Quality Sr Specialist jobs at Teva in 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

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• 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.
• Ensures timely and accurate data migration in collaboration with sites and Global IT / IT Quality
• Ensures timely review of CMC documentation in collaboration with Global R&D sites
• Defines team operating standards and ensures essential CORP and local procedures are followed based on knowledge of own discipline.
• Manages and supervises a team of up to 100 professional employees consisting of sr. managers, managers, authors reviewers and approvers.
• Is accountable for the performance and results of a teams within the function Global Quality GBS.
• Creates and adapts departmental plans and priorities to address resource and operational challenges.
• Ensures that decisions are guided by CORP policies, procedures and Global Quality´s business plan.
• Receives guidance from Senior Director Quality Strategy and Shared Services, SVP Global Quality, other Managers in Quality Strategy and Shared Services, Global R&D, Global IT, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites.

A.Review and approval of PQR’s

The owner of the function

• Review of Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products supplied by external vendors and manufactured at external manufactures
• Conduct review of (APRs) / Product Quality Reviews (PQRs) prepared by team members to ensure high quality of the reports prepared by the team.
• Recommend actions and communicate to stakeholder for identified actions as part of the review process to improve quality of products(CAPA)
• Approve Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) which do not require approval step by any other TEVA /non-TEVA stakeholder like QPs, RPs or FvPs.
• Support and guide in escalation of PQR issues and initiate and conduct meetings / telecons if required on priority.

B.Data Migration

• Ensure Data Migration is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of DM issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues of the DM team to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

C.R&D CMC Documentation
• Ensure review of CMC documents received from R&Ds is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

D.Quality Management Systems

The owner of the function

• Ensures that the local quality management system is maintained at GBS Quality function.
• Ensures that the local Quality Management System is compliant with respective regulatory guidelines and TEVA´s CORP QMS (Gap Assessments)
• Approves process of change controls and deviations
• Approves local SOP’s and its related documents.

E.Performance Management

• Monitors and compiles the KPI scores of the various business units and supports the team to improve their efficiency.
• Participates in the customers council meetings and supports the effectiveness of the councils.
• Leads or participates in the Monthly Quality Council and enhances the effectiveness and efficiency of it by suitable reports/metrices and continuous improvement.

The incumbent

• Approves Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.
• Reviews the training status of the team and regularly verifies that training was performed in time and successfully.
• Certifies trainers and self-inspectors to enable them to impart training and conduct self-inspection.

G.Miscellaneous Support

The owner of the function is responsible for

• Hiring of new Headcount and monitoring the Head count status
• Maintaining Employee Central and other relevant Master Data
• Liase with Finance related to the HC cost
• Responsible for approval of PR’s related to purchase of PQR’s.
• Review the invoicing cost involved with respect to the status.
• Approval of POs in SAP- for hiring and other requests like purchase orders for costs involved in updation of software
• Review monthly report to be presented to higher management

• More than 15 years of experience in QA / QC function in the pharmaceutical industry
• More than 5 years of experience in a managerial role
• Well-founded knowledge on worldwide cGxP regulations
• Excellent English language skills, other language skills could be helpful
• Very Good communication skills and ability to work in a matrix structure
• Very good knowledge of Computerised Systems in TEVA´s IT landscape (Track-Wise, SAP, LIMS, Global Insights, Glorya etc.)
• Good understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Mobility

VP Global Quality SMSO

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.

• 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 automations/BOTs
• Initiate, Drive NPS/PSQI Surveys and actions to improve the engagement scores/Customer experience
• 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 HRSS, thus improving the lean maturity of the HRSS teams
• Develop and drive a global CI roadmap for HR Shared Services aligned with enterprise goals
• Manage and execute complex, cross-regional CI projects using Lean, Six Sigma, and Agile methodologies
• Identify gaps and inefficiencies across key HR processes (e.g., onboarding, payroll, employee data, case management), and implement scalable solutions
• Promote CI mindset and practices across teams through coaching, training, and change enablement
• Leverage KPIs, VOC, and analytics to diagnose root causes, measure impact, and continuously monitor improvements
• Stakeholder Engagement: Partner with HR leaders, IT, Compliance, and regional teams to align priorities and ensure adoption of solutions
• Governance & Reporting: Establish governance mechanisms to track project benefits, milestones, and risk mitigations

• 10+ years of experience in HR Shared Services or Global Business Services field HR, with at least 5 years in CI or Operational Excellence roles
• University education in Finance/Science/Engineering is required
• Certified Lean Six Sigma Black Belt/Lean Expert and practical application knowledge
• Preferred Project Management Professional (PMP) certification
• Influencing and negotiation skills - Ability to get the work done with different level of stakeholders
• Fluent verbal and written communication in English
• Experience in a multinational firm or within GBS (Global Business Services) is preferred
• Hands-on and proactive; strong organizational skills
• Global mindset and ability to work across cultures and time zones
• Passion for continuous improvement, innovation, and employee experience
• Hands-on leadership style with a bias for action and outcomes
• Excellent analytical, facilitation, and communication skill
• Demonstrated ability to drive stakeholder alignment, influence leadership, and manage change in a matrixed environment

Head of HR Process Excellence

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.

• 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.

• Ensure pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise for internal and authority-related inquiries and problem-solving.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.
• Support team members with complex issues as a senior expert (especially in responsibilities 2–6).
• Lead a team of academic staff and administrative staff handling EU Labeling and support departmental leadership.

1. Department Leadership
• Organize and coordinate departmental tasks, personnel management, and planning.
• Manage budget and resource planning.
• Establish efficient internal and cross-departmental processes.
• Lead projects related to labeling, including project management.
• Review and approve SOPs for the department and overall processes.
• Support division leadership and develop strategy, principles, and guidelines.
2. Team Leadership
• Organize and coordinate team tasks, personnel management and planning.
• Plan team activities and align with other teams.
3. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update)
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.
4. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
5. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV-triggered and non-PV-triggered safety updates (e.g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
6. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
7. Mock-ups
• Coordinate creation and approval of packaging mock-ups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
8. Industry Representation

• • Participate in working groups (e.g., Medicines for Europe) to represent the company as an EU labeling expert.

• Experience: 12+ years of total experience and minimum 8 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry), ideally in Regulatory Affairs with at least 3 years of leadership experience.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a Ph.D. Additional leadership qualification is preferred.
• Other: Advanced English (spoken and written), strong MS Office skills, excellent knowledge of EU pharmaceutical law, regulatory affairs, and related legal areas. Project management experience required.

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.

• Lead the development and execution of programming deliverables using RWD sources (e.g., claims, EHR, registry) to support RWE studies and analyses.
• Partner with RWE statisticians and cross-functional study teams to align on analytical strategy and timelines, translate statistical analysis plans and protocols into efficient and reproducible analytical programs.
• Ensure compliance with internal standards, best practices, and regulatory requirements
• Support group head to recruit and build a team of RWD analysts based in India.
• Establish robust onboarding and training processes, documentation practices, and foster a continuous learning culture.
• Stay abreast of evolving big data analytical technology, with emphasis on advanced analytical tools and methods, AI/ML, process improvement and automation.

• Master’s degree or higher in Statistics, Biostatistics, Data Science, or a related quantitative field.
• Minimum 8 years of hands-on experience in programming and analytics in a pharmaceutical or healthcare research setting.
• Proven experience with RWD sources including claims, EMRs, and/or registry data.
• Prior experience managing or mentoring technical teams is preferred.