דרושים Opex Lean Specialist - Tapi ב-טבע ב-הודו

• 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

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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.

• Carrying out dispensing activities as per applicable procedure.
• Carrying out process and sampling activities during the production of Intermediate /API’s according to approved batch cards.
• Responsible for recording the observations of reaction parameters on the batch card as per approved procedure.
• Filling of all the batch cards (production cleaning) as per approved instructions.
• Ensure verification of pH meters and weigh balances as per applicable procedures.
• Maintain work procedure, safety precaution and cGMP.
• Contributes to the development of new concepts, techniques, and standards including expert knowledge of cGMP standards .
• Coordination of production tasks to meet assigned schedule
• Knowledge of Liquide chromatography Operations.

• 3-5 Years – M.SC
  0.5 to 3 years - B.Tech / B.E (Chemical)
• 24/7 Shift

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.

• Carrying out dispensing activities as per applicable procedure.

Carrying out process and sampling activities during the production of Intermediate /API’s according to approved batch cards.

• Responsible for recording the observations of reaction parameters on the batch card as per approved procedure.
• Filling of all the batch cards (production cleaning) as per approved instructions.
• Ensure verification of pH meters and weigh balances as per applicable procedures.
• Maintain work procedure, safety precaution and cGMP.

Ensure housekeeping of plant and cleanliness of the equipments, update the equipmentReport accidents and irregularities at the work station to the Shift Officer.

• Extensive equipment knowledge to perform trouble shooting and root cause analysis. Develops solutions to complex problems requiring resourcefulness and creativity/innovation and ensures solutions are consistent with organization’s objectives.

• 2-4 Years - Diploma (Chemical)3-5 Years – M.SC
  0.5 to 3 years - B.Tech / B.E (Chemical)
• 24/7 Shifts

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.

• Excellent communication and with hands on experience.

• Having working experience of analytical method development/ validation for HPLC/GC test methods, from different markets.

• Troubleshooting/OOS investigations during validations.

• Having a good knowledge of HPLC, IR, UV, KF Titrator, Halogen Moisture analyzer, Polarimeter and wet analysis

• Having good knowledge of HPLC trouble shooting.

• Sound knowledge of Organic Chemistry & Spectroscopy.

• Having a good knowledge of HPLC Method development of API/RM/KSM and SM using various detector like Mass, IR, CAD, ELSD, UV-PDA and UV.

• Structure elucidation and Identification and characterization of APIs, known and unknown impurities

• and intermediates by various spectroscopy techniques.

• Data interpretation by NMR, Mass Spectrometer, DSC, TGA & FTIR

• Having a sound knowledge of Analytical method validation.

• Hands on experience of various Analytical Instruments-Coulometer, FT-IR, UV, Karl Fisher, Halogen Moisture Analyzer etc., >sound knowledge of Organic Chemistry & Spectroscopy.

• MSc (Organic chemistry/Analytical chemistry)

• 4- 7 years

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.

Regularly generate and deep-dive analyze Costing processes, variance analysis, Annual Operating Plan (AOP), Latest Best Estimation (LBE), month-end reporting & presentation, monitor Cost of Raw Materials and Production, Diagnose the Cause of Inventory Variance, Stock take variance analysis (PV), Create and Archive Monthly Journal Entries. Responsible for review and analysis of inventory transactions to ensure integrity of inventory value, COGS, and inventory adjustments & provisioning. Developed analysis tools to enhance review of changes to part cost, purchase price variance, to ensure accurate financial reporting of inventory.

Communication and (internal) stakeholder management with higher management levels within the Global Teva organization is required in this process.

• Technical/functional knowledge in Costing, Inventory, Accounting and closing & reporting process area, with strong background of USGAAP
• Managing all Costing & inventory related activities including accounting policies and memos, cost accounting and write offs, their reporting and balance sheet reconciliations.
• Full responsibility for the initial set-up and carve in of all Costing & inventory accounting activities into the Global Business Services. Therefore tight communication and collaboration with local, regional and global accounting teams where needed
• Supervise and oversee the group’s Costing / Inventory and cost of goods sold journal entries
• Be fully accountable for all the Costing processes & Inventory accounting activities- plan, report, ageing, provisions, monitor and analyze
• Responsible for tight alignment with local accounting and operations as well as procurement and supply chain
• Coordination of SOX compliance work for all entities and create further awareness of importance of SOX compliance
• Driving Standardization of processes and implementing of Best practices
• Support of external and internal audit requests by providing inventory analyses
• Management of day-to-day operations and coaching of the team members
• Support and lead of complex and international ad-hoc projects and ad-hoc reporting
• Support systems implementation and modification to existing system and ensure timely delivery of all system testing and validation.
• Process documentations and certifications – will have to ensure that all process are appropriately documented and periodically certified by team members on regular basis.
• Build and strengthen client relationships to achieve long-term partnerships
  

• Qualified CMA with minimum 10+ years of experience in Costing and Inventory.
• Minimum 4 years as people management experience is must
• Manufacturing experience is must
• Strong knowledge of US-GAAP and SOX
• SAP & excel experience is must
• IT Literacy- SAP, Oracle or any other ERP, Microsoft Office, Hyperion
• Well versed with latest trends, technology & best practices in the industry
• Experience in fast-paced multinational matrix organization
• Strong change management, communication and influencing skills
• Excellent listening, negotiation and presentation skills
• Fluent verbal and written communication in English
• Hands-on and proactive; strong organizational skills
• Results driven and service oriented to internal and external customers

Associate Director Finance Operations

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.