251 Oq Jobs

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...

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 ...

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 ...

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...

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

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

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...

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 ...

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...

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...

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...

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...

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...

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.,

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...

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...

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...

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...

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...

Requisition Id 1650367 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that its your career and Its yours to build which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity Senior Consultant-FS-SaT-SaT - S&E - Corporate Strategy - Mumbai...

The opportunity We have new opportunities for ambitious individuals to join our Tax Team. You will receive extensive training and support from a variety of leading tax professionals to assist you in building a successful career in Tax service line within EY. Your key responsibilities Your client responsibilities Review of tax returns, tax provisions, and work papers. Review of audit of tax deliverables prepared by tax analysts / advanced tax analysts. Act as first level reviewers of products that are finally reviewed by the engagement teams, thus acting in the role equivalent to a counter part in the Ireland. Successfully monitor the engagement team against the plan and budget. Adhere to the...

Your key responsibilities Spanish / Portuguese language knowledge Experience in GBS set up activities such as activity analysis, cost baselining, Location assessment, Business case creation, Target Model design, etc. Working knowledge of GBS / SSC setup engagements. Know-how of the Business Transition assignments and related activities Experience / knowledge around finance functions in at least two domains Record to report (RTR), Procure to pay (PTP), Order to cash (OTC) or FP&A This includes experience around Account Reconciliations, Journals, Transaction matching, Variance analysis, intercompany and Fixed assets accounting / management Strong accounting skills and understands financial rep...

At EY, youll 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 were 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. LevelSAP FS-CD Staff Consultant Experience1-2 Years Need to assess, design, and develop a working SAP FSCD solution for our global clients. Business requirements management on the Insurance Business process, translate functional requirements into solution design, Design of functional and technical concepts in SAP FSCD Interact and communicate w...

Bachelor’s degree in engineering or science discipline, or equivalent experience. A minimum of 5 to 10 years of experience in establishing and maintaining regulated supplier management systems. Experience with APQP (IQ,OQ,PQ) preferred. Technical writing of protocols and reports. Experience in ISO 9001, 13485 a plus. Engineer quality and ensure compliance for raw materials, components, finished products etc. Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage. Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized L...

The Opportunity We are seeking a highly skilled, motivated and operationally strong QA Manager to lead a team of engineers. In this role, you will not only oversee managing a dedicated QA team but also own and drive end to end qualifications of multiple releases. In this role, you would be responsible for all aspects of Quality Assurance at Nutanix, from setting up test strategies and processes to managing qualification of all product releases to building a world class QA team. About the Team At Identity & Access Management, we are trying to build the next-generation IAM to help enterprises & internal clients. Your Role Develop a deep understanding of the product, both from a customer's pers...