Responsible for establishing a corporate Quality Operations based on culture of "Compliance and Quality everyone's responsibility " in the Organisation.
Client Details
A leading pharmaceutical company.
Description
Develop, implement, manage and integrate an effective QMS (Quality Management System ) meeting all requirements of cGMP and drug laws where applicableEstablish and implement Quality metrics (process capability, change control, Non conformances / deviation etc ) monitoring and reporting system and to ensure its effectiveness in order to take sound and appropriate Quality decisionsEstablish effective strategies, quality systems and procedures to assure appropriate compliance with all GMP /GLP directivesEstablish a comprehensive Quality review process (PQR) as per latest pharmacopoeia / regulatory requirements considering all aspects including pre/post analysis data of commercially marketed products. Identify the gaps and improvements in each PQR of productDevelop and implement management Review process based on participation of top management to review the Quality management system, at planned intervals to ensure its suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes including the Quality objectives. At least 2 Management review meeting shall be done in a calendar year.Ensure all products related Markets complaints are addressed with appropriate investigation and CAPA (Corrective and Preventive action) within the specified time frame. Acknowledgement and reply about investigation / action taken must also be sent to all complainant including hospital / institution , doctors, distributors etc.Design, implement and document procedures for process control, process improvement, testing and inspection for material receiving to final release of productsHelp to manage Quality control procedure on a day-to-day basis and serve as the primary quality control resource for problem identification, resolution and continuous improvementMonitor vendor performance and establish system for vendor Qualification and approval based on vendor facility Audit considering nature of material usedReview / Report Quality issues / problem and trends about existing / potentials non conformance to Managing Director.Manages and conduct audits and inspections of internal and external including vendors, TPM / trial sites, or other facilities to ensure adherence with the quality Management system requirements.Ensure All Quality agreements are done as per basic requirements of Quality management system and cGMPDevelop and implement effective CAPA system and ensure root-cause analysis and other problem solving activities as per recommended corrective / preventive actions .Ensure the system of Internal Quality audits considering all functional areas which has impacts on product Quality based on material receiving to final release of products and also at distribution levelsReview customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in Quality management system .Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.Review / Give feedback on suppliers purchase orders and establish supplier quality requirements.Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.Support the site by participating in design development projects representing Quality assurance and the customer.Establishes and allocates Quality Assurance resources from assigned functional group to support all appropriate objectives. Provides detailed information to the Functional Planner, Project Planners and other functional groups regarding the progress of Quality Operations.Manage to achieve the Quality Opera
Skills
quality, pharma, QC, QA, QMS, manufacturing site, plant manager