Job
Description
Role & responsibilities Quality Standards Leadership : Lead the development and execution of robust quality standards across operations, ensuring 100% compliance with regulatory requirements and industry best practices. Alignment of Quality Functions : Harmonize efforts across In-process Quality Assurance, Quality Management Systems, Quality Control, and Quality Engineering to ensure seamless execution of departmental objectives aligned with business goals. Quality System Management : Oversee critical quality processes, including product complaints, CAPA, supplier quality, and internal audits, to ensure sustainable compliance with high-quality standards. Investigation Management: Conduct in-depth investigations into Out of specification Results, deviations, complaints, recalls, and stability failures, focusing on effective CAPA planning and implementation to mitigate risks. Responsible for review and approval of quality system documents such as; SOPs, specifications, Annual product quality review, Master batch manufacturing records, Master packing record and dispatch record, validation master plan, process validation documents, hold time study documents, cleaned and dirty equipment hold time study documents. Responsible for approval of changes to the existing systems, documents, processes, specifications, test procedures and ensuring change implementation. Responsible to monitor the compliance of standard operating procedure. Responsible for CAPA documents Review and Close out along with respective departments. Responsible to play a major role Implementation of cGMP practices in the facility. Responsible to regulatory audits / Inspections, customer audits and audit compliance. Responsible for Gap Assessment, impact assessment, development, and implementation of harmonized policies and procedures Responsible for Reviewing documents, Protocols, SOPs and Perform Gap assessment and harmonization of Procedures and Practices Responsible for review and integration of Quality Risk Assessment into Design and Qualification of Area, Equipment, Manufacturing Process, and Contamination control strategy Responsible for the preparation and training of quality policies & procedures Responsible for carrying out Audits and ensuring compliance. Also to work on the compilation of Quality Metrics, harmonization of the regulatory observations and follow up on compliance. Provide subject matter expertise to personnel on aspects of QMS systems and Compliance. Conduct internal and external audits as part of the Quality systems improvement program. Set, Maintain, and trend progresses related to Quality across site and provide performance indicators for senior management. All time readiness at the site for regulatory inspections in collaboration with Site management in the area of operation & quality area. Provide technical support during technical investigations, risk management exercises. Identify gaps/improvement areas in its solutions and implement at site. Design & execute continuous improvement initiatives within the region to enhance compliance, drive efficiencies & cost-effectiveness. Maintain a network of subject matter experts in facilities/utilities/process validation and provide support to site in the resolution of non-routine issues. Identifying the training needs of the teams and Conducting need base training programs. The interface between various customers and internal teams during technical presentations /technical gatherings. Preferred candidate profile
