דרושים Gbs Continuous Improvement Specialist ב-טבע ב-India, Bengaluru

• Perform initial problem determination (level 1) in support of scope of services with related hardware, software and services support.
• Provide in-scope technical advice and guidance, trouble shoot end users queries / issues and advise potential resolutions within specified KPIs and metrics.
• Handle service entitlement failures associated with requests for in-scope services.
• Assign records to other support groups, as and when required.
• Act as service desk's advocate when dealing with other support / resolver groups.
• Initiate the service outage procedure, update VRU status messages with outage information, as required.
• Process requests for password resets and manage the requests to satisfactory completion.
• Accurately log all interactions via established business processes and tools.
• Understand and contribute to the improvement of various performance metrics.
• Update inventory for software licenses, hardware and reporting.

• 1 -2 years' experience as a technical service desk agent
• Excellent logical reasoning, troubleshooting and problem determination skills
• Strong communication (verbal and written) skills
• Knowledge and experience with Remote takeover tools.
• Work in office is required (No work from home option)

First Line Manager

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

This incumbent

• Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
• Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
• Review of Instrument/Equipment Qualification records.
• Review of BMR.
• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system
• Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
• Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
  Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites

1. Review of CMC Documentation

• Review of Method Development / Validation protocols & reports.
• Review of Stability Study protocol, reports & grids.
• Review of Instrument / Equipment Qualification records.
• Review of Batch Manufacturing Records.
• Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.
• Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
• Contemporaneous updation of SharePoint data base

1. Data requesting and Compilation of PQR’s

• Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems
• Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.
• Follow up with the CMO‘s for the receipt of data within time.
• Check quotation received from CMO and initiate PR/PO for QP’s approval.
• Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.
• Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.
• Contemporaneous updation of SharePoint data base

1. Quality Management Systems

• Initiate the process of change controls and deviations
• Preparation of local SOP’s and its related documents.
• Participate in self-inspection process

1. Performance Management

• Participate in continuous process improvement projects to improve efficiency of the unit

1. Training

• Prepare the Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.

1. Miscellaneous Support

• Any other tasks assigned by the management for smooth functioning of the team

• 2 to 8 years of experience in QA / QC function in the pharmaceutical industry
• Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences
• Basic knowledge on worldwide cGxP regulations
• Good English language skills, other language skills could be helpful
• Good communication skills
• Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage
• Basic understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) & Stability Studies.
• Hands-on experience on Review of Instrument/Equipment qualification records.
• Basic knowledge / hands on experience of review of BMR.
• Basic knowledge / hands on experience on Product Quality Reviews.

• Is responsible receiving, categorizing, trending, logging complaints for US market and coordinating the return of the complaint Samples for product quality related complaints from customers.
• This includes handling of complaints reported by US customers (patient, doctors, pharmacist, HCP or any other customers who use or handle Teva products) via live phone call (90%), email and voicemail etc.
• QAS team member need to be logged in Avaya Phone application between 6:30 PM IST (9:00 AM EST) to 2:30 AM IST (5:00 PM EST) to receive live phone calls related to complaints handling from US customers.
• The received complaints are processed in TrackWise application including classification into multiple categories (critical/non-critical) and also sending notifications to respective manufacturing /packaging sites located globally requesting investigation.
• Additional responsibilities include completion training in LMS (QAS process related) and STUDIUM tasks, handling reconciliation activities related to PV, complaint samples returned and participate in team meetings.
• Phone Etiquettes and Customer Service Skills:
  1. Positive Customer relationships with productive interactions related to Complaint issue, Gain better understanding of the issue, obtaining more information. Provide update on investigation status. Coordinating and checking the availability of Complainant Sample for return to investigating sites3. Strong communication skill in English language
  4. Patience and Empathy towards customers
  5. Attention to detail and problem-solving skills
  6. Multitasking ability

• Complaint Processing:
  Performs the functions associated with receiving, trending, logging, and coordinating the return of the complaint samples for product quality related Complaints. This includes complaints received via live phone call, email, and internet.
  Utilize knowledge and experience from processing of live complaint calls to lead by example.
• Assists QAS Intake team management in handling of QAS Intake team activities:
  Serves as a Subject Matter Expert on all In-Take Team complaint processes and scenarios and assists QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions.
  Collaborate with QAS team to discuss and calibrate on different complaint scenarios on how records should be handled during weekly team meeting.
• Participate and contribute to the continuous improvement activities of the QAS group:
  Participate in the continuous improvement of the QAS Group to drive operational excellence by performing a variety of tasks and projects to increase compliance, efficiencies and effectiveness of actions within the Group.

• Bachelor of Science Degree in a scientific field preferably, Pharmacy, Chemistry, Micro-Biology, Life sciences, etc.
• Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP) but not mandate
• Understanding of Product Quality related Complaints and Adverse Events; Deviations/Investigations/Root Cause Analysis, CAPA;
• Data Integrity and TrackWise but not mandate.
• Excellent written and verbal communication skills in English Language
• Flexibility to work in continuous permanent night (6:30 PM to 2:30 AM IST)Availability to take phone calls with external customers continuously during the US business hours.

• Perform initial problem determination (level 1) in support of scope of services with related hardware, software and services support.
• Provide in-scope technical advice and guidance, trouble shoot end users queries / issues and advise potential resolutions within specified KPIs and metrics.
• Handle service entitlement failures associated with requests for in-scope services.
• Assign records to other support groups, as and when required.
• Act as service desk's advocate when dealing with other support / resolver groups.
• Initiate the service outage procedure, update VRU status messages with outage information, as required.
• Process requests for password resets and manage the requests to satisfactory completion.
• Accurately log all interactions via established business processes and tools.
• Understand and contribute to the improvement of various performance metrics.
• Update inventory for software licenses, hardware and reporting.

• 0 - 1 years' experience as a technical service desk agent
• Excellent logical reasoning, troubleshooting and problem determination skills
• Strong communication (verbal and written) skills
• Knowledge and experience with Remote takeover tools.
• Work in office is required (No work from home option)

First Line Manager

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Minimum 1-4years of overall experience in Complaints handling,
• Bachelor’s degree of Pharmacy (B. Pharm) or Master’s Degree in Pharmacy (M. Pharm) and also MSC if candidate is fitting in criteria required
• Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP) but not mandate
• Understanding of Product Quality related Complaints and Adverse Events; Deviations/Investigations/Root Cause Analysis, CAPA; Data Integrity and TrackWise but not mandate.
• Excellent written and verbal communication skills in English Language
• Flexibility to work in continuous permanent night (6:30 PM to 2:30 AM IST)
• Availability to take phone calls with external customers continuously during the US business hours
• Experience from regulated market preferred
• Shift: Night Shift (6 PM to 3 AM)
• Hybrid Working (3 Days working from office and 2 days working from home)

Sr Mgr Commercial Quality

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Serve as an initial point of contact for Veeva Global GxP business questions related to QMS and EDMS processes.
• Act as a primary business liaison with the IT support (FAS) team for operational support activities.
• Lead updates to system-specific SOPs, WIs, CBTs as driven by business needs.
• Review and approve master data requests.
• Enhancement/change reviews:
• Triage and initial review of system standard releases and new feature requests and business enhancement requests for feasibility with IT.
• Participate in system change request/release review and prioritization meetings (Change Advisory Boards) with counterparts in Information Technology (IT), Compliance, sites, and other internal Teva functions, and work with global teams to manage these requests towards features or usable workarounds.
• Support Global Business Owners during enhancement and change request reviews with the Business globally, including managing global business reviews of enhancement requests and compiling business feedback as part of enhancement planning.
• Ensure ongoing operational activities for the Veeva Global GxP system are aligned with global processes and standards.
• Conduct additional business training as needed post go-live to help adoption at sites.
• Partner with the appropriate functions (Business, IT) to provide issue resolution.
• Escalate issues to management as needed.
• Participate in system periodic and user access reviews.
• As needed, act as a Global Business Owner for system validation activities for operational changes (review/approval of system requirements and other validation documentation, approval/execution of system testing, etc.).
• Provide updates in Quality Global/regional/leadership meetings as needed.

• Bachelors in Science is required and advanced degree preferred in science/regulatory/computer science/management field
• Minimum of 5-7 years in pharmaceutical or related industry is required
• In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices
• Knowledge of cGxP requirements, Quality related IT applications, and computer system validation and deployment
• Demonstrated experience with managing complex activities
• Must have international experience and experience working with large cross-functional teams
• Technical knowledge and expertise with Quality Management computer systems including Electronic Document Management Systems (EDMS)and Quality Management Systems (QMS) and processes (such as deviations, CAPA, laboratory investigations, complaints, trends, change control, document management, notification to health authorities, notification to Management, etc.).
• Skilled with Excel, Word, PowerPoint, MS Project and SharePoint
• Demonstrates resourcefulness and initiative and creates an appropriate level of urgency to meet objectives and deadlines
• Fluent in English
• Verbal and written communication excellence required
• Veeva Quality system knowledge a plus
  

Group Leader, Quality assurance

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To drive the continuous improvement culture in GBS, by training & mentoring lean Six sigma methodologies across GBS, drive & mentor continuous improvement projects to improve operational efficiency, service quality, Optimize and Standardize processes across various functional areas.

• Lead the deployment of Lean Six Sigma methodologies across various GBS teams & processes.
• Process Optimization: Facilitate VSM/Kaizen events, streamline processes to eliminate waste, improve efficiency, and enhance overall performance. Drive Continuous Improvement projects at org level.
• Collaborate with Functional teams to drive process automations/BOTs.
• Training and Mentoring: Develop and implement standardized global lean six sigma training programs for various level. Conduct training sessions across different time zones and ensure consistent understanding of Lean concepts. Mentor Lean Six sigma trainees & projects and guide them to achieve various certification levels.
• Initiate, Drive NPS/PSQI Surveys and actions to improve the engagement scores/Customer experience.
• Facilitate collaboration across global teams and locations. Bridge communication gaps, leverage technology for virtual collaboration, and ensure that Lean principles are applicable and relevant in different regions.
• Problem-Solving: Adapt problem-solving approaches to diverse situations. Utilize flexible problem-solving methodologies that can be applied across different organizational contexts.
• Performance Metrics: Define and monitor performance metrics. Develop metrics that are relevant and measurable on a global scale, considering variations in business needs, customer expectations, and regional priorities.
• Best Practices Sharing: Facilitate the sharing of best practices. Establish mechanisms for sharing successful Lean practices and lessons learned across diverse regions within the organization.
• Initiate & drive several Lean Six Sigma practices to encourage people participation in continuous improvement, build OpEx mindset in GBS, thus improve the lean maturity of the GBS Sites.
  

• University education in Finance/Science/Engineering is required.
• Minimum experience of 10+ years in Operational Excellence role – preferred in Finance operations / FP&A.
• Certified Lean Six Sigma Black Belt /Lean Expert and practical application knowledge.
• Ability to train and mentor Lean Six Sigma topics to various level of stake holders.
• Ability to drive Change management initiatives at Org level.
• Preferred Project Management Professional (PMP) certification.
• Preferred good working knowledge of FP&A/Finance operations processes and associated SAP modules.
• Influencing and negotiation skills - Ability to get the work done with different level of stake holders.
• Fluent verbal and written communication in English.
  

Director – Transformation and PMO

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