253 Oq Jobs - Page 3

Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong ...

1) Ensuring their accounts comply with the requisite audit standards 2) Providing a robust and clear perspective to audit committees and 3) Providing critical information for stakeholders. Our Service Offerings include External Audit, Financial Accounting Advisory Services (FAAS), IFRS & US GAAP conversion, IPO and other public offering, Corporate Treasury - IFRS 9 accounting & implementation support etc. Your key responsibilities Experience of working on FS clients is preferred IT audits including statutory and internal audits IT General Controls (ITGC) testing IT Application Controls (ITAC) testing / IT Automated Business Controls testing IT Infrastructure risks and control assessments IT ...

Work on consulting projects for Banks, NBFCs, AMCs, Insurance companies, DFIs and other Government agencies and support the Senior team in execution Role would involve working on lending & digital transformation, system integrations, due diligence (technology & operations), process flow design & technology cost optimization Support in Business Development activity such as Preparation of RFPs, proposals etc. Develop analytical frameworks, create and present impactful PPTs/reports to drive client solutions

Role Overview: As an Executive in the manufacturing department, your primary responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to approved procedures. You will also be in charge of maintaining the area and equipment in compliance with cGMP requirements. Additionally, you will be responsible for training subordinates on operational and cleaning procedures and coordinating IQ/OQ/PQ for new equipment/systems. Your role will involve following departmental SOPs for daily operations, handling material movement, and ensuring safety protocols are adhered to. Key Responsibilities: - Supervise manufacturing, processing, packaging, and ...

About the Role : We are looking for an SAT Faculty for Math to lead our SAT Plus program. SAT Plus is an online live learning program through which students around the world can learn from highly qualified and trained faculty. The charter for this role will include: Conducting remote SAT Quant coaching sessions for individual students via video conferencing platforms Providing detailed feedback and progress reports to students and their parents/guardians. Keeping up-to-date with SAT exam changes and trends to ensure the curriculum remains relevant and effective. Maintaining communication with students and parents/guardians to address concerns and provide support as needed. The best candidate...

About the Job The LEDP Release quality coordinator ensures adherence to Sanofi quality standards for each new release of the LEDP platform, including: Proper classification of new release (e.g. minor /major version) and adherence to related release process based on content. Right quality of documentation at each step of the development, testing and release process, as well as application support post release. LEDP is Sanofis backbone to new product development and industrialization. It establishes a data continuity between the CMC and Launch units. It enables paperless tech transfers and serves as a foundation for other digital tools such as Launch Readiness Control tower, One click TT, One ...

As a member of the Process Engineering (Instrumentation) team at Knovea Pharmaceutical Pvt. Ltd. in Indore, MP, you will play a crucial role in the pharmaceutical manufacturing industry. Your responsibilities will include: - Reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval if necessary. - Verifying process equipment instruments according to PI&D and electrical drawings for commissioning if needed. - Conducting FAT for process equipment as required and providing support for installation and commissioning activities. - Supporting qualification activities for equipment including IQ, OQ, and PQ. - Identifying all field instrumen...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP FI CO Finance Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with various teams to understand their needs, developing solutions, and ensuring that applications function effectively to support business operations. You will engage in problem-solving and decisi...

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

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 : NA Minimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will analyze and design new business processes to create the documentat...

As the leader of the DQA department, your role is to ensure the implementation of CGMP rules and regulations in Research & Development. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and communicating with R&D, ARD, QA, and Regu...

As a Senior Executive at Syngene International Ltd. in Bangalore, you will be responsible for the commissioning & qualification, and QMS activities for biopharmaceutical manufacturing facilities. Your key responsibilities will include: - Performing validation of computerized systems and Electronic Records and Electronic Signature (ERES) Validation. - Timely preparation, review, and approval of URS, DQ, IQ, OQ, and PQ protocols and reports. - Coordinating the Calibration Program, Preventive Maintenance Program, and Alarm Management for manufacturing facilities. - Conducting investigation for equipment failure, root cause identification, and implementation of appropriate CAPA. - Participating ...

In this role as an Officer, your main responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to defined and approved procedures for stability batches and commercial batches. You will need to ensure that the area and equipment are maintained in an orderly manner as per cGMP requirements, in a good state of repair, and in a sanitized condition. It is essential for you to perform online documentation in adherence to departmental procedures and maintain good documentation practices. Additionally, you will be responsible for providing training on operation and cleaning-related SOPs to all subordinates and operators. Coordinating IQ / O...

As an Assistant Manager - Quality Control in the Production department at Sky Biotech, your role will involve providing quick and on-time results to the IPQC department. Your responsibilities will include handling all documentation work related to RM, IPQC, FP, stability samples, validation, etc. Additionally, you will be in charge of executing and reviewing instrument qualification (IQ, OQ, & PQ). **Key Responsibilities:** - Provide timely and accurate results to the IPQC department - Manage documentation tasks for various processes including RM, IPQC, FP, stability samples, and validation - Execute and review instrument qualification procedures (IQ, OQ, & PQ) **Qualifications Required:** -...

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...

Role & responsibilities Job Title Manufacturing Engineer/Process Validation Engineer Location – Chennai Delivery looking immediate joiner only Conduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP). Review process controls, equipment validation, and quality systems documentation to identify non-compliances and areas for improvement. Identify systemic issues and risk areas related to manufacturing quality, process robustness, and compliance. Support remediation activities including process updates, validation efforts, documentation revisions, and training plans. Strong understanding of regulatory ...

We are looking for a skilled professional with 6-10 years of experience to join our team as a Sailpoint IDN expert. The ideal candidate will have a strong background in application development, integration, and workday management. Roles and Responsibility Design and implement Sailpoint IDN solutions for clients. Collaborate with cross-functional teams to develop and integrate applications. Provide technical expertise on Sailpoint IDN, VA, IQ Service, and Oracle HCM. Develop and maintain documentation for Sailpoint IDN implementations. Troubleshoot and resolve issues related to Sailpoint IDN and other HR systems. Work closely with stakeholders to understand business requirements and provide s...

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...

We are looking for a skilled Validation Engineer with 5 to 8 years of experience. The ideal candidate will have a strong background in validation and CSV experience, as well as knowledge of IQ, OQ, and PQ processes. Roles and Responsibility Design and develop test cases for validation purposes. Collaborate with cross-functional teams to identify and resolve issues. Develop and maintain documentation of validation processes and results. Analyze data to identify trends and areas for improvement. Participate in audits and ensure compliance with regulatory requirements. Provide training and support to junior team members. Job Requirements Bachelor's or Master's degree in Engineering (BE/BTech) o...

Experienced in preparation,execution&review of process/cleaning validation,equipment qualification,calibration, preventive maintenance, and validation schedules. Ensures effective implementation validation master file. resume to hrd@stedmanpharma.com

I am looking for a database resource for Integral IQ that is suitable for professionals with 3-6 years of experience and a strong foundation in database concepts

I am looking for a database resource for Integral IQ that is suitable for professionals with 2-4 years of experience and a strong foundation in database concepts

Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

Job Title: Computer System Validation (CSV) Specialist Regulatory Compliance & QA Location: Hyderabad Experience: 3 to 6 Years About the Role: A leading MNC is hiring skilled Computer System Validation (CSV) Specialists to support regulatory compliance, QA, and governance for validated systems and infrastructure. Key Responsibilities: Identify/manage regulatory risks (GxP, cGMP, FDA, 21 CFR Part 11) Author validation strategies, protocols, and reports (end-to-end CSV required) Execute IQ, OQ, PQ in compliance with cGMP Work with cross-functional teams: R&D, QA, IT, Manufacturing, Engineering Validate systems in Agile SDLC environments Review validation lifecycle documentation Support Change ...

As a Sr. Validation Engineer at CMIC CMO USA Corporation in Cranbury, NJ, your role involves utilizing pharmaceutical science analytics to author validation protocols in compliance with cGMP/FDA standards. You will be responsible for planning, managing, and executing start-up, commissioning, and validation of new pharmaceutical equipment. Additionally, you will draft and implement qualification protocols, resolve deviations and CAPA, prepare validation reports, develop SOPs for manufacturing and packaging equipment, as well as write test protocols. **Key Responsibilities:** - Author validation protocols in compliance with cGMP/FDA standards - Plan, manage, and execute start-up, commissioning...