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4.0 - 7.0 years
9 - 13 Lacs
bengaluru
Work from Office
About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 10+ years of IT experience with signi...
Posted 2 weeks ago
5.0 - 7.0 years
5 - 8 Lacs
navi mumbai
Work from Office
Preparation of Validation Master plan, Quality Manual & SOP’s. FAT, URS, IQ, OQ, PQ and requalification protocol and reports of all instruments, calibration and validation schedule. Email CV - hr.rabale@galentic.com Job Location -Rabale Navi Mumbai Required Candidate profile Operation of EPIQ software, DOCS IQ and Learn IQ., Review in LIMS, Review of protocol APQR, CMD, CMV, AMD, AMV, AMT& method. Issuance of MFR, Batch Manufacturing Record, Batch Filling Record, Risk
Posted 2 weeks ago
1.0 - 5.0 years
1 - 5 Lacs
bengaluru
Work from Office
Walk-in Drive @ Bangalore on 30th Nov 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles. Venue: Strides Pharma Science Ltd. (R&D office): 165/2, 3rd Main Road, Oppo. Kalyani Magnum Tech Park, JP Nagar 4th Phase, Bengaluru-560076 Open Positions Department: Maintenance Engineering (OSD)- Production & Packing Experience: 2-5 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Maintenance of RMG, FBD, Compression, Coating, Capsule filling, Blister Packing, Sachet Filling line, Bottle Packing Machines. Department: Maintenance Engineering - Projects, Utility & Civil Experience: 2-5 years Qualification: Diploma/...
Posted 2 weeks ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
As an Electrician with a Diploma qualification at Surmount Laboratories Ltd., you will be responsible for the following: - Minimum 2 to 5 years of experience required - Knowledge of HU DY System - Proficiency in Pre-balancing - Conducting Filter Cleaning Work - Handling Documentation work including IQ, OQ, PQ, DQ - Familiarity with HVAC Qualification - Maintaining Preventive main document and General documents Please note that the company details were not provided in the job description.,
Posted 3 weeks ago
10.0 - 16.0 years
25 - 32 Lacs
bengaluru
Work from Office
We are looking for highly experienced SAP QM Architects with strong techno-functional expertise to lead complex implementations and product innovation initiatives within GxP-regulated pharma, life sciences, or healthcare environments. Key Responsibilities Lead end-to-end solution design and implementation of SAP QM within S/4HANA environments. Work extensively on Inspection Planning, Sampling Procedures, Results Recording, CAPA, COA generation, Stability Management, and Quality Notifications. Drive product development, co-innovation initiatives, accelerator creation, and reusable solution components. Ensure compliance with GxP, audit trail requirements, and maintain full validation documenta...
Posted 3 weeks ago
5.0 - 7.0 years
5 - 8 Lacs
navi mumbai
Work from Office
Preparation of Validation Master plan, Quality Manual & SOP’s. FAT, URS, IQ, OQ, PQ and requalification protocol and reports of all instruments, calibration and validation schedule. Email CV - hr.rabale@galentic.com Job Location -Rabale Navi Mumbai Required Candidate profile Operation of EPIQ software, DOCS IQ and Learn IQ., Review in LIMS, Review of protocol APQR, CMD, CMV, AMD, AMV, AMT& method. Issuance of MFR, Batch Manufacturing Record,Batch Filling Record, Risk Mgt
Posted 3 weeks ago
3.0 - 4.0 years
20 - 25 Lacs
bengaluru
Work from Office
Performs the study set-up activities and the technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical studies. Assist with the technical & vendor oversight of multiple data types for one or more clinical studies Support the delivery of one or more Clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required. For studies, key responsibilities include: o Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate. o Coordinates review, revision, and approval of study specification documents (including operational requi...
Posted 3 weeks ago
1.0 - 6.0 years
2 - 4 Lacs
ahmedabad
Work from Office
We are looking for a responsible and technically strong person who can independently handle both Design Engineering work and Soft Floor coordination. The candidate must have a genuine interest in mechanical design, fabrication processes, and project execution. The role requires preparing accurate technical drawings, ensuring correct fabrication on the shop floor, checking received materials, coordinating with vendors and job workers, and maintaining proper documentation. The ideal person should be proactive, disciplined, and capable of taking full ownership of tasks with timely follow-ups, problem-solving ability, and readiness for occasional site visits. Strong communication, commitment, an...
Posted 3 weeks ago
1.0 - 6.0 years
2 - 7 Lacs
bengaluru
Work from Office
Responsible to follow EHS compliance, equipment preventive maintenance, calibration and breakdown activities. knowledge in protocols like URS, DQ, IQ, OQ, PQ. Interested candidates please sent your resumes to email id: jones.naveen@insta-pill.com Office cab/shuttle Food allowance Health insurance Annual bonus Provident fund
Posted 3 weeks ago
12.0 - 16.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Validation Specialist at our company, your role will involve ensuring that the validation system remains updated according to regulatory requirements and industry standards. You will be responsible for executing and reviewing Qualification/Re-Qualification and Validation activities for Equipment/System/Facility and Plant utilities. Your coordination with manufacturing, Engineering, and QC personnel will be crucial for the timely completion of Qualification/Validation/Re-qualification activities. Additionally, you will be preparing Standard Operating Procedures for the Quality Assurance Department and conducting sampling activities as per protocols such as Process Validation and Cleaning...
Posted 3 weeks ago
3.0 - 7.0 years
10 - 16 Lacs
noida, hyderabad, bengaluru
Hybrid
The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for leg...
Posted 3 weeks ago
5.0 - 10.0 years
7 - 17 Lacs
hyderabad, chennai, bengaluru
Hybrid
Greetings from HCL! Currently Hiring for Computer system validation JD: Proven experience in software validation in GxP environments and 21 CFR Part 11 compliance. Well experienced in IQ, OQ, and PQ protocols Prior experience of supporting ERP /SAP applications for Life Science domain customers Experience in tools like HP ALM, Jira, and Service Now Excellent in customer communication and team work Experience 5-18 years Location -Chennai/ Hyderabad/ Bangalore/Pune/ Noida Notice period - Immediate to 90 days CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Pref...
Posted 3 weeks ago
5.0 - 10.0 years
8 - 12 Lacs
pune
Work from Office
Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance Responsibilities 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 System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA...
Posted 3 weeks ago
1.0 - 6.0 years
2 - 7 Lacs
bengaluru
Work from Office
Responsible to follow EHS compliance, equipment preventive maintenance, calibration and breakdown activities. knowledge in protocols like URS, DQ, IQ, OQ, PQ. Interested candidates please sent your resumes to email id: jones.naveen@insta-pill.com Office cab/shuttle Food allowance Health insurance Annual bonus Provident fund
Posted 3 weeks ago
5.0 - 7.0 years
4 - 9 Lacs
pune
Work from Office
Perform gap assessment and conduct remediation of documents with stakeholder inputs. • Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices. •Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. •Creation/modification of process flows within the Manufacturing/Service Departments. • Development and maintenance Manufacturing/Service Work Instructions and related documents. • Creation/modification of fixtures, tooling, equipment and systems to support operations. • IQ, OQ, and PQ of fixtures, tooling, ...
Posted 3 weeks ago
3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
Role Overview: As an Officer in the manufacturing department, your primary responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to defined and approved procedures. You will be required to maintain the area and equipment in an orderly manner, ensuring compliance with cGMP requirements and maintaining a good state of repair and sanitized condition. Additionally, you will be responsible for performing online documentation as per departmental procedures and providing training on operation and cleaning SOPs to subordinates and operators. Coordination for IQ/OQ of new equipment/system and following all relevant SOPs for day-to-day ope...
Posted 4 weeks ago
6.0 - 8.0 years
3 - 7 Lacs
hyderabad
Work from Office
Department: Projects Designation: Executive- Mechanical Qualification: B.Tech. Experience: 6-8 years CTC Up to: 7 lacs Preparation of new equipment / facility specifications. Preparation of cost estimation as per project Ensure Layouts Preparation and sign off. User requirement specifications sign off. Preparation of functional requirement specifications and sign off. Preparation of Gantt charts for individual projects. Preparation of Qualifications (DQ, IQ & OQ) Preparation of Asset tagging lists in the plant as per the procedures. Installation & Erection of the Equipment and commissioning Inspection of the equipment / materials received at engineering stores. Planning, scheduling of projec...
Posted 1 month ago
10.0 - 12.0 years
0 Lacs
india
On-site
Job Description Responsibility TPM Exposure and awareness - PM, JH and KK pillars Handling Green/Brown Field Project - Plant Machinery Installation and Commissioning Process Validations - DQ,IQ,OQ and PR, RQ Sound Technical knowledge on Process equipment, Primary and Secondary Machines, Manufacturing Equipment Maintenance & Trouble shooting, spare parts management Monitor & Control Key KPIs - MTBF, MTTR, Maintenance Cost Develop team 100% compliance to EHS and Quality norms Regulatory Audits Implement & Enforce Safe Working Practices throughout the plant by adhering to all the Safety Standards developed by (MSI) My safety Index. ( Equipment Safety) Qualification & Co-ordination with internal...
Posted 1 month ago
1.0 - 4.0 years
3 - 5 Lacs
ahmedabad
Work from Office
Job Description: 1. Drive the CSV strategy / plan to achieve the validated status during project stage as per the ICT SOP. 2. Perform Risk assessment and carry out Risk based testing of Computerized System. 3. Preparation and Review of Validation deliverables such as URS, GxP, VP, Specifications documents (SDS, FS, SCS), IQ Protocols and Scripts, OQ Protocols and Scripts, PQ Protocols and Scripts, TM and VSR as per the ICT SOP. 4. Execution/Support in execution of IQ, OQ and PQ test scripts. 5. Co-ordinate with Vendor and System owner to carry out Validation activity of Computerized Systems and Software. 6. Responsible for achieving & maintaining the validated status of in scope computerized...
Posted 1 month ago
1.0 - 6.0 years
2 - 7 Lacs
bengaluru
Work from Office
Responsible to follow EHS compliance, equipment preventive maintenance, calibration and breakdown activities. knowledge in protocols like URS, DQ, IQ, OQ, PQ. Interested candidates please sent your resumes to email id: jones.naveen@insta-pill.com Office cab/shuttle Food allowance Health insurance Annual bonus Provident fund
Posted 1 month ago
4.0 - 6.0 years
4 - 5 Lacs
mumbai
Work from Office
Utilities Maint- All Electrical connections, HVAC/AHU, Water System, Air Compressor, Water System Piping, R&D, HPLC,GC, UV,SOP preparation, IQ/OQ/PQ documentation activities required for R&D. Troubleshooting, breakdown Apply - hr.ho@galentic.com. Required Candidate profile Pharmaceutical Experience Preferred. Maintenance Engineer.
Posted 1 month ago
4.0 - 8.0 years
7 - 10 Lacs
pune
Work from Office
Seeking an experienced Delivery Manager – Pharma IT & Compliance to lead CSV, IT compliance, and regulatory projects. Drive quality delivery, client engagement, and ensure GxP, 21 CFR Part 11, and GAMP 5 compliance across pharma operations.
Posted 1 month ago
7.0 - 12.0 years
5 - 10 Lacs
visakhapatnam
Work from Office
Job Title - Shift Incharge (Production) Lead and manage Shift operations through DCS/ Manual Operation as per SOPs to ensure process / equipments gives rated performance for operations efficiency. Duties & Responsibilities Shift Operations Management Operate DCS control console to coordinate and regulate process variables and utility streams according to prescribed SOPs / schedules. Coordinate the shift reliever and consult the NORMS and CPP. Operate & maintain Alarm Panel, PLC, ESD / F&G, CCTV control console to coordinate and emergency scenarios like hydrocarbon leak, fire etc. Implement Pilot trial plan, process parameters optimization, modifications / reshuffling of equipment’s with docu...
Posted 1 month ago
1.0 - 6.0 years
2 - 7 Lacs
bengaluru
Work from Office
Responsible to follow EHS compliance, equipment preventive maintenance, calibration and breakdown activities. knowledge in protocols like URS, DQ, IQ, OQ, PQ. Interested candidates please sent your resumes to email id: jones.naveen@insta-pill.com Food allowance Provident fund Health insurance Office cab/shuttle Annual bonus
Posted 1 month ago
1.0 - 5.0 years
5 - 8 Lacs
bengaluru
Work from Office
Description 1. Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. 2. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. 3. Individual contributor for Quality, Compliance, and Good Documentation Practices 4. Experienced in authoring review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace...
Posted 1 month ago
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