemdraw, Corel Draw, Adobe Acrobat, Adobe Photoshop, Canva.
Overview
12
12
years of professional experience
11
11
Certifications
2
2
Languages
Work History
Head of Operation
PT Amandina Bumi Nusantara
08.2023 - Current
- Company Overview: JV between Coca Cola Europacific & Dynapack Asia
- Manage Production and Maintenance Departments
- Ensure operation teams can work together to achieve company goals
- JV between Coca Cola Europacific & Dynapack Asia
- Successfully reduce cost and minimize loss from pelletizer line to below 1% and reduce unplanned downtime
- Increase output 36% for Hot Washed Flakes
- Increase accuracy of spare parts availability
Production Manager
PT Amandina Bumi Nusantara
05.2023 - 07.2023
- Company Overview: JV between Coca Cola Europacific & Dynapack Asia
- Manage Production and QC & QHSE Departments
- Responsible for ensuring that operational activities are carried out in accordance with quality, Halal, and safety requirements
- Responsible to improve output, yield, and quality in operation area
- Improve production department, coordinate the teams to investigate any issues in the operation area, especially on the machine and if there are any non-conformance issues
- Evaluate and analyze quality issues in the production and how to improve it or minimize the risks
- Responsible to develop all teams, i.e
- Operators, staffs, supervisors, to understanding the machine or instruments, and the processes
- Responsible to optimize cost saving and energy reduction
- Ensure operation teams can work together to achieve company goals
- JV between Coca Cola Europacific & Dynapack Asia
- Successfully reduce downtime, increase the OEE & yield through continuous people developments
- Achieve highest output (quantity and quality) for 3 consecutive months compare to previous period
- Exceed OEE limit and achieve all KPI in Production and QC & QHSE Departments
QC & QHSE Manager
PT Amandina Bumi Nusantara
02.2023 - 04.2023
- Company Overview: JV between Coca Cola Europacific & Dynapack Asia
- Manage QC & QHSE Department
- Responsible for ensuring that operational activities are carried out in accordance with quality requirements of ISO 9001 and FSSC 22000
- Review, develop and manage all QC & QHSE standards, policies, and systems
- Ensuring compliance with all certifications to Maintain and manage external accreditation (including OU Coca Cola Euro Pacific, SGP, Halal, EFSA, FDA, REACH, and local FDA, Indonesian National Standard, Eco Label)
- Maintain the internal QHSE audit programs against all relevant standards and complete inspections and audits as required and ensure compliance to both internal and external standards
- Control the day-to-day operations including auditing, meetings, training and updating documents and record for all aspects of the systems
- Evaluate and analyze quality issues in the production and introduce corrective and preventive actions
- Handle customer complaints
- Liaise with management and staff to ensure continued QHSE integration into core operations
- Monitor and ensure that all Quality, Health & Safety and Environmental legislation is complied with and ensure a safe working environment for all team members within a busy manufacturing and service environment
- Manage company Safety file
- Conduct continuous improvement processes to improve processes and procedures
- JV between Coca Cola Europacific & Dynapack Asia
- Successfully get certificate for OU, SGP, Eco Label, and Indonesian National Standard
Quality Control Manager
PT Amandina Bumi Nusantara
03.2022 - 02.2023
- Company Overview: JV between Coca Cola Europacific & Dynapack Asia
- Manage QC teams (QC Incoming Material & QC Finish Goods) i.e
- Manage resources, recruitment, weekly internal meeting, setting challenging goals in line with the company directives, performance of regular reviews and development plant
- Create and manage Quality System implementation related to product quality (non-conformance report, standard operating procedure, working instruction, analytical method validation)
- Coordinated the investigation and closure of nonconformance with specific emphasis on comprehensive root cause analysis
- Ensured initiation, implementation of appropriate CAPA
- Prepared and participated in internal & external audit (ISO, SGP, local FDA, OU audit)
- Planning, documenting, and ensure all testing result and bales audit are performed accurate & successfully completed according to the timeline
- Perform supplier qualification, handling material complaint
- Budgeting for QC Department
- Review quality of finished product and make disposition
- Supervise production process of the wash line & extrusion lines
- Makes disposition if there are any issues related to product quality during production process
- Manage planning and execution of internal and external calibration
- Give training from internal procedure to all employees QC members
- Review analytical result from QC department, make decision of all products (releasing or rejecting it)
- Introduce and develop ISO 9001: 2015 in the QC department
- JV between Coca Cola Europacific & Dynapack Asia
- Involved as QC representative and finished OU audits (initial certification related to SGP audit) with a good result
- Successfully develop all testing method for the new plant of PET recycle within 2 months
- Successfully pass all requirements from major customer in 3 months after first production trial and continue to commercial production
Quality Assurance Supervisor
PT CKD OTTO Pharmaceuticals
07.2017 - 02.2022
- Ensuring all production processes are compliant with Good Manufacturing Practice (GMP)
- Communicate with, coach, and coordinate with QA teams and other departments
- Monitor the performance of Quality Assurance team to ensure its effectiveness and efficiency
- Create and manage Quality System implementation (deviation, CAPA, change management, and data integrity)
- Control the circulation of GMP documents in the company (document control)
- Develop documents related to regulatory compliances / quality system / QA standard (standard operating procedure, working instruction, policy)
- Monitor and ensure the quality management system & regulatory compliances to be consistently implemented and well maintained
- Create Quality Risk Assessment, review dossier document for new products
- Planning, documenting, and ensure qualification (building, facility, machine) and validation activities (process, analytical method, filtration, cleaning) successfully according to the timeline
- Responsible to total management systems implementation: GMP, Halal
- Handle audits (internal & external - customer, Indonesian and abroad certification body, government authority)
- Active involvement in the innovation process to ensure quality is delivered by design
- Handle vendor & supplier qualification
- Forecasts, prepares and monitors the operating, personnel and capital expenses budgets in Quality Assurance Department
- Review completeness of batch record, raise deviation if there is any non-conformity, make disposition to finished product
- Review dossiers for all products (new and existing products), prepare supporting documents for product registration
- Supervise process validation for new drugs (sterile injection liquid and lyophilized injection)
- Handle technical transfer (manufacturing process from sending unit to receiving unit)
- Manage planning and execution of internal and external calibration
- Scheduling and give GMP Internal Training to all employees
- Review analytical result from QC, manage stability testing for new products
- Ensure the analysis of intermediate products, bulk products, finished products, and in process control goes well through QC's analytical result and the result are correct
- Ensure of raw materials, packaging materials, intermediate products, bulk products, finished products and in process control
- Involved as an auditee in toll manufacturing audit
- Involved as Document Control (member of Halal Team) and an auditee in Halal re-certification
- Involved as Document Control (member of Halal Team) and an auditee in obtaining Halal certificate within 3 weeks after registration
- Involved as an auditee in obtaining GMP certificate and successfully get GMP certificate within 2 months after the BPOM audit
- Successfully reduce number of samples for validation testing, stability testing, and retain sample
Validation Engineer
PT Ethica Industri Farmasi Joint Venture with Fresenius Kabi
10.2015 - 07.2017
- Lead validation team
- Planning, documenting, and reporting validation & qualification activities according to timeline
- Coordinate with other departments during validation and qualification activities
- Create Validation Plan and validation standard operating qualification activities
- Supervise process validation for new drugs (sterile injection liquid)
Specialist, Validation
PT Ferron Par Pharmaceuticals
02.2013 - 05.2015
- Lead process validation team
- Supervise process validation for new and existing drugs (sterile injection liquid, lyophilized injection, solid, oral liquid, semisolid)
- Handling OOS in laboratory and deviation during process validation
- Review result of analysis from QC department (chemical, physical, and microbiological) of all process validation products
- Check testing method, manufacturing instruction, and product specification related to process validation based on compendial and or other references
- Successfully completed process validation for 33 products with enlargement batch size in sterile line 3 (new injection line within 1 and half years)
Education
Pharmacist -
Sanata Dharma University
02.2012 - 1 2013
Bachelor of Pharmacy - undefined
Sanata Dharma University
08.2007 - 11 2011
Skills
Spectrophotometer UV-Vis
Spectrophotometer Colorimetry
Atomic Absorption Spectrophotometer
Gas Chromatograph Mass Spectroscopy
Kaye Validator
LMFI tester
Flakes Scanner
Differential Scanning Calorimetry
Washline Machine for recycled PET Flakes
Pelletization Machine for recycled PET Resin
High Performance Liquid Chromatograph
Thin Layer Chromatograph
Decisiveness
Good communication
Ability to mentor
Manage team members
Analysis
Logical reasoning
Problem solving
Time management
Observant
Organized
Responsible
Open-mindedness
Certification
Awareness Training FSSC 22000 V 5.1, ISO 9001:2015 & ISO 22000:2018, Kualita Sinergi, 05/01/22
Personal Information
Date of Birth: 12/18/88
Educations
- Apotechary Programs, Sanata Dharma University, 02/01/12, 01/31/13
- Bachelor of Pharmacy, Sanata Dharma University, 08/01/07, 11/30/11
References
- Colin Broom, Technical Expert at Circular Plastic Australia (PET), previously Head of Operation at PT. Amandina Bumi Nusantara, colinbroom@gmail.com
- Irawati Raharjo, Quality Assurance Manager at PT Brightgene Biomedical Indonesia, Former Manager at PT CKD OTTO Pharmaceuticals, +62815-6952-866
- Rejeki Indiastuti, Quality Manager at PT Fonko International, Former manager at PT Ferron Par Pharmaceuticals, +62821-2383-2201
- Budi Yuwono, Factory Manager at PT Ferron Par Pharmaceuticals, Former indirect manager at PT Ferron Par Pharmaceuticals, +62815-6876-904
Timeline
Head of Operation
PT Amandina Bumi Nusantara
08.2023 - Current
Production Manager
PT Amandina Bumi Nusantara
05.2023 - 07.2023
QC & QHSE Manager
PT Amandina Bumi Nusantara
02.2023 - 04.2023
Quality Control Manager
PT Amandina Bumi Nusantara
03.2022 - 02.2023
Quality Assurance Supervisor
PT CKD OTTO Pharmaceuticals
07.2017 - 02.2022
Validation Engineer
PT Ethica Industri Farmasi Joint Venture with Fresenius Kabi
10.2015 - 07.2017
Specialist, Validation
PT Ferron Par Pharmaceuticals
02.2013 - 05.2015
Pharmacist -
Sanata Dharma University
02.2012 - 1 2013
Bachelor of Pharmacy - undefined
Sanata Dharma University
08.2007 - 11 2011