QMS Manager will be responsible for managing certification and Quality Process Compliance and implementation of effective quality management system on each project, batch release of intermediates and APIs(Application Programming Interface). Accountable for investigations against deviations, out of specifications, Client complaint, and its Corrective and Prevention Methods (CAPM) effectiveness verifications as per the identified root cause.
The manager also ensures that all necessary resources are available to support the QMS.
- Develop the Quality Management System in line with the required industry standards (including ISO14001 / ISO 9001), accreditation requirements and business requirements across the organization through existing and new procedures.
- Drive the quality improvement initiatives on Each IT Project and coordinate with all cross functional teams to avoid the data/Process integrity breaches.
- Responsible for Audit readiness and handling of various audits, response & closure.
- Support all the QMS elements for timely review, approvals, implementation, closure & tracking of the same for the quality metrics and take the appropriate actions to improve the effectiveness.
- Review and approval of Standard Operating Procedures, Specifications and Test procedures through system.
- Ensure the quality assurance programmes and policies are maintained and updated regularly according to the requirements.
- Contribute to the creation and implementation of best practice Quality strategy, policies, processes, and procedures to aid and improve operational performance.
- Maintain Document Repositories related to QMS and ISMS
- Be a part of the Internal Quality Audit Team. Plan, schedule, execute, report, monitor and track the findings to closure.
- Contribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems (QMS).
- Develop the Quality Management Systems strategy and the management arrangements for key milestones, demonstrating solid progress against plans and objectives.
- Manage all external registration requirements to ensure they are met. Liaise with external bodies on all matters relating to registration. Maintain and improve, in line with business needs.
- Implement all relevant procedures described in the Quality Management System (QMS).
- Ensure that all in-house systems and procedures are updated, revised, and modified to meet the needs of external certification bodies whilst ensuring simplicity and understanding for their use.
- Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits.
- Train others in all aspects of the quality system and application of procedures.
- Undertake regular internal/external process audits of the QMS.
- Ensure corrective actions are undertaken to address nonconformities found.
- Verify and ensure timely closure of non-conformities.
- Provide detailed analysis of the QMS KPIs to senior management.
- Ensure ongoing compliance with the Quality Management System (ISO9001).
- Lead Quality Committee meetings ensuring all aspects of the QMS are discussed and any actions are driven to satisfactory completion.
- Ensure KPIs are met by working to the plan, including management of, and reporting.
- Ensure that the function operates in accordance with any health, safety and environmental policies and procedures to ensure the safety and wellbeing of staff and visitors.
Required Skill Set:
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