505 Trackwise Jobs - Page 4

Description Associate RA ( Module 3, CMC) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers,...

LIT Date: 15 Oct 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Title : Location IT Lead Job Grade: G9B/G10 Function: Global Information Technology Sub-function: Manufacturing & Quality IT Manager’s Job Title: RND India Cluster IT Lead Skip Level Manager’s Title: API & RND India IT Head Function Head Title: Global Chief Information Officer Location: Tandalja Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find y...

Service Delivery Manager - Manufacturing & Quality Applications Location: Chennai, India Schedule: Shift Work (Mandatory to support 24x7 or extended global operations) Role Overview The Service Delivery Manager will be responsible for leading the managed support, operations, and service delivery for critical Manufacturing (Mfg.) and Quality (GxP) IT applications, with a strong focus on MES (Manufacturing Execution Systems) and QMS (Quality Management Systems). The successful candidate will ensure high-quality Application Managed services, operational excellence, and continuous improvement for these mission-critical systems. Manufacturing domain knowledge is preferable but not mandatory. Key ...

Job Title Location IT Lead Job Grade G9B/G10 Function Global Information Technology Sub-function Manufacturing & Quality IT Manager’s Job Title RND India Cluster IT Lead Skip Level Manager’s Title API & RND India IT Head Function Head Title Global Chief Information Officer Location: Tandalja Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take c...

Greetings from Themesoft! We are looking for a Service Delivery Manager to oversee the managed services, operations, and support for Manufacturing (MES) and Quality (QMS) applications in a GxP-regulated environment. Role Overview: Lead a shift-based team in Chennai delivering L2/L3 support for Mfg. & Quality applications (MES, QMS, LIMS, EBR). Drive Incident, Problem, Change, and Release Management per ITIL best practices. Serve as the primary liaison for stakeholders and third-party vendors. Ensure compliance with GxP regulations and internal SOPs. Identify trends, root causes, and opportunities for continual service improvement. Technical Requirements: 12–18 years of IT experience , with a...

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: Are you a passionate, dedicated & detailed oriented professional, then the opportunity is for you to join our Quality Assurance Team at Zydus Takeda Healthcare Private Limited, Turbhe, Navi Mumbai - A joint venture of Zydus Lifesciences and Takeda Pharmaceuticals.: For more Company Details logon to -: https //www.takeda.com/en-in/wh...

Hands-on experience on testing tools like HP ALM, Kneat and SNOW - Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage - OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) - PAS/DCS Qualification - ISA95 High level of understanding - OT Security will be a plus. - Standalone Systems Qualifications - PAS/DCS Integrated with Manufacturing Equipment qualification. Key components of the responsibilities are as mentioned below but not limited to:  6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer Syste...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

This is a Hybrid position in Chennai Notice period - less than 30 Days (Immediate joiners preferred) Looking for an MES Support Engineer to provide hands-on technical support, maintenance, and validation for MES platforms in a regulated environment. Experience:- 6 - 12 - 18 Years Key Responsibilities: Troubleshoot and resolve MES application and integration issues. Support configuration, deployment, and validation activities. Collaborate with OT/IT teams to ensure MES system uptime and performance. Participate in incident, change, and release management processes. Key Skills: MES ( Werum, FTPS) and QMS ( Trackwise, Veeva)

The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

Management Level:07 - Manager Must have skills: Have Experience with leading MedTech solutions effectively by providing value-add to the processes, designs, methodologies, and business models Good to have skills: Have business Acumen to drive actionable outcomes for clients Possess analytical and outcome-driven approach Demonstrate a strategic Mindset to understand shape innovative, fact-based strategies and operating models Ability to communicate and present skills to share the perfect pitch with key stakeholders Have team building skills to collaborate, work and motivate teams with diverse skills and experience to achieve goals Experience: 10+ years of Industry Experience Educational Quali...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Responsible for creating and/or making formatting changes and edits to SOD draft documents based on supporting documentation from Business Units. Responsible to escalate any critical i...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for creating and/or making formatting changes and edits to SOD draft documents based on supporting documentation from Business Units. Responsible to escalate any critical ...

Position: Embedded Engr II The purpose of Embedded Engr II role is to ensure robust product quality in collaboration with Honeywell technology and business stakeholders. The role demonstrates technical leadership across multiple product subsystems and takes ownership for technical capability development and mentoring in team. Primary Responsibilities:- Uses strong domain and product knowledge to guide team to ensure completeness of deployment scenarios, use cases and user profile and built-in product quality. Responsible for product validation strategy including estimation, new methodologies, DOE, architecture risks mitigation during elaboration, automation and simulation planning. Responsib...

Role : LIMS Labware Specialist Experience : 7 - 10 years Location : Pan India Notice Period : Immediate to 15 days Key Responsibilities: Lead and support(L2/L3) LabWare LIMS development, upgrades, and implementation projects. Work across LabWare v6, v7, v8 modules including Product, LOT, EM, Stability, Lab Station, Inventory, and Sample Management. Provide expertise in LabWare ELN and Method Execution modules (v7). Troubleshoot and resolve performance issues; conduct system and application log analysis. Manage stakeholders, vendors, and IT engineering teams effectively. Handle escalations and ensure timely resolution aligned with business needs. Required Skills: Strong hands-on experience in...

Job Description: Senior Consultant Pharmaceutical QMS GxP We are seeking a highly experienced IT Consultant 10 years to lead the design and implementation of Quality Management Systems QMS in GxP regulated pharmaceutical environments This role combines deep expertise in business analysis and eQMS implementation with strong advisory capabilities in process harmonization and regulatory compliance As a key member of our Life Sciences R D consulting team you will play a pivotal role in delivering scalable compliant QMS solutions You ll lead quality initiatives facilitate cross functional workshops and help shape global quality processes aligned with regulatory standards such as ICH FDA EMA MHRA ...

Validation Specialist SGO Date: 10 Oct 2025 Location: Mohali - Information Technology Company: Sun Pharmaceutical Industries Ltd Job Title: Validation Specialist Job Grade: G11A/ G10 Function: Global Information Technology Sub-function: Manufacturing & Quality IT Manager’s Job Title: Validation Lead Skip Level Manager’s Title: Head SGO IT India Function Head Title: Global Chief Information Officer Location: Mohali Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun ...

Main responsibilities Global Quality Systems (CMS, DMS, LMS) Support manage document lifecycle, training assignments, and complaint data entry/analysis. Support administration, maintenance, and improvement of global quality systems. Support initiatives to improve complaint process efficiency, transparency, and alignment across global teams. Actively participate in site and global complaint review meetings, providing improvement insights, driving follow-up actions, and ensuring timely closure. Ensure all documents are managed and stored in compliance with regulatory requirements and company policies. Manage document lifecycle from creation, review, approval, distribution, and archiving. Devel...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Reporting to the Service Delivery Lead, GBS Global Quality, will hold responsib...

Job Title: Validation Specialist Job Grade: G11A/ G10 Function: Global Information Technology Sub-function: Manufacturing & Quality IT Manager’s Job Title: Validation Lead Skip Level Manager’s Title: Head SGO IT India Function Head Title: Global Chief Information Officer Location: Mohali Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charg...

Job Description: Senior Consultant Pharmaceutical QMS GxP We are seeking a highly experienced IT Consultant 10 years to lead the design and implementation of Quality Management Systems QMS in GxP regulated pharmaceutical environments This role combines deep expertise in business analysis and eQMS implementation with strong advisory capabilities in process harmonization and regulatory compliance As a key member of our Life Sciences R D consulting team you will play a pivotal role in delivering scalable compliant QMS solutions You ll lead quality initiatives facilitate cross functional workshops and help shape global quality processes aligned with regulatory standards such as ICH FDA EMA MHRA ...

Job Title Validation Specialist Job Grade G11A/ G10 Function Global Information Technology Sub-function Manufacturing & Quality IT Manager’s Job Title Validation Lead Skip Level Manager’s Title Head SGO IT India Function Head Title Global Chief Information Officer Location: Mohali Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and ...

Validation Lead SGO Date: 10 Oct 2025 Location: Halol 1 - Information Technology Company: Sun Pharmaceutical Industries Ltd Job Title: SGO Validation Lead Job Grade: G9B/A Function: Global Information Technology Sub-function: Manufacturing & Quality IT Manager’s Job Title: Head SGO IT India Skip Level Manager’s Title: Global Head Manufacturing & Quality IT Function Head Title: Global Chief Information Officer Location: Halol Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you ent...