Operational Quality Lead

Job Description

Site Name: Pakistan - Sindh - Jamshoro Posted Date: Jun 23 2022 Job Purpose Manage and lead the Operational Quality activities related to manufacturing, packaging and warehousing to ensure compliance to GSK?s Quality Management System (QMS) & local regulatory requirements through collaboration with cross functional teams. Ensure GSK Values & Expectations are upheld. Key responsibilities Inspection readiness of operations / Operational Quality oversight Shift-based oversight of facilities, equipment and personnel to ensure real-time compliance to procedures, instructions, contemporaneous data integrity and other cGMP requirements Ensure OQ team is embedded in site standard work ? gembas, performance boards, standardization of Quality Sections of GPS Visuals for Tier 1 Meetings, seating with Operations, etc.. Support investigation, RCA of complaints or deviations, support risk management, change controls management and CAPA effectiveness checks in Operations. This includes participation in Rapid Response approach to address deviations, with Operations, Engineering and Technical, assessment of deviation investigations, associated CAPA effectiveness and trending of Operations deviations Performance management of key operational Quality KPIs, including real-time KPI?s reporting and trend evaluation Identify potential GMP violations through proactive risk and incident identification, escalation and management. Support implementation of operational QMS topics on site (manufacturing, packing, warehouse, utilities, rework, trials, etc). Comply and ensure compliance to GMP, EHS, Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines. Translation of regulations into compliant effective processes Support GxP refresher training for operations (including Data Integrity) Support Operations? MMs and IBMs Oversight of Batch record review and Product release: Review of batch documentation, test results and all other documentation associated with release of Finished Product Batch release on time improvement Support batch RFT improvement Continuous improvement: Building a culture of continuous improvement to improve Quality and to sustain the results. Support or drive implementation of the appropriate solutions across site to improve right the first time, documents flow, productivity, performance, schedule adherence, and customer service while reducing cycle times. Embed Quality by design Provide key input into Quality decisions and Quality Council Ensure annual review of quality system effectiveness OQ team management, development and coaching: Develop team technical capability - On the job / on the shop floor experience to understand and learn about the manufacturing, packaging and warehousing processes. Rotate the value streams the OQ team members look after. Complement with classroom training (e.g. some QP or cauditor certification modules, product understanding, etc..) Develop team?s soft skills ? influencing, listening, etc.. Other responsibilities ? e.g.(site flexibility) Acting as QP Responsible for disposition of GSK imported products which are registered with local HA Review and approve master batch records Oversight of analytical equipment in Operational Quality Lab to ensure that they are calibrated, qualified & maintained Supervise Archiving and retention sample storage rooms and ensure that temperature requirement is being met and recorded Oversight of IPC. 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. Educational Background Preferred Level of Education: Master or Equivalent and minimum 5 years of experience in the pharmaceutical industry Area of Specialisation: Quality system experience and experience in manufacturing or market organization Job-Related Experience Minimum 5 years in the pharmaceutical or consumer industry with preferable operational and Quality experience Knowledge of Quality Assurance Systems and cGMPs Understanding of working in a highly regulated environment. Other Job-Related Skills High level of integrity Sound Technical Knowledge Balanced judgement Good decision-making skills; able to make difficult decisions; with a disposition for continuous improvement, innovation & creativity Strategic thinking Resolve and offer solutions to complex quality operational issues Attention to detail Team player Strong knowledge of regulatory and quality requirements and breadth in quality systems principles and practical applications People Management Good knowledge and application of quality and risk management principles and tools Ability to effectively prioritise work Good verbal and written communication skills Able to work effectively in English Self-starter, able to schedule and progress workload on own *This is a job description to aide in the job posting, but does not include all job evaluation details Contact information: You may apply for this position online by selecting the Apply now button. 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