Expert Gmp Auditor

Summary Lead support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations standards and guidance documents Review and approve corrective action plans in support of the audit observations The audits performed include internal and external targets of manufacturing sites development centers quality systems contract manufacturers laboratories warehouses country organizations and suppliers Align strategic direction with senior leaders of Novartis and help establish programs to implement Provide expert consultation to Novartis business units through risk based assessments Act as SME for assigned areas of responsibility Represent the company in external interactions with Health Authorities and industry groups Expert GMP AuditorLocation - MumbaiAbout the Role Lead support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations standards and guidance documents Review and approve corrective action plans in support of the audit observations The audits performed include internal and external targets of manufacturing sites development centers quality systems contract manufacturers laboratories warehouses country organizations and suppliers Align strategic direction with senior leaders of Novartis and help establish programs to implement Provide expert consultation to Novartis business units through risk based assessments Act as SME for assigned areas of responsibility Represent the company in external interactions with Health Authorities and industry groups Key Responsibilities Contribute to establishing the strategic direction of an effective global risk-based audit strategy and program Collect collate and incorporate input into the audit strategy and plan Plan lead conduct document and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations standards quality agreements and guidance documents For this expert role the leader in this position is able to audit complex and high-risk sites and activities The leader in this position is considered an expert and SME in one or more manufacturing areas such as sterile manufacturing combination products biologics etc Provide technical guidance mentoring and training on audit activities Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing Prepare audit reports according to NVS requirements and timelines Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures Ensure adequate definition and recording of mitigation plans when applicable Assess the adequacy of responses CAPA plans to audit findings in cooperation with the stakeholder QA representative and Auditee Act as GMP compliance consultant for GMP trainings task forces continuous improvement projects as needed Review and advise on relevant policies and procedures Mentor junior GMP staff as required Ability to perform training for non-certified and junior GMP staff Maintain current expert knowledge of regulations and elaborate best practices auditing guideline when applicable Support development training of GMP auditors Support HA commitments and global commitments initiatives as an outcome of inspection findings Essential Requirements At least 15 years broad experience in Pharmaceutical or Medical Device Industry The operational experience should include QA QC management and manufacturing or development or other relevant experience e g working at a regulatory health authority At least 3 years auditing experience and excellent knowledge of regulatory requirements xc2xb7 Willingness to travel approximately 60 of the time Expertise in at least one of the following areas DP Manufacturing Laboratories activities Medical Devices API Excipients Sterile Biologics Microbiology Computer System Validation Packaging activities Quality Systems Experience and or interaction with local Health Authority and sporadically with other Health Authorities Excellent interpersonal skills including diplomacy and persuasion used in obtaining cooperation and consensus with Novartis colleagues vendors and customers The Associate must be able to effectively represent the department both internally and externally Sound and practical judgement in the interpretation and application of regulations and standards Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision Excellent leadership and facilitation skills Desirable Requirements Degree in Chemistry Pharmacy Biology Engineering or another related science Excellent oral and written English communication skills Preferable Good knowledge mother tongue of an additional language e g German French Italian Chinese or Spanish is preferred Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world How can we achieve this With our people It is our associates that drive us each day to reach our ambitions Be a part of this mission and join us Learn more here https www novartis com about strategy people-and-cultureYoull receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewardsJoin our Novartis Network If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here https talentnetwork novartis com network Skills Desired Agility Agility Auditing Business Acumen Business Partnering Business Strategy Collaboration Teamwork Communication Skills Compliance Audits Continuous Learning Dealing With Ambiguity Decision Making Skills Employee Performance Evaluations Finance Acumen Gmp Procedures Goal-Oriented Health Authorities Leadership Logical Thinking Major Incident Management People Management Problem Solving Skill Problem Solving Skills Qa Quality Assurance Self-Awareness 6 more