Valina is a validation and qualification services provider for IT GxP systems used in regulated environments in Drug Safety, Manufacturing, Clinical Development & Management.Headquartered in Singapore and serving clients globally, Valina responds to the needs of the Pharmaceutical, Biotech, Medical Devices, Cosmetics, Food, and the additives sector to meet their regulatory challenges in managing the qualification of their IT systems, equipment, and instruments used for manufacturing their products, medicines, drugs, food, and cosmetics.I am working at Valina, for quality and validation activities of the Safety Easy application (SaaS) for the client AB Cube, France.-Creating and reviewing of Procedures, SOP.-Manage Records and templates for tracking the quality activities carrying out in the organization.-Audit follow up and CAPA monitoring.-Address customer questionnaire and handling support through Fresh Desk on quality matters.-Track of incidents and Deviations to close before deadline. -Implement quality management systems for continuous improvement of the quality of the product and services provided.Skills: ISO 9001 · GxP · Standard Operating Procedure (SOP) · Complaint Management · Good Manufacturing Practice (GMP) · Corrective and Preventive Action (CAPA) · Quality Control · Change Control · Continuous Improvement · Risk Management · U.S. Title 21 CFR Part 11 Regulation · GAMP · Computerized System Validation (CSV)

- Leads complaint investigations, failure analysis- Resolves quality issues by identifying problems examining solutionoptions, implementing action plans.- Established, implemented and maintained the quality managementsystem- Documentation on the executed quality process control plan.- Keep track of his team's analytical repeatability and reproducibility.The outcome must be effectively conveyed and presented.- All of the QC equipment in use is precise and calibrated on aregular basis.- Key personnel in Wafer Level Optic Project (Plan, conduct andmonitor testing and inspection of materials and products to ensurefinished product quality)- Proper keeping of reference samples (Physical & Documentation)for raw materials, packaging materials and finishedproduct according to the Quality Inspection Plan- Assess competency of all subordinates and ensure they aremotivated, well-trained, and capable at their jobs.

- Work closely with engineering / operation team in generating quality requirements to support on-going transfer of existingproducts into the manufacturing line including generating required quality plans/reports, associated process, equipmentand product validation and verification protocols.- Involving in investigation related to quality assurance and operation activities and implementation of CAPA as per investigation outcomes.- Initiation of change management,deviations and CAPApertaining to quality assurance.- Lead/ support meetings to discuss issues and address formal non- conformance within the CAPA systems and also supportthe day-to- day activities required to address manufacturing nonconformances.- Qualified reviewer of production batch manufacturing records, batch packing records, validation reports and also responsible for batch release.- Working and supporting the team in internal and external audits (regulators/ customers/partners).- Preparation of standard operating procedure (SOP) for quality assurance department and also involve in reviewing production’s SOP prior to approval.- Represent the quality assurance department on cross functional projects teams.- Analyze and investigate market complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.

- Inspect incoming raw materials and packaging materials qualityand quantity to ensure adherence to specifications.- Maintaining HACCP and GMP documentation along withproduction process flow.- Involve in research and development of new products and alsoconduct sensory evaluation.- Perform in-process checks, line clearance and finished productsampling.- Online reviewing of batch records and monitoring ofmanufacturing activities.- Ensure adherence of compliances at quality assurance areaand to notify non-conformities.- Involve in customer complaint investigation and analyzethe frequency of the occurrence.