Experience

Promethean BioPharma Ltd

• Canada
• Biotechnology
• 1 - 100 Employee

• Quality Manager

  • Sep 2020 - May 2023

  Sydney, New South Wales, Australia • Stablish a full QMS system and related documentation for a brand-new pharmaceutical facility • Quality Management system improvement • Application and acquisition of primary packaging and manufacturing TGA licence for a pharmaceutical facility • Evaluate audit findings and implement appropriate corrective actions • Providing, updating and controlling QA documentation • Customers complain management • Improvement documentation and training for Deviation management, risk… Show more • Stablish a full QMS system and related documentation for a brand-new pharmaceutical facility • Quality Management system improvement • Application and acquisition of primary packaging and manufacturing TGA licence for a pharmaceutical facility • Evaluate audit findings and implement appropriate corrective actions • Providing, updating and controlling QA documentation • Customers complain management • Improvement documentation and training for Deviation management, risk management and change management • Assess and identify the TGA project requirements consist of clean rooms, HVAC, production’s machinery and equipment’s layout • Compare and select the suppliers and purchase the most compatible machinery • Risk assessment and control procedure • Perform technical training • TGA project requirements analysis • Pharmaceutical manufacturing line design and line set up Show less



Lipa Pharmaceuticals Limited

• Australia
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Validation and Technical Manager

  • Jun 2018 - Sep 2020

  Sydney, New South Wales, Australia • Managing the validation department • Prepare the Validation Master Plan and implement required validation for a new facility (HVAC, Cleaning, process validation IQ, OQ and draft the PQ for equipment) • eQMS installation and Implementation in charge • Non-conformance and OOS management team member • Drafting the protocol and reports • Process improvement in charge • Incident and deviation management team member (investigation, report, CAPA and follow up) • CAPEX and… Show more • Managing the validation department • Prepare the Validation Master Plan and implement required validation for a new facility (HVAC, Cleaning, process validation IQ, OQ and draft the PQ for equipment) • eQMS installation and Implementation in charge • Non-conformance and OOS management team member • Drafting the protocol and reports • Process improvement in charge • Incident and deviation management team member (investigation, report, CAPA and follow up) • CAPEX and New machinery purchasing in charge • Perform technical training Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Packaging Coordinator

  • Jun 2017 - Dec 2018

  Sydney, Australia • Effectively prioritizing to ensure that time and resources are optimized to support production • Prepare and report on key performance indicators and departmental activities • Ensuring batch documentation i.e. shop orders, forms, logbooks, is accurate, compliant, completed and reviewed as per sit quality procedures • Compliance to all completion timelines such as and not limited to, change requests, actions, documentation updates and training • Provide technical support to… Show more • Effectively prioritizing to ensure that time and resources are optimized to support production • Prepare and report on key performance indicators and departmental activities • Ensuring batch documentation i.e. shop orders, forms, logbooks, is accurate, compliant, completed and reviewed as per sit quality procedures • Compliance to all completion timelines such as and not limited to, change requests, actions, documentation updates and training • Provide technical support to packaging lines • Delegated authority for the packaging manager • Ensuring all work is performed in a safe and compliant manner • Perform technical training Show less



IDT Australia Limited

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Manager

  • Jun 2016 - Apr 2017

  Melbourne, Australia • Operation and troubleshooting of packaging lines consisting of tablet counter, capper, bottle labeler, cartoner and labeler • Supervising the operators in packing line • Completion of documentation consist of batch record, weighting and dispensing, in process check and reconciliation • Maintain raw material and packaging inventories and ordering as per required • FDA and TGA rules and regulation knowledge in this department is necessary • Formulation and Manufacturing of… Show more • Operation and troubleshooting of packaging lines consisting of tablet counter, capper, bottle labeler, cartoner and labeler • Supervising the operators in packing line • Completion of documentation consist of batch record, weighting and dispensing, in process check and reconciliation • Maintain raw material and packaging inventories and ordering as per required • FDA and TGA rules and regulation knowledge in this department is necessary • Formulation and Manufacturing of IV clinical trial products • Dispensing and measuring the raw materials using balances, volume meters and load cells • Monitoring all tanks, vessels and containers and label status and set up the equipment’s based on the batch record • Conducting room clearance before and after the formulation/compounding • Collecting samples for QC as per request • Manufacturing and filling of powder finished products Show less



PCI Pharma Services

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Production Manager

  • Jan 2013 - Mar 2016

  3/31 Sabre Dr, Port Melbourne VIC 3207 Responsibility: • Manufacturing department responsible(manufacturing and packaging) • Designing and mobilizing solids manufacturing department • Installing, running and operating tablet press machine in the manufacturing department • Installing, running and operating tablet blister machine in the manufacturing department • Installing, running and operating tablet coating machine in the manufacturing department • Technical cooperation with tool making companies in order to… Show more Responsibility: • Manufacturing department responsible(manufacturing and packaging) • Designing and mobilizing solids manufacturing department • Installing, running and operating tablet press machine in the manufacturing department • Installing, running and operating tablet blister machine in the manufacturing department • Installing, running and operating tablet coating machine in the manufacturing department • Technical cooperation with tool making companies in order to make size parts for manufacturing machines • Responsible for new pharmaceutical formulation development(Active and placebo) • Manufacturing new projects responsible • Documentation, production, labeling, packaging and finalizing finish products based on the clinical trial process • Providing, updating and control documentation for clinical trial products • Scheduling employee tasks • Main responsible for implementing GMP rules into clean rooms • Manufacturing responsible in TGA audits Show less



Tehran Chemie Pharmaceutical CO

• Iran
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• QA manager

  • Dec 2011 - Oct 2012

  Tehran, IRAN Responsibility: • Internal and external audits according to the GMP principles • Quality risk management • Planning of training department • Providing, updating and control documentation



Darou Pakhsh (شرکت کارخانجات داروپخش)

• Iran
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Production Manager (Manufacturing)

  • Feb 2003 - Dec 2011

  Tehran, IRAN Achievement: • Developed manufacturing process skill • Remarkable waste reduction in solids department (2011) • Established documentation in solids department and got GMP approval from health ministry.(2011) • Developed high level of project skills(solids department project 2010) • High pharmaceutical machinery knowledge skill • Effective team work skill • Manufacturing program planning skill • High developed clean room skill • Time managing and outcome orienting… Show more Achievement: • Developed manufacturing process skill • Remarkable waste reduction in solids department (2011) • Established documentation in solids department and got GMP approval from health ministry.(2011) • Developed high level of project skills(solids department project 2010) • High pharmaceutical machinery knowledge skill • Effective team work skill • Manufacturing program planning skill • High developed clean room skill • Time managing and outcome orienting skill • Expert pharmaceutical documentation skill Show less