Quality Engineer supporting for QMS Remediation.Fostering a good quality culture and continuous improvement within the organisation: drafting Quality documents such as SOPs, Work Instruction, Manufacturing Procedures. Conducting and supporting Quality Audits and change control implementation.

 Perform document DHF remediation activities. Working in harmonization of different sites procedures. Performing Gap assessment of site documents with the global documents and remediate the gaps. Review the Problem Description and Problem type using a defined template and identify incomplete gaps. Prepare the final harmonized documents under the different QMS elements. Performing as a Configuration controller role in the project & handling all the activities related to Configuration Control register. Participate in Internal Audits, Project compliance audits & Client mock audits. Responsible for on-time projects delivery and to ensure the Quality of deliverables.

 Monitored facility and implemented Quality systems for products in accordance to cGMP and ISO standards. Managed all engineering problems of facility. Determined validation program for process and product in compliance with required protocols. Ensured that Quality Assurance standards were maintained throughout product life cycle. Inspected design and manufacturing facility and performed root cause analysis while defects identified. Trained junior staff department in implementations of various quality tools and procedures. Documented process and prepared reports to be presented in technical presentations. Provided technical support to PMS, CAPA and resolved all quality issues. Responsible for master Document preparation, controlling of the documentation and review of documentation. Conducting Internal Audits as per ISO 13485:2016. Participated in the external audits ISO 13485:2016 Involve in various QMS related activities as per Regulations.