R&d Quality Manager

4 days ago

Hyderabad Telangana, India Novartis Full time

Summary Independent Project work less complexity e g early phase projects Lead or support smaller and less complex projects or support more complex projects with mentoring Higher complex routine tasks e g failure investigations and deviation change controls etc Manage projects and processes to support departmental portfolio projects and objectives according to agreed timelines and standards Ensure that compliance with cGMP is maintained in TRD Key Responsibilities Support a discipline and or provide a service individually or within a team of associates May provide functional expertise to Line Unit and other QA Units in area of responsibility Write review decide on approval and or release of GMP-relevant deliverables and or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables Manage project related activities e g TRD product portfolio development of new tools processes Quality initiatives Quality Manual implementation Quality Plans Quality Risk Assessments training activities qualification and facility upgrade activities IT validation projects as per area of responsibility Support Project management functions as a project team member Provide support to TRD line functions in GMP related topics as per area of responsibility Comply with internal and external guidelines regarding quality and safety Quality Manual regulatory cGMP guidelines Health Authority guidance SOPs etc Minimum Requirements Masters Bachelor Technician 5 years pharma Fluent English required oral written Good skills in site local language desired Good knowledge of cGMP working knowledge in technical development production or QA Sound scientific technical and regulatory knowledge Good organizational and decision-making skills Good and proven ability to analyze and evaluate cGMP compliance Commitment to Diversity and Inclusion Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to diversityandincl india novartis com and let us know the nature of your request and your contact information Please include the job requisition number in your message Skills Desired Agility Analytical Development Auditing Audit Management Business Partnering Change Control Continued Learning Health Authorities Influencing Skills Knowledge Of Capa Qa Quality Assurance Quality Management Risk Management Root Cause Analysis RCA Self-Awareness Six Sigma Sop Standard Operating Procedure Technological Expertise

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