278 Pq Jobs - Page 2

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...

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...

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...

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...

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, ...

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...

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...

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...

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.

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.

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...

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...

About the role The SRM will ensure that business stakeholders manage suppliers in line with risk appetite, optimising post-contract value, and developing a transparently sustainable supply base. The role holder will collaborate closely with senior stakeholders from across FIL to establish broad internal stakeholder relationships, drive value from, and manage risk across the supplier portfolio. These stakeholders include but are not limited to: senior executives across FIL; Supplier Relationship Managers (SRMs) across FIL; Supplier Risk Oversight (Procurement 2LoD function); Senior Procurement Category leaders; and risk partners across FIL. The SRM will be use experience of supplier risk and ...

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. ...

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. ...

Risk professional with proven ability to identify,assess, and mitigate operational risks across people, processes, and systems. Execute day-to-day operational risk and control management across functions. Conduct risk assessments, self-assessments, and ensure timely reporting. Track corrective actions, risk registers, and loss events with preventive action plans. Support implementation of risk programs (process, people, InfoSec, BCP, compliance, vendor & records management). Investigate incidents (fraud, security, data breaches) and identify fraud risk indicators. Analyze data for suspicious patterns and operational impacts. Drive stakeholder engagement,awareness sessions, and integration of...

Preferred candidate profile : Having 10 - 12 yrs of experience in IPQA/Documentation's in QA. Well-versed in Change control, CAPA, Deviation, Mkt complain, Validation etc. Must have working exposure in Trackwise. Candidate from OSD only. Ready to relocate Sikkim . Interested candidates may apply at hr.plant@zuventus.com

Job Role: Pharmacovigilance Tester Work Experience: 3+ years Work location: Noida, Hyderabad and Bangalore Mode of work: Hybrid Skills Required : Worked om ArisG OR Argus Safety, Functional testing and User Acceptance testing Experience in PV (Pharmacovigilance) Worked with Argus safety Or Aris tool. Experience in 21 CFR PArt 11 Functional testing and User testing Also known as OQs and PQs Manual testing (additional knowledge of SQLs is plus) Job Summary: The Argus/IVP Tester is responsible for ensuring the seamless integration, accuracy, and performance of safety data management systems, particularly in relation to Oracle Argus and IVP (Intake Validation Platform). The role involves designi...

Description: IT experience of 7 to 10 years, having experience in SAP products test management, preferably Pharma/health care compliance experience. Strong Domain test mgmt experience on any ERP platform oBased performance potential end date can go till Dec 2025 oMultiple projects in parallel and Weekly/Monthly releases oSAP operational hands-on:best practice client facing. oOpenText ALM TOSCA oGxP validation VIVA tool oReporting Governance and Follow Escalation matrix Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade :C Level :To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) :No Remote work possibility :No Global Role Family :...

Description: Skill Area:GxP Validation, Computer system Validation(CSV) Main Technology:CSV Mandatory Skills:CSV, Quality management system(QMS), Audit Handling Optional Skills:(Good to Have Skills) - Stakeholder management Roles Responsibilities:as in trail email.Key responsibilities main job The IT Validation and Compliance Partner is responsible for defining validation strategy and activities to support the Novo Nordisk S.3.01 Manage IT process. The role is applicable in several GxP and Business Critical areas such as Computerised Systems, Computerised Equipment, Infrastructure and Robotic Process Automation (RPA) as well as within Emerging Tech such as Artificial Intelligence (AI) Machin...

CSV Overall, 10 + Yrs. of experience in SAP CSV Validation Services. Developing validation strategies and plans for SAP implementations, upgrades, and modifications to ensure compliance with regulatory requirements. Conducting System GMP impact assessment, GAMP category assessment, ERES applicability assessment, Requirement/ Functional risk assessment after establishing communication with relevant stakeholders. Conducting change assessments and impact analyses to identify mandatory validation deliverables. Collaborating with cross functional teams, including IT, Business Process, CSV and Quality Assurance to ensure alignment on validation deliverables. Creation, execution, documentation, and...

Description Talent with Lifesciences domain experience with Manual testing and GxP testing skills Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade B Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills Manual tester with GXP life science Languages RequiredENGLISH Role Rarity To Be Defined

Date: 29 Oct 2025 Location: Bangalore, KA, IN, 562158 Division: Manufacturing Services Designation: Senior Executive Job Location: Bangalore Reporting to: Associate manager Job Grade: 9 (I/II) (executive 9I) (Senior executive 9II) The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene's 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-t...

Skills: CSV, 21 CFR, IQ, OQ, PQ, Computer System Validation, We are currently hiring for the position of Computer System Validation (CSV) Engineer in a reputed Pharma organization across multiple locations. Available Locations: Mandideep | Nashik | Goa | Aurangabad | Baddi | Dabhasa | Nagpur | Hyderabad (Digwal) | Indore Position Details Role: Computer System Validation (CSV) Engineer Industry: Pharma Experience: Minimum 1 year (Pharma domain preferred) Notice Period: Immediate joiners to 30 days Key Responsibilities & Skills Preparation and execution of validation deliverables as per GAMP5 and 21 CFR Part 11 guidelines. Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ, and valid...

Skills: CSV, 21 CFR, IQ, OQ, PQ, Computer System Validation, We are currently hiring for the position of Computer System Validation (CSV) Engineer in a reputed Pharma organization across multiple locations. Available Locations: Mandideep | Nashik | Goa | Aurangabad | Baddi | Dabhasa | Nagpur | Hyderabad (Digwal) | Indore Position Details Role: Computer System Validation (CSV) Engineer Industry: Pharma Experience: Minimum 1 year (Pharma domain preferred) Notice Period: Immediate joiners to 30 days Key Responsibilities & Skills Preparation and execution of validation deliverables as per GAMP5 and 21 CFR Part 11 guidelines. Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ, and valid...