253 Oq Jobs - Page 5

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. ...

Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on ...

Your Role Design and implement SAP solutions tailored to the unique regulatory and operational needs of the life sciences industry. Collaborate with R&D, manufacturing, quality, and compliance teams to align SAP systems with GxP and FDA/EMA requirements. Lead SAP S/4HANA implementations across pharmaceutical, biotech, and medical device domains. Ensure integration of SAP with lab systems (e.g., LIMS), MES, and serialization platforms. Drive digital transformation initiatives focused on traceability, patient safety, and operational efficiency. Your Profile 12-16 years of experience in SAP, with a strong focus on life sciences industry processes and compliance. Expertise in SAP S/4HANA, SAP AT...

About The Role We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders. Key Responsibilities:- MBR Design & Development: Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes. Analyze site-specific requirements and translate them into functional MBRs. Validate MBRs for deployment across manufacturi...

Deloitte is looking for Deputy Manager | CSV | | SAP to join our dynamic team and embark on a rewarding career journey Assist the Manager in the day-to-day operations of the business, including setting goals, developing strategies, and overseeing the work of team members Take on leadership responsibilities as needed, including managing team members and making decisions in the absence of the Manager Identify and address problems or challenges within the business, and develop and implement solutions Collaborate with other departments and teams to ensure smooth and efficient operations Maintain accurate records and documentation Contribute to the development and implementation of business plans...

Role & responsibilities .Department - Production (Fill-Finish) Jr. Operator / Operator / Sr. Operator Job Description: Depyrogenation, HPHV Steam Sterilizer, Production related activities, Lyophilizer, Vial filling & Sealing machine operations & Formulation activities Experience: 1 - 6 years Qualification: ITI/Diploma/B. Sc/Equivalent Job Description: Officer / Executive /Jr Executive Production plan, filling activities, cGMP, SOP, Preventive maintenance, Lyophilizer, Aseptic Media fills, HPHV, Handling Filter integrities, DQ, IQ, PQ, OQ. Experience: 1 - 6 years Qualification B. Pharmacy / M. Pharmacy What should you carry 1. Updated resume 2. Latest increment letter with last three months p...

1. Understanding various SDLC (Agile, Waterfall, V) 2. Analyze requirements, perform impact analysis, and regression analysis, and communicate with stakeholders on the need for changes in requirements. 3. Strong experience in Manual and Exploratory Testing. 4. Good experience with various testing types like Functional, Regression, UI/ Usability, Integration testing, etc., 5. Idea on Generative AI for testing 6. Good experience in various testing techniques. 7. Experience in testing and test planning of CI/CD-based solutions through tools like Azure DevOps. 8. Experience in Programming (Java/Python etc.,). 9. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,.). 10. Autom...

Ensure accurate and timely processing of invoices and monitor incoming payments. Manage and oversee the daily operations of the AR department including invoice processing, payment processing, and account reconciliation. Knowledge of TDS & GST. Secure revenue by verifying and posting receipts and resolving any discrepancies. Maintain accurate records and control reports for all AR transactions. Use accounting software and MS Excel to process business transactions and compile reports. Collaborate with other departments to ensure billing accuracy. Address and respond to customer inquiries regarding invoices and payments. Ensure compliance with accounting principles and company procedures. Parti...

As an Advanced Engineer for Process Automation at NNE, you will play a crucial role in providing innovative solutions in life science and pharmaceutical projects. Your responsibilities will include developing functional specifications, coding DCS applications, conducting peer reviews, coordinating with cross-functional teams, testing and verifying functionality, and ensuring commissioning and qualification meet regulatory standards. You will collaborate with a diverse team of engineers across project phases, demonstrate expertise in specific areas, and contribute to technical solutions within and across teams. With a minimum of 5 years of experience in a similar role, you will be part of the...

Job Title: CQV Engineer Location: Bangalore Experience: 3-4 years in pharma CQV 1. Commissioning Activities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. 2. Qualification and Validation: Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WH...

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies ...

As a Process Incharge - Injectable, you will be responsible for overseeing formulation manufacturing projects with an experience requirement of 12-15+ years, including 5-6 years specifically in formulation manufacturing projects. Your key responsibilities will include reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval when necessary. You will be tasked with verifying process equipment instruments in alignment with PI&D and electrical drawings, ensuring commissioning of instruments as needed, and conducting Factory Acceptance Tests (FAT) for process equipment where necessary. Additionally, you will provide support for installat...

The Document Controller position at SEPAM in Chennai is a full-time on-site role that involves managing project documentation, records, and communication tasks related to document management. The ideal candidate should possess hands-on experience in GMP, Equipment Qualification, DQ/IQ/OQ/PQ, as well as experience in FMCG projects. Key responsibilities include document management, project documentation, and records management. The successful candidate will need to demonstrate strong communication skills, attention to detail, and organizational skills. Proficiency in document control software is essential for this role. Additionally, the ability to work effectively in a team environment is cru...

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company ...

You will be responsible for leading the execution of the SICR strategy at our organization by building and nurturing a highly capable and scalable team. Your role will involve challenging divisional processes to drive high-yield, cross-divisional outcomes. In addition, you will drive thorough SICR scrubbing to capture all relevant details, challenge suppliers, and maximize service, quality, and cost benefits. Coaching and developing subject matter champions to actively shape process improvements and ensure compliance with Stryker procedures will also be a key aspect of your responsibilities. Regularly reviewing SICR aging reports, collaborating with sourcing to cancel or deny cases with obso...

You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ (Requirement Qualification) documents. Your responsibilities include the review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. You will be responsible for new project-related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). You will review and co...

• Execute product/prototype testing as per SOP/WI and protocols. • Prepare specimens, samples, and test equipment setup. Record, interpret, and analyze data; prepare test reports. Required Candidate profile Operate and maintain lab equipment; perform calibration and maintenance activities. Ensure strict compliance with safety procedures, GLP, GDP, and 5S standards

As an experienced professional with over 10 years of expertise in Lab Vantage LIMS, you will be proficient in working with tools such as bartender, executing SQL queries, and managing CSV deliverables. Your role will involve conducting CSV activities including IQ, OQ, and PQ, while gaining hands-on experience in SaaS environments, with a preference for Lab Vantage. Responsibilities: - Working on bartender - Executing SQL queries - Managing CSV deliverables - Conducting CSV activities such as IQ, OQ, and PQ - Gaining hands-on experience in SaaS environments Qualifications: - Experience with Lab Vantage LIMS Required Skills: - Good knowledge of CSV deliverables - Good knowledge of CSV activiti...

Role & responsibilities Must be aware of regulatory guideline like 21 CFR part 11, EUannex 11, GAMP 5 etc.. Must know about GAP assessment Must have exp in handling CSV of L1 , L2 system like DAS, DCS, Empower ,OSD /injectable Mfg equipment Must have knowledge for performing category 4 and 5 system Preparation and execution of validation deliverables like IRA,VP, URS,FS, CS, DS, FRA, IQ, OQ, TM, VSR Execution of qualification document without DI

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...

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...

Position : Executive Engineering QMS Qualification : BE Mechanical/ Electrical/ Instrumentation or B pharma preferably BE Experience : 6-7 years experience in handling engineering department GMP documentation activities and supporting engineering function as SME in QMS documentation Responsibilities : 1.Implementation of quality assurance standards, processes, controls and cGMP in warehouse. 2. Preparation of SOPs and ensure effective implementation. 3. should be well versed with deviation management SOP 4. Should be well versed with change control and CAPA management related to engineering department 5. Should be familiar with documentation like DQ, IQ, OQ and PQ. 6. To ensure that training...

Job Description Summary The Qualification Expert for Analytical Instrumentation is responsible for ensuring the accuracy and reliability of analytical instrumentation used in various scientific processes. They will be responsible for assessing and verifying the qualifications of these instruments, as well as documenting and maintaining the records. Job Description Major accountabilities: Perform qualification assessments on analytical instruments to ensure compliance with regulatory requirements and industry standards. Develop and execute qualification protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), for analytical inst...

• IT Infrastructure Management: Overseeing the management of IT and OT infrastructure, including hardware, software, networks, and data centers. Ensuring the availability, reliability, and security of IT systems. Ensuring minimal downtime and optimal performance. • System Performance: Ensure the reliability and availability of IT and OT systems and applications critical to manufacturing processes as per business requirements. • Security and Compliance: Ensure IT and OT systems and processes comply with industry regulations and standards, such as FDA, EMA, and GMP. • Disaster Recovery: Develop and maintain disaster recovery and business continuity plans to minimize downtime and data loss in c...

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards . Accountabilities Interfaces with customers and vendors representing company...