Quality Assurance Specialist (1 Year Contract) - #1090910

Job Responsibilities: 

• Ensure all repackaging activities are carried out in accordance with authorized specifications and that quality checks are performed throughout the process in a stringent and effective manner.
• Check and approve repackaging requirements of products and materials according to Client and regulatory requirement. Full review of batch records to ensure compliance per the repackaging instruction and GMP standards. 
• Verify correct execution of repackaging activity against approved / updated repackaging instructions. 
• Perform required quality checks and create quality inspection lots in SAP. 
• Record Inspection Results and perform Usage Decision and stock posting. Issue necessary documents to facilitate release. 
• Liaise with Regulatory Pharmacist to ensure timely release of goods after QA checks or perform final sign-off of repackaged goods release after all releases have taken place.
• Authorize to stop any repackaging activities, when necessary. 
• Perform other QA release (e.g. cold chain temperature release, outbound release) if required. 
• Updating of logs and trackers as required. 
• Perform back-up and other duties as assigned. 
• Ensure compliance to ISO procedures, GxP and all regulatory requirements.
• Ensure general cleanliness and hygienic conditions of each workstation. 
• Work closely with inter-departments personnel to ensure quality is maintained throughout the organization. 
• Conduct internal audits, training and general communication to achieve and sustain a high level of quality performance throughout the organization so as to properly support the business and regulatory (ISO, GMP, GSDP) requirements in the most efficient manner.
• Participate in any ad hoc projects as assigned by management from time to time. 

Job Requirements:

• Diploma in any related discipline or good knowledge in Quality / Compliance areas in manufacturing. 
• Preferably relevant experience in Quality Control / Quality Assurance works in manufacturing / production / assembly / operation environment. 
• Knowledge in ISO, GMP and GSDP preferred. 
• Quality-oriented and Customer focus.
• Meticulous with good attention to details. 
• High initiative to be able to work independently without supervision.
• Good team player with good verbal and written communication skills.
• Must be able to work in a fast-paced environment. 
• Willing to work in cold room environment to perform cold chain QA release. 
• Willing to work flexible and extended hours and depending on the exigencies of service.