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2.0 - 6.0 years
0 Lacs
indore, madhya pradesh
On-site
The Document Controller position at SEPAM in Chennai is a full-time on-site role that involves managing project documentation, records, and communication tasks related to document management. The ideal candidate should possess hands-on experience in GMP, Equipment Qualification, DQ/IQ/OQ/PQ, as well as experience in FMCG projects. Key responsibilities include document management, project documentation, and records management. The successful candidate will need to demonstrate strong communication skills, attention to detail, and organizational skills. Proficiency in document control software is essential for this role. Additionally, the ability to work effectively in a team environment is cru...
Posted 2 months ago
3.0 - 7.0 years
0 Lacs
andhra pradesh
On-site
You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ (Requirement Qualification) documents. Your responsibilities include the review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. You will be responsible for new project-related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). You will review and co...
Posted 2 months ago
3.0 - 7.0 years
0 Lacs
kolkata, west bengal
On-site
At EY, you will have the opportunity to develop a career that is as unique as you are, supported by a global network, inclusive culture, and cutting-edge technology to help you reach your full potential. Your distinctive voice and perspective are essential in contributing to EY's continuous improvement. Join our team to create an exceptional experience for yourself and contribute to building a better working world for all. We are currently seeking a Data Modeller - Senior with a solid understanding of technology and data in the data modelling space, coupled with a proven track record in project delivery. This role offers an exciting opportunity to be part of a leading firm and a growing Data...
Posted 2 months ago
3.0 - 7.0 years
0 Lacs
pune, maharashtra
On-site
At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We're looking for candidates with strong technology and data understanding in the data modeling space, with proven delivery capability. This is a fantastic opportunity to be part of a leading firm as well as a part of a growing Data and Analytics team. Your key responsibilities include employing tools and techniques used to understand and an...
Posted 3 months ago
5.0 - 10.0 years
0 Lacs
vapi, gujarat
On-site
You will be part of a greenfield project located in GIDC Vapi, covering an area of 10,556 sq m dedicated to the manufacturing of Pharma Intermediates and APIs. The project is designed to include a main intermediate production building, a GMP facility, and infrastructure for Catalytic Hydrogenation, emphasizing sustainable practices and competitive innovation. Your responsibilities will involve the preparation and upkeep of Engineering/Project documentation, Qualification & Validation documents throughout the various stages of the greenfield project until commercial manufacturing. It is essential to ensure the implementation and adherence to industry/cGMP best practices. This includes creatin...
Posted 3 months ago
3.0 - 8.0 years
0 Lacs
hyderabad, telangana
On-site
You will be joining Bigfirm as a member of the Data and Analytics team, where your primary focus will be on data modeling. In this role, you will be responsible for employing various tools and techniques to understand, analyze, collect, update, store, and exchange data effectively. Your duties will include defining and implementing data modeling and design standards, tools, best practices, and related development methodologies. Additionally, you will design, review, and maintain data models, as well as perform data analysis activities to capture data requirements and represent them visually in data models. Collaboration with data engineers will be crucial as you work closely with them to cre...
Posted 3 months ago
2.0 - 5.0 years
3 - 4 Lacs
Baska
Work from Office
Execution of IQ, OQ and PQ for new equipment, facility & utility system, report preparation and maintenance of record. Execution of Periodic performance verification activities for equipments, facility, utilities and its report preparation. Review Initial qualification master document like URS, GxP assessment, DQ, FAT, SAT, IQ, OQ, PQ and PPV of EFU system and all executed report. Handling of departmental QMS activity through track wise software, discrepancy / deficiency activity compliance of observation, summary preparation for regulatory submission. Qualification and Periodic performance verification activity execution, compilation, review of reports [Filter integrity test (PAO), air velo...
Posted 3 months ago
2.0 - 7.0 years
5 - 15 Lacs
Hyderabad
Work from Office
Title: Instrumentation and Automation Engineer Qualification: B.E in Electrical & Instrumentation Primary Responsibilities: 1. To attend /or supervise all jobs related to Instrumentation Engineering activities in site. 2. Timely execution of all calibrations of equipments/instruments as per schedule coordination with user. 3. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 4. Maintain the Spare parts of all critical Instruments in site. 5. Timely execution and completion of Validation activities to be done in site. 6. Execution of all In-house Projects in instrumentation and automation in site. 7. Maintain the calibration logs, area /equipment ...
Posted 3 months ago
18.0 - 22.0 years
20 - 30 Lacs
Mumbai
Work from Office
Role & responsibilities: 1. Responsible for overall co-ordination with all relevant stake holders from the project Team, Engineering/consultation company and SC Finish Goods Manufacturing Teams for the project delivery. 2. Preparation/Review of PFDs (Process flow diagrams) for the formulation/Standardization and downstream processes with Engineering company. 3. Best sutaible Plant Layout preparation support to Engineering company. 4. Material and Man Movement plan preparation for new SC Operations plant in co-ordination with Project Engineering and Management Team. 5. Sizing calculations for Liquid and Solid storage with internal plant vehicle Transport layout preparation. 6. Conduct design ...
Posted 3 months ago
10.0 - 16.0 years
8 - 18 Lacs
Jadcherla
Work from Office
Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, an...
Posted 3 months ago
6.0 - 10.0 years
1 - 6 Lacs
Ahmedabad
Work from Office
Preparation of Qualification documents: URS, DQ, FDS, Risk Assessment, IQ, OQ, PQ and Operation SOP of different equipment / instrument / utility. Initiation of change controls and CAPA related to Equipment / instrument / utility. Person should have hands on experience in qualification of autoclave, vial washer, depyrogenation tunnel, Filling Machine, capping machine, lyophilizer etc. Person should have exposure / understanding of qualification of packing equipment
Posted 3 months ago
6.0 - 11.0 years
4 - 6 Lacs
Pune
Work from Office
BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 4 months ago
6.0 - 11.0 years
4 - 6 Lacs
Mumbai
Work from Office
BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 4 months ago
6.0 - 11.0 years
4 - 6 Lacs
Bengaluru
Work from Office
BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 4 months ago
6.0 - 11.0 years
4 - 6 Lacs
Gandhinagar
Work from Office
BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 4 months ago
6.0 - 11.0 years
4 - 6 Lacs
Jamnagar
Work from Office
BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 4 months ago
6.0 - 11.0 years
4 - 6 Lacs
Ahmedabad
Work from Office
BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 4 months ago
7.0 - 10.0 years
7 - 11 Lacs
Boisar
Work from Office
Plan and execute preventive maintenance schedules for critical equipment (HVAC, AHUs, boilers, chillers, WFI, RO systems, autoclaves, etc.). Troubleshoot and resolve breakdowns in coordination with cross-functional teams. Support IQ/OQ/PQ of new and existing equipment. Ensure timely calibration of instruments as per the calibration schedule. Monitor and manage the operation of utilities such as purified water systems, HVAC systems, compressed air, and electrical systems. Maintain utility logbooks and ensure adherence to SOPs and GMP norms. Maintain engineering documents like machine history cards, maintenance logs, and calibration records. Ensure compliance with cGMP, FDA, WHO, and other reg...
Posted 4 months ago
0.0 - 5.0 years
4 - 8 Lacs
Visakhapatnam, Hyderabad
Work from Office
Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 2...
Posted 4 months ago
10.0 - 16.0 years
8 - 18 Lacs
Jadcherla
Work from Office
Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, an...
Posted 4 months ago
2.0 - 7.0 years
2 - 7 Lacs
Chennai, Bengaluru
Work from Office
Walk-in Drive @ Bangalore on 22nd June 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: Production Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production Department: Packing Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Bangalore Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-7 years Qualification: B.Pharm/M.Pharm/M.S...
Posted 4 months ago
0.0 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
Inviting applications for the role of Lead Consultant -Data Engineer! . Design, document & implement the data pipelines to feed data models for subsequent consumption in Snowflake using dbt, and airflow. . Ensure correctness and completeness of the data being transformed via engineering pipelines for end consumption in Analytical Dashboards. . Actively monitor and triage technical challenges in critical situations that require immediate resolution. . Evaluate viable technical solutions and share MVPs or PoCs in support of the research . Develop relationships with external stakeholders to maintain awareness of data and security issues and trends . Review work from other tech team members and ...
Posted 4 months ago
6.0 - 11.0 years
6 - 11 Lacs
Bilaspur, Uttar Pradesh, Uttar Pradesh, India
On-site
Preparation of Basic Conceptual technical Detail drawings, package for new projects Preparation of Budgetary Project Proposal with overall Cost estimation Preparation of Process Flow Diagram, PID, Equipment Layout Specification sheets of Various Equipment Overall Co-ordination with Consultants, Vendors Contractors for ordering, installation, Erection Commissioning of Equipment Plant Monitoring Project activities undersigned, reporting ensuring to complete the project within time Cost frame Commissioning of Plant get involved in trouble shooting reengineering if at all needed preparation of qualification documents (DQ/IQ OQ) and their execution after completion of project work Coordinate of C...
Posted 4 months ago
4.0 - 9.0 years
3 - 8 Lacs
Noida
Work from Office
Role & responsibilities Having experience in Pharma Plants certified by Regulatory bodies like USFDA, MHRA, EU-GMP, WHO-Geneva, etc. Candidate should have expertise in following : * Hands on experience in risk based qualification approach of pharma equipments (OSD / Sterile/ API) and clean utilities (HVAC system, WFI, PW, PSG, Compressed air, Nitrogen system etc. cleaning and process validation, * Conversant with RA, VMP, DQ, IQ, OQ, PQ document preparation and practical experience of protocol execution. * Quality Management System emeil id : hr@cgmppharmanplans.com Mobile +91 9650698486 Preferred candidate profile Perks and benefits
Posted 4 months ago
5.0 - 10.0 years
18 - 33 Lacs
Hyderabad, Chennai, Bengaluru
Hybrid
Role & responsibilities Developer/ Lead 5+ years Responsible for leading CDQ/IDMC development and delivery - Responsible for analysis, development and deploy DQ rules using CDQ. Preferred candidate profile
Posted 5 months ago
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