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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 2 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 2 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 regulatory guidelines. Assist in new equipment installation and facility modifications. Coordinate with vendors and contractors for engineering projects.
Posted 2 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 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.
Posted 2 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, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience
Posted 2 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.Sc. Job Location: Bangalore Key Skills: Analysis of Raw Material, Finished products, In Process, Stability Samples, for Capsules & Tablets with expertise in HPLC. Department: Formulation Development Experience: 4-7 years Qualification: M.Pharm Job Location: Bangalore Key Skills: Planning & Execution of Lab scale experiments. DOE, Quality by Design, Product Development, Stability Protocol, Regulatory Market. Department: Engineering Process Maintenance Experience: 2-7 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: Engineering Projects & Utility Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Installation, Commissioning, Equipment Qualification, DQ, IQ, OQ, PQ, Utility, Water System, HVAC, AHU, Chiller, Air Compressor, Cooling Tower, PLC, SCADA, HMI Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD
Posted 3 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 provide feedback for growth . Implement Data Performance and data security policies that align with governance objectives and regulatory requirements . Effectively mentor and develop your team members . You have experience in data warehousing, data modeling, and the building of data engineering pipelines. . You are well versed in data engineering methods, such as ETL and ELT techniques through scripting and/or tooling. . You are good at analyzing performance bottlenecks and providing enhancement recommendations you have a passion for customer service and a desire to learn and grow as a professional and a technologist. . Strong analytical skills related to working with structured, semi-structured, and unstructured datasets. . Collaborating with product owners to identify requirements, define desired and deliver trusted results. . Building processes supporting data transformation, data structures, metadata, dependency, and workload management. . In this role, SQL is heavily focused. An ideal candidate must have hands-on experience with SQL database design. Plus, Python. . Demonstrably deep understanding of SQL (level: advanced) and analytical data warehouses (Snowflake preferred). . Demonstrated ability to write new code i.e., well-documented and stored in a version control system (we use GitHub & Bitbucket) . Extremely talented in applying SCD, CDC, and DQ/DV framework. . Familiar with JIRA & Confluence. . Must have exposure to technologies such as dbt, Apache airflow, and Snowflake. . Desire to continually keep up with advancements in data engineering practices. Qualifications we seek in you! Minimum qualifications: Essential Education Bachelor%27s degree or equivalent combination of education and experience. Bachelor%27s degree in information science, data management, computer science or related field preferred. Essential Experience & Job Requirements . IT experience with a major focus on data warehouse/database-related projects . Must have exposure to technologies such as dbt, Apache Airflow, and Snowflake. . Experience in other data platforms: Oracle, SQL Server, MDM, etc . Expertise in writing SQL and database objects - Stored procedures, functions, and views. Hands-on experience in ETL/ELT and data security, SQL performance optimization and job orchestration tools and technologies e.g., dbt, APIs, Apache Airflow, etc. . Experience in data modeling and relational database design . Well-versed in applying SCD, CDC, and DQ/DV framework. . Demonstrate ability to write new code i.e., well-documented and stored in a version control system (we use GitHub & Bitbucket) . Good to have experience with Cloud Platforms such as AWS, Azure, GCP and Snowflake . Good to have strong programming/ scripting skills (Python, PowerShell, etc.) . Experience working with agile methodologies (Scrum, Kanban) and Meta Scrum with cross-functional teams (Product Owners, Scrum Master, Architects, and data SMEs) o Excellent written, and oral communication and presentation skills to present architecture, features, and solution recommendations Global functional product portfolio technical leaders (Finance, HR, Marketing, Legal, Risk, IT), product owners, functional area teams across levels o Global Data Product Portfolio Management & teams (Enterprise Data Model, Data Catalog, Master Data Management) Preferred Qualifications Knowledge of AWS cloud, and Python is a plus. . . . . . .
Posted 3 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 Clean room conceptualization of Class 1000 to 100000 for finished product related HVAC system for Powder Processing areas Interdepartmental co-ordination for successful completion of projects Review Approval of P IDs, Layouts and qualification documents related to equipment and critical systems Analysis and reporting for current and expected cash flow required in the Project maintaining records of all drawings (PID layouts)
Posted 3 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 3 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 3 months ago
7.0 - 10.0 years
12 - 15 Lacs
Pune, Bengaluru
Hybrid
DQ,DL,DM, Data Analysis, Data Mapping , Collibra Introduction: As a Data Lineage Analyst, you will play a crucial role in enhancing the transparency and understanding of data flow within our organization. This position is ideal for someone who is passionate about data management, data quality, and governance and seeks to leverage these skills to drive meaningful insights that influence strategic decisions. Key Responsibilities: Analyze and Document Data Lineage: Track data elements from their origin through various transformations to their final form, documenting the data flow and any processes that impact data. Improve Data Quality: Identify areas where data quality can be improved and collaborate with data governance and IT teams to implement enhancements. Collaborate on Data Management Policies: Work with data governance teams to develop guidelines and policies that ensure data accuracy and consistency across the organization. Stakeholder Engagement: Regularly engage with business and technical stakeholders to gather requirements and provide updates on data lineage projects. Tool Implementation: Utilize and help to implement tools and technologies designed to automate and facilitate data lineage tracking and reporting. Data Mapping and Metadata Management: Create and maintain mappings of data sources, transformations, and consumers, along with metadata to support data lineage. Troubleshoot Data Issues: Identify and resolve issues related to data flow and lineage in collaboration with data engineering teams. Qualifications: Bachelors degree in information technology, Computer Science, Data Science, or a related field. Proven experience in a data-focused role, preferably with specific experience in data lineage, data analysis, or data governance.
Posted 3 months ago
2 - 4 years
0 - 1 Lacs
Navi Mumbai
Work from Office
Qualification : Bachelor's degree in a related field or equivalent work experience. Years of experience : 1 to 4 Years relevant experience Required skills : Proven experience in technical document control or a related field. Strong knowledge of document management software and tools. Attention to detail and the ability to work with complex technical documents. Familiarity with project management Familiarity with industry standards and regulations related to documentation. Roles & Responsibilities Manage and control all technical documents, including engineering drawings, manuals, specifications, and procedures Ensure that all technical documentation adheres to regulatory and quality standards. Facilitate the retrieval of technical documentation Collaborate with subject matter experts to review and validate technical documents Ensure that all technical documentation adheres to regulatory and quality standards.
Posted 4 months ago
2 - 7 years
1 - 4 Lacs
Bharuch, Ankleshwar, Karjan
Work from Office
To get GA drawing approval from client in consultation with V TOP& Marketing Execute DQ. Documentation of project,tracking &reporting of project status report Update Brahma& reports, collect all reports like kick off Updating Drawing approval report Required Candidate profile Co-coordinating with factory & marketing team Co-ordination of activities between design, planning, material production and vendor management Keeping track of short supplies Updating PLC FDS
Posted 4 months ago
- 5 years
4 - 8 Lacs
Visakhapatnam, Hyderabad/Secunderabad
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 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.
Posted 4 months ago
2.0 - 7.0 years
3 - 6 Lacs
ahmedabad
Work from Office
Job Description QA-Qualification Injectable /Parenteral (Officer/Senior Officer/ Executive) Job Location Sanand, Ahmedabad (Injectable Facility) No of Position - 03 Total Experience - 2-7 Years in Injectable Manufacturing Education B. Pharmacy/M. Pharmacy Will appreciate immediate joiner for this role Oversight and Governance QA ensures that all qualification activities (DQ, IQ, OQ, PQ) follow Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., US FDA, EU GMP, WHO). Participates in project planning for qualification activities. Reviews and approves Qualification Master Plan (QMP). Document Review and Approval: QA is responsible for reviewing and approving all qualification documentation: Design Qualification (DQ): Ensures the design of equipment/facility meets regulatory and user requirements. Installation Qualification (IQ): Verifies that equipment and systems are installed as per specifications. Operational Qualification (OQ): Ensures equipment operates within defined parameters. Performance Qualification (PQ): Confirms equipment consistently performs under routine conditions using real products or simulations. Change Control and Deviation Management Evaluates and approves change controls related to equipment or facility qualification. Investigates and approves resolution for deviations arising during qualification. Ensures CAPA (Corrective and Preventive Actions) are effective and documented. Material and Component Qualification : Ensures that raw materials, primary packaging materials (vials, stoppers, syringes), and excipients are qualified and sourced from approved suppliers. Environmental and Utility Qualification Oversees the qualification of: HVAC systems Cleanrooms (classified areas) Water systems (WFI, PW) Compressed gases Ensures compliance with microbiological and particulate limits. Sterility Assurance QA is heavily involved in qualifying systems that ensure sterility: Sterilizers (autoclaves, dry heat ovens) Aseptic filling lines Depyrogenation tunnels Isolators and RABS Data Integrity and Traceability Ensures that qualification activities are well documented. Verifies compliance with data integrity standards (e.g., ALCOA+ principles). Ensures audit trails for electronic systems. Requalification and Periodic Review QA defines and approves the requalification frequency. Monitors ongoing performance trends to determine if requalification is needed. Final Release/Approval QA provides the final sign-off for qualified systems or equipment before they are released for GMP use. Ensures all required documentation is complete, accurate, and archived. Interested candidates are can apply on Darpana: 9978604075 OR can email me on darpana@upman.in
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