Product Quality Complaints Management:Record product quality complaints into the complaint tracking system, notify the supplier, review the completed investigation, close complaints within the required timeframes, and respond to the customer, reconciliation with internal and external Pharmacovigilance teams and sponsors for AE/ complaints. For critical complaints, escalation to senior management for potential product quarantine, report to TGA or recall. Release for… Show more Product Quality Complaints Management:Record product quality complaints into the complaint tracking system, notify the supplier, review the completed investigation, close complaints within the required timeframes, and respond to the customer, reconciliation with internal and external Pharmacovigilance teams and sponsors for AE/ complaints. For critical complaints, escalation to senior management for potential product quarantine, report to TGA or recall. Release for distribution:Receive and review supporting documentation to confirm the compliance of each batch of finished product against the internal and external requirements before authorising release for distribution.Notify the supplier within contractual timelines of any identified defect.Support in:Supplier QualityChange ManagementQuality Management SystemRecall processNew Product Introduction Show less

Key Responsibilities• SMEs for deviation and batch release processes• Final product release to meet shipment plan and release cycle times• Deviation review and approval• Customer complaint investigations• Generation of site data/comms• Maintain documentation and retention samples• Review and approve the following documents on an as needs basis:• Artwork• Batch directions and protocols• Product guides• BOMS’• CAPA… Show more Key Responsibilities• SMEs for deviation and batch release processes• Final product release to meet shipment plan and release cycle times• Deviation review and approval• Customer complaint investigations• Generation of site data/comms• Maintain documentation and retention samples• Review and approve the following documents on an as needs basis:• Artwork• Batch directions and protocols• Product guides• BOMS’• CAPA closure Show less

ABS Pharmapak is a secondary packaging partner for major pharmaceutical companies.My duties are:• Review and Release for Supply or Release for Further Processing of finished product• CAPA management and review• Investigate customer complaints• Raise deviation and reports• Raise non-conformance reports to suppliers• Review and approve Finished Product Packing Specification• Risk Assessment• Review CoA & CoM against product specification• Document… Show more ABS Pharmapak is a secondary packaging partner for major pharmaceutical companies.My duties are:• Review and Release for Supply or Release for Further Processing of finished product• CAPA management and review• Investigate customer complaints• Raise deviation and reports• Raise non-conformance reports to suppliers• Review and approve Finished Product Packing Specification• Risk Assessment• Review CoA & CoM against product specification• Document control• Assist NPI to review all packaging material specifications and regulatory requirement• Liaise with customer to implement new or updated packaging material under change control process• To perform validation and qualification for all in house equipment and process• To manage the Environmental monitoring (particles and microbiological)• Assist internal and external audits• GMP practice monitoring throughout the premises and production Show less

Formrite is a plastic packaging and point of sales displays manufacturer. My role is to manage all QA aspects and to maintain QSM in accordance to ISO9001. I am responsible for the day to day quality issues arising from internal and customers, continuous improvement through quality program. During my service in Formrite I have developed HACCP Program, GMP procedures and obtained HACCP Australia accreditation for the company. I also managed the display and packaging projects. I have started… Show more Formrite is a plastic packaging and point of sales displays manufacturer. My role is to manage all QA aspects and to maintain QSM in accordance to ISO9001. I am responsible for the day to day quality issues arising from internal and customers, continuous improvement through quality program. During my service in Formrite I have developed HACCP Program, GMP procedures and obtained HACCP Australia accreditation for the company. I also managed the display and packaging projects. I have started a feasibility study on out-sourcing high volume products for meat processing company.Achievements:• HACCP Australia accreditation in 6 months• ISO9001 accreditation audit • Internal auditor—complete a training program with SAI Global• Set up VMI supply to a customer• Use Axapta MRP system Show less

Being responsible for technical aspect of GSC outsourcing, this role required the highest level of technical knowledge, quality sense, accuracy, communication skill and efficiency. Quality & technical advice was offering to supplier to improve their process, cost, efficiency and quality. Project management in the like of process design and product quality specification was my duty to ensure new products were implemented and delivered on time and within budget. I was also actively involved in… Show more Being responsible for technical aspect of GSC outsourcing, this role required the highest level of technical knowledge, quality sense, accuracy, communication skill and efficiency. Quality & technical advice was offering to supplier to improve their process, cost, efficiency and quality. Project management in the like of process design and product quality specification was my duty to ensure new products were implemented and delivered on time and within budget. I was also actively involved in new supplier evaluation & RFP review. Not forgetting to mention, preparation of BOM, drafting & reviewing quality procedure/ guidelines / standards and processing ECR/ECO were my duties.Responsibility:• Project management of new products introduction towards mass production• Transfer of in-house product by modules to be produced in Asia• Develop & maintain technical & quality guidelines for Products• Process and first article approval• Set up supplier audit procedure and reporting• Supplier audits• Monitor & improve supplier quality performance• Processing & monitor ECR, ECO, CAAP(Corrective Action Advise Process)• UL split inspection coordinator• Assist and guide suppliers to establish UL split inspection requirement• RFP review & new supplier capability evaluationAchievements:• Pioneer and explorer of first outsourced Aristocrat module from China in 2003• Managed and completed project Level 4 cabinet medium/ high complex assembly VMI outsource from China in 2005• Successfully developed Barcoo level 4 cabinet manufacturing and mass production from China in 2006• Commissioning 175 of Barcoo machines in South Africa (first pilot production)• Develop and complete new level 4 Viridian cabinet first article and started VMI production between 2007 to 2008• Supply & install 1200 poker machines for Venetian Casino Macau Show less