Seeking a challenging career with a progressive organization that provides an opportunity to capitalize my Technical skills, Experience abilities in field of ISO Management Systems such as QMS 9001, 13485, 18001, 14001 etc and training by virtue of hard work.
Delvelop and maintain ISO 13485:2016, MDR 745/2017
Head of GMP department
Conduct Internal Audit
Control drawings, master samles, dies, gauges, processes
Develop QA/QC system processwise
Conduct Processes validations such as Hardening, Ultrasonic cleaning, Electropolishing, Passivation, Boil test
â€¢ Ensure the quality system is established, implemented and maintained in compliance with all applicable FDA Quality System Regulations, ISO 9001:2015 and ISO 13485:2016
â€¢ Coordinates the external audit program with Germany & local bodies of Pakistan such as QA INTERNATIONAL and Bureau Veritas Pakistan
â€¢ Coordinate and evaluates the activities of the plant site Quality System and regulatory compliance programs.
â€¢ Continues assessment of industry and regulatory trend to assure systems meet requirements
â€¢ Oversee the internal audit program
â€¢ Response customer complains
â€¢ Oversee corrective and preventive action (CAPA) program
â€¢ Oversee engineering services function
â€¢ Leads management reviews and preparation of Quality Assurance reports.
â€¢ Identifies areas requiring quality improvement and initiatives and follows through on action plans necessary for implementation.
â€¢ Responsible for team building, identifying resources gaps and working in collaboration with personnel to create personal development plans to enhance the capabilities of the department
â€¢ Plan and delivered the ISO (9001:2015, ISO 13485:2016) trainings of Managers and other staff.
â€¢ Prepare the production procedures, Quality Manual and Job Descriptions
Drive and monitor Audits of the company according to the Audit Program
- Ensure the completion of the audit - Coordination with the auditors for the timely submission of audits reports (ISO 9001:2008, 9001:2015, 14001:2004, 18001:2007 & GMP 22716).
- Ensure that conclusions of the audit are understood by the auditees.
- Timely Initial technical Review of Audit reports include Certification, Re Certification and Surveillances audits.
- Analyzes audit reports, make recommendations that are usable and workable for auditees and the Quality Management Team. - Follow-up of audit reports.
- Maintenance and updating of Auditors log SF-27
- Issuance of Recommendation letters.
- Timely issuance of certificates to clients
Manage and monitor nonconformities with respect to the ISO Standard.
- Ensure that nonconformities are correctly entered into SF-02 form and all section are fulfilled
- Make sure relevant persons are notified on occurrence of nonconformance - Follow-up of NCRs treatment from Auditee and maintenance of NCRs log. - Issuance of NCR closure letters.
- Assist Technical Department in audits against the requirements of BMS, ISO 17021 and Accreditation Boards. - Assist Technical Department in accreditation Audits and accreditation related affairs. - Assist Technical Department in the implementation, updating and maintenance of data tools like SIEBEL.
- Assist Technical Department to complete the auditors data for codes allocation according to their education, experience, trainings etc.
- Provide assistance and support to Technical function of BV Certification Pakistan.
-Complete the records, documents and files for external audits
-Assist the Commercial Department to submit the proposal, sign contract of new clients and recert clients within time for SIEBEL.
- Maintain the training records of standards ISO 9001:2008, 9001:2015, 14001:2004, 18001: