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6.0 - 9.0 years

13 - 18 Lacs

gurugram

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Department Procurement Location Gurgaon, India Reports To Head of Supplier Relationship Manager Level Grade 5 We are proud to have been helping our clients build better financial futures for over 50 years. How have we achieved this? By working together - and supporting each other - all over the world. So, join our team and feel like youre part of something bigger. About the team Fidelity Internationals Global Procurement function provides Source to Pay and Third Party Risk Management services to FIL colleagues globally. It comprises approximately 95 colleagues, based across UK, India, Continental Europe, and Asia Pacific, overseeing spend of ~$700m in 26 countries. The existing SRM function ...

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4.0 - 8.0 years

0 Lacs

andhra pradesh

On-site

Role Overview: You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of various documents such as URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ, and risk assessments. Your role will involve managing FAT and SAT for new projects, reviewing raw data and test reports, and preparing final summary reports. You will also be responsible for protocols and reports for validation processes, initiating CRNs, implementing CAPAs, and conducting incident investigations. Additionally, you will prepare and review VMP, provide training, update SOPs, and assist in inspections. Key Responsibilities: - Preparation, review, and execution of qual...

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5.0 - 15.0 years

0 Lacs

indore, madhya pradesh

On-site

As a Process Incharge for Injectable manufacturing projects, your role will involve reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval. You will verify process equipment instruments according to PI&D and electrical drawings for commissioning. Additionally, you will conduct FAT for process equipment when necessary and provide support for installation and commissioning activities. Key Responsibilities: - Verify process equipment instruments based on PI&D and electrical drawings - Conduct FAT for process equipment when required - Provide support for installation & commissioning activities - Assist in qualification activities for ...

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2.0 - 6.0 years

0 Lacs

indore, madhya pradesh

On-site

As a Document Controller at SEPAM in Chennai, your role involves managing project documentation, records, and communication tasks related to document management. Key Responsibilities: - Hands-on experience in GMP, Equipment Qualification, DQ/IQ/OQ/PQ - Experience in FMCG projects - Proficient in Document Management and Project Documentation - Skilled in Documentation and Records Management - Strong communication skills - Attention to detail and organizational skills - Proficiency in document control software - Ability to work effectively in a team environment Qualifications Required: - Bachelor's degree in a relevant field Note: Additional details about the company are not provided in the jo...

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18.0 - 20.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Industry: Pharmaceutical / Biologics / Injectables Experience: 18+ years About the Role We are seeking a dynamic engineering leader to oversee strategic project execution, equipment reliability, and regulatory compliance across injectable and biologics manufacturing facilities. This role plays a pivotal part in ensuring seamless alignment between engineering and manufacturing operations while driving continuous improvement and audit readiness . Key Responsibilities Lead end-to-end project deliveries design, installation, commissioning & qualification Manage engineering operations, maintenance, and utilities (clean & black) Align Capex & Opex budgets with manufacturing goals Ensure compliance...

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0.0 - 3.0 years

2 - 5 Lacs

nagar

Work from Office

Skills: sales, customer service, Business Development, fresher, associate, executive,. Skills Required:Excellent English communication skills No Technical/Sales skills required Strong Interpersonal skills Adaptive and quick learner Good, smooth, calm, enthusiastic communicator Designation:Process Associate/ Sr. Process Associate Location:WORK FROM OFFICE:Sector 74, Mohali Working Hours:Fixed Shift Timings (US Shift) with Saturday/Sunday Fixed Off Qualification:Any Graduate/ Diploma **FRESHERS with EXECELLENT communication skills may also apply**. Range is 15k-22k inhand and above that we have daily based incentives + 5 days working (sat sun fixed off). Show more Show less

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7.0 - 12.0 years

2 - 6 Lacs

vapi

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Responsibilities: Monitor manufacturing and packaging processes, including line clearance and in-process checks (IPQA) Manage documentation activities, including DOC-QMS systems, SOP preparation, deviation handling, and change control Support Technology Transfer (TT) activities by reviewing protocols, executing processes, and coordinating between R&D and manufacturing teams Ensure compliance with 21 CFR Part 11 requirements through validated software systems for electronic records and signatures Execute equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities Utilize automated quality systems and digital platforms for manufacturing documentation Mainta...

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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 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Veeva Safety Application Development SME, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ...

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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 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Veeva Application Development SME, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure ...

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15.0 - 25.0 years

10 - 14 Lacs

chandigarh, dadra & nagar haveli, bengaluru

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We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

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8.0 - 13.0 years

10 - 14 Lacs

hyderabad

Hybrid

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

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1.0 - 6.0 years

4 - 9 Lacs

ahmedabad

Work from Office

Responsibilities: * Collaborate with cross-functional teams on equipment qualifications & CSV. * Ensure compliance with 21 CFR Part 11, IQ/OQ/PQ procedures. * Manage validation projects from planning to closure. Flexi working Work from home Over time allowance Travel allowance Food allowance Health insurance Annual bonus Retention bonus Job/soft skill training

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7.0 - 10.0 years

8 - 18 Lacs

hyderabad

Work from Office

THERANYM BIOLOGICS PRIVATE LIMITED Title: Job Responsibilities/Descriptions Qualification: B.E/Diploma in Electrical & Position: Assistant Manager/Dy.Manager- Instrumentation 1No electronics/Instrumentation with 7/10 Years exp . Job Responsibilities/Descriptions 1. Experience in Bio-pharmaceutical Instrumentation Projects / Maintenance 2. At least 5 years handling Experience on Biosimilar / Vaccines Manufacturing Facilities or Consulting firms. 3. Hands on Experience on BMS / EMS /UMS systems installation, commissioning &qualification 4. Hands on Experience on Bio Process Equipment Instrumentation. 5. Preparation, Review of Process Instruments technical specifications. 6. Responsible for rev...

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4.0 - 8.0 years

0 Lacs

indore, madhya pradesh

On-site

As an experienced candidate with 4-5 years in validation documentation, you will be responsible for preparing Machine DQ, IQ, OQ, PQ, operational manuals, and all supporting documents in accordance with customer requirements. Key Responsibilities: - Minimum 4-5 years of experience in validation documentation - Preparation of Machine DQ, IQ, OQ, PQ, operational manuals, and supporting documents as per customer requirements Qualifications Required: - Relevant experience in validation documentation - Strong attention to detail - Ability to work in compliance with customer requirements The company offers the following benefits: - Cell phone reimbursement - Food provided - Internet reimbursement ...

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8.0 - 10.0 years

16 - 20 Lacs

hyderabad

Work from Office

Design Manager - HME( hot melt extrusion) / Continuous Manufacturing Division Job Summary: We are seeking a highly motivated and technically proficient Design Manager HME / Continuous Manufacturing Division to lead the design and development of Hot Melt Extrusion (HME) and continuous pharmaceutical processing systems . This role involves managing the end-to-end design function, ensuring technically sound, compliant, and innovative solutions tailored to the pharmaceutical, food and life sciences sectors. The ideal candidate will have hands-on experience in the design of advanced processing equipment, and a strong understanding of GMP and continuous manufacturing concepts. Key Responsibilities...

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3.0 - 8.0 years

2 - 6 Lacs

hyderabad

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We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...

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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...

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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 5+ years of IT experience with signif...

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12.0 - 16.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Quality Control Compliance Reviewer at Amneal, you will be responsible for ensuring cGMP compliance in the QC laboratory. Your key responsibilities include: - Reviewing the completeness of analytical documents and approving the Certificate of Analysis (CoA) for Raw materials, packaging materials, In-process, finished products, stability studies for submission, validation, and commercial batches. - Performing/reviewing investigations for Quality issues such as Out of Specification (OOS), Deviations, Incidents, Corrective and Preventive Actions (CAPAs) related to laboratory. - Ensuring implementation of CAPAs recommended in OOS, Out of Alert Limits (OOAL), Incidents, and deviations in the...

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2.0 - 6.0 years

0 Lacs

maharashtra

On-site

As a DQ, IQ & OQ Qualifications professional, your primary responsibilities will include: - Preparing operation & installation manuals - Developing SOPs and Work Instructions specifically tailored for the Pharma & Food Industry - Creating maintenance manuals Qualifications required for this role include: - Experience in DQ, IQ & OQ Qualifications - Strong technical writing skills - Familiarity with the Pharma & Food Industry This is a full-time position with benefits including paid sick time and Provident Fund. The work location is in person.,

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2.0 - 4.0 years

2 - 2 Lacs

vasai

Work from Office

We are looking for a Junior Engineer with strong technical expertise in Mechanical Engineering or Production Technology . The ideal candidate should have hands-on experience in AutoCAD, SolidWorks, and the use of various measuring instruments. The role involves inspections, machine trials, and preparation of essential qualification documents. Key Responsibilities: Inspection of incoming parts to ensure quality standards Create 2D/3D drawings as per project requirements Prepare qualification documents for machines Conduct inspection & trials of machines Maintain accurate inspection reports for machines Skills & Software Knowledge: Proficient in AutoCAD and SolidWorks Strong knowledge of Micro...

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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...

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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...

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1.0 - 3.0 years

0 Lacs

indore, madhya pradesh, india

On-site

Skills: GAMP 5, 21 CFR Part 11, IQ, OQ, PQ, CSV, Immediate Hiring | Computer System Validation (CSV) Pharma Industry Were looking for passionate professionals to join our team in the Computer System Validation (CSV) role. Location: Indore (M.P) Industry: Pharma Role: Computer System Validation Engineer Experience: Minimum 1 year (in Pharma domain preferred) Notice Period: Immediate Joiners to 30 days Key Responsibilities & Skills Preparation and execution of Validation Deliverables in accordance with GAMP5 and 21 CFR Part 11 guidelines. Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ, and validation of manufacturing systems (SCADA, HMI, PLC). Conduct and document Computer System...

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5.0 - 8.0 years

25 - 30 Lacs

mumbai

Work from Office

Your key responsibilities Technical Excellence 12+ years experience of selling cloud solutions to Enterprise customers and achieving target or equivalent experience 15+ years experience working in GPS/TMT/AMI/CHS/FS as the case may be >driving digital transformation, and/or relevant work experience (e.g., consulting, technology)OR Bachelor's Degree in Business, Technology, or related field AND 13+ years of experience working in GPS/TMT/AMI/CHS/FS as the case may be driving digital transformation, and/or relevant work experience (e.g., consulting, technology)OR Master's Degree in Business Administration Degree AND 8 + years experience working in GPS/TMT/AMI/CHS/FS as the case may be driving d...

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