Senior Manager- DP Medical Device & Visual Inspection

Educational Background and Experience Required:M.S/MBA or equivalent (preferably in Mechanical, Industrial or other Engineering background in IIT, NITTE, IIM's, Tier I Institution)10-15 years of industrial experience, of which min. 5 years within multinational pharma/biopharma companiesExperience must include facing FDA, EMA, Anvisa, Health Canada, AustraliaProject management skills, lean six-sigma (any belt)Main missionalignment with BBL strategy and mission to provide affordable medicines to patients. Department lead should be able to lead and drive packing operations, ensuring best-in-class level performance, compliance and effective and standardized deployment of Lean six-sigma mindset and approach.drive Medical Device department performance, ensuring implementation and optimal use of tools and data analyticsRole/Job Descriptionpeople and up keeping of facility in anticipation and preparedness to face audit at any given point of time.and scheduling of production activities for optimum utilization of resources in the production department.quality of product is always met, by providing training and mentorship to team in following SOP's and other relevant documentsof manufacturing processes(s), and develop KPI for packing department.and root cause analysis on shopfloor and providing practical solution.carry out all the activities in compliance and the cGMP requirements and as per GDP.Candidate must be able to trouble shoot issues by working with CFT's and closely work with Engineering maintenance teamShould be able to articulate well with CFT's and ensure tasks are completed on time.Should be able to handle a team of 30-40 members and manage multiple shiftsCandidate establish metrics for on-time delivery, compliance and trainingto safety, health and environment measures.Technical / Functional Skillsunderstanding of Visual Inspection (Manual & Automatic) and experience of cGMP, Qualification, Validation, 21 CFRunderstanding of pharma operations in an international and FDA-EMA regulated environmentexperience in medical device and having injectables experience is a plus.Any certifications such as ASQ is a plusBehavioral / Management / Others killsleadership, ability to foster mindset change, overcoming resistance and barriersrecord of successful cross-functional leadershipPersuasive and determined, able to convince multiple stakeholders and to handle complex situationsAbility to work under pressure and cope with multiple prioritiesExcellent communication skills, up to ELT level and key external stakeholdersStrong analytical and problem-solving skills PRB