Operational Quality Lead (Jamshoro) JobsPrivate Job GSK
Site Name: Pakistan – Sindh – Jamshoro Posted Date: Jan 12 2021 This Role Will Be Based In GSK’s Jamshoro Plant Job Purpose Manage Quality Assurance (QA) activities within the Operating Unit (OU) to ensure compliance CH products throughout their Product Lifecycle with GSK Quality Manual and all relevant regulatory and legislative requirements Lead the development maintenance and rolling review of quality systems within the OU to support the business continuity, Implement quality action plans at OU to minimize business risks. Establish and maintain Quality Systems for the OU; ensure that Standard Operating Procedures (SOPs) are in place and that compliance with cGMP is maintained through ongoing training and internal audits. Ensure and oversight proper Monitor activity and evaluate the level of cGMP compliance for products manufactured, packaged, tested and released at site through key performance indicators (KPIs) and Key Quality Indicators (KQIs). Education & Experience Masters/Doctorate or equivalent B. Pharm, Pharm D. or MSc (Chemistry or Microbiology) 10 15 Years experience in Pharmaceutical Industry with at least 5 years in managerial role Related Skills Able to collaborate with cross functional teams and address issues related to daily operations. Excellent Presentation Skills Well conversant with DRAP guidelines Hands on experience on different systems such as dMERP (SAP, Quality Work Flow etc) Achievement focused and able to work in a direct and often pressurized environment. Able to work with people at all levels of the organization, and external parties Ability to work in an environment characterized by constant change Knowledge of local / international legislation to ensure that the company meets its legal obligations. Knowledge and understanding of quality responsibilities, systems and standards Key Responsibilities Actively manage the local QA Operations team and set up their development and business objective targets. Implement GSK Quality Management system and GMP requirements within the OU and provide Quality direction and support for all quality/GMP matters. Support in initial investigate, manage and actively resole quality investigations as needed e.g. deviations, complaints, and involve GSK functions to minimize impact on product availability and sales. Use appropriate QA management tools to monitor and ensure compliance on an ongoing basis e.g. audits with appropriate follow up, risk assessments, Product Optimization action plans, and performance indicators, follow up stability and product quality review. Monitor ongoing compliance and assist with preparation, management and follow up of Health Authority inspections, as needed. Support Technical team for process and cleaning validation activities and production site tech transfers. Ensure and oversight proper line clearance/start control operation, in process checks of various production areas at defined intervals are performed and arrange samples for physical and chemical testing as well as samples for stability studies from different stages of manufacturing and packing. Ensure and oversight that analytical equipment is qualified, calibrated and maintained. Ensure timely preparation of weekly and monthly reports as well as timely submission of monthly KPIs. Direct oversight of the batch review and release function to ensure compliance to regulatory filing requirements and CGMPs, as well as GSK policies and procedures. Review any changes to batch documents (Manufacturing and Packing Instructions). Main liaison between production operations and QA batch release for process and system related issues. Ensure all GMP documents / batch history files are archived and reference samples are kept in archive / reference room respectively. Positively interacts with internal and external associates to quickly and effectively resolve operational related issues and implements means to prevent recurrence. Assists in inspections and internal audits by involving in inspection / audit discussion and by coordinating and ensuring supply of required information and documentation in a timely manner. Ensures timely review of batch documentation files and product release as per agreed timelines with supply chain to fulfil market needs and to meet sales target. Timely escalations of any issues that may prevent to release the product in time and with the necessary quality to meet regulatory expectations and GSK internal requirements. Attend the site change control meetings as a panel member at defined frequency to review the status of all change control related the area. Organize and mange comprehensive trainings on GLP, QMS (LSOPs & CHQS SOPs), instruments, etc for all QA Operations personnel Develop core competencies by managing development program for management staff. Ensure that all QA Operation personnel are trained and qualified to execute their duties. Provide leadership directives and support on quality issues. Utilize active thinking to generate creative solutions to complex technical problems. Proactively manage interactions and commitments to HA and GMP inspection findings and site Inspection readiness. Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines. Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines. Any other responsibility assigned from time to time as per business requirements. 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