8 Operational Qualification Jobs

As a Senior Engineer in Gas Distribution Systems (GDS) and Fluid Systems, your role involves leading proposal and detailed engineering activities while enhancing the capability of the engineering team. You will play a crucial part in delivering top-notch technical solutions, engaging in technical discussions for business development, and establishing engineering standards within the organization. **Key Responsibilities:** - Lead the design and engineering of modular gas and liquid systems, encompassing gas generation units like N, O, H, blending, metering, blanketing, and pressure control skids. - Support the Business Development team by addressing technical queries (TQs) and offering optimized engineering solutions. - Take ownership of the development of PFDs, P&IDs, routing, layout, instrumentation, and component selection, such as valves, regulators, sensors, transmitters, and heat exchangers. - Prepare cost estimates, BOQs, and preliminary engineering documents for customer approval. - Supervise the preparation and finalization of PFDs, P&IDs, GA drawings, layouts, and routing plans. - Drive engineering excellence in mass transfer, energy transfer, and fluid control strategies. - Specify and size process equipment while ensuring compliance with relevant standards such as ASME, API, and TEMA. - Collaborate with automation, instrumentation, and electrical teams for integrated solutions. **Engineering Standards & Capability Building:** - Establish a solution library and component database for quicker turnaround times and enhanced sales support. - Recommend and develop a range of modular, standardized systems that are both repeatable and scalable. - Create engineering checklists and quality gates for project deliverables. - Mentor and train junior engineers in process design, documentation, and industry best practices. **Solution Mapping Across Market Segments:** - Analyze various industry segments including Oil & Gas, Petrochemicals, Specialty Chemicals, Fertilizers, Pharmaceuticals, Energy, Hydrogen, etc. - Identify specific process applications where the Company can provide standardized, modular solutions. - Recommend and develop a portfolio of standard systems for consistent marketing and sales across diverse projects and clients. - Guide the creation of a solution library aligned with industry needs and business expansion goals. These responsibilities will involve collaboration with external consultants for project-specific technical requirements, engaging external Subject Matter Experts (SMEs) for advanced technical capabilities, and overseeing Operational Qualification (OQ) and Performance Qualification (PQ) for manufactured systems.,

You will be responsible for preparing and reviewing validation documents such as Area Qualification for new facilities, Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Control System Qualification, commissioning, validation & re-qualification, and Revision Qualification for equipment/utilities/facilities. You will generate reports that summarize results, specifications, and acceptance criteria. Your role will also involve authoring documents in ValGenesis. In addition, you will track SOPs due for review, circulate them for comments, update comments, initiate change control, initiate ERA workflow, and follow up for execution, approval, and closure. You will prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements. Reviewing Calibration reports and updating them on a daily basis will also be part of your responsibilities. Furthermore, you will be required to prepare, track Purchase orders, update data sheets, arrange quotes for new equipment as needed, and update the required status and database for engineering activities in an Excel sheet. Initiating QAMS documents in Caliber will also be one of your tasks. Qualifications: - B.E./B. Tech Experience: - 7 to 8 Years,

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: CDMO Partner for Ophthalmic & Derma products for global markets. Position: Officer / Sr. Officer - IVRT R&D Markets: USA, Canada & ROW Products: Topical Formulations & Ophthalmic Preparations Location: Mumbai Job Profile: To carry out analysis as per work planning or based on the organizational requirement. To follow and perform all required activities in IVRT department as per Standard Operating Procedure (SOP). To follow and maintain quality service in IVRT department by enforcing periodical Quality Management system i.e. Good Laboratory Practices, Good Documentation Practices etc., while working. To perform operation and calibration of instruments and equipments as per respective SOP of instrument and equipment. To co-ordinate and support for work wherever applicable with the internal department of R&D centre, visitor, external vendors etc. To perform IVRT method development, IVRT method validation and IVRT comparison study, Analytical method development, method validation and method transfer for the project assigned by team lead / Management. To execute and complete the project work related to IVRT analysis within stipulated timeline as per organizational requirement. To prepare and review documents like Standard Operating Procedure, protocols and reports etc. related to IVRT Department. To be involve in preparation and review of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) documents (wherever applicable) for the instruments and equipments which is to be install in IVRT department. To attend the training but not limited to SOP, protocol training, safety training organized by internal department of R&D centre or external party. To follow all safety precautions while working in IVRT department and other departments of R&D centre. To upkeep of IVRT laboratory for all time audit readiness and to participate in audit work wherever required as per organizational requirement. To support in training and involve in analyst qualification work for the new joined employee in IVRT department. To follow all rules and regulations set up by the organization during work tenure. Desired Profile: M.Sc / M.Pharm (Pharmaceutical / Pharmaceutical Analysis / related discipline) with 4 to 6 years of experience in IVRT R&D for Regulated markets especially for topical and ophthalmic preparations to the pharmaceutical industries. Prior experience in IVRT method development and validation is essential. Familiarity with USFDA, Health Canada & ROW guidelines for topical dosage forms & Ophthalmic Preparations. Must have good experience in IVRT R&D as per SOP. Ensure Good Laboratory & Good Documentation Practices in IVRT department. Expertise to perform IVRT method development, IVRT method validation Should have experienced to prepare & review documents related to IVRT department. Good knowledge of preparation & review documents of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) documents in IVRT department. Must have good Audit experience in IVRT laboratory. Strong documentation, technical writing, and regulatory compliance knowledge. Good problem-solving, analytical thinking, and team collaboration skills. Recruiter Details: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722052906, 09722042906 E-Mail: career@bfrr.in Website: www.bestfitrecruitment.co.in

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Following a new opportunity, we are currently looking for a Junior Consultant: Qualification & Validation (CQV) to join our team in an onsite project at Rupnagar (Chandigarh) Location. The ideal candidate should have 2+ years of experience in a similar role and be able to review and update P&ID, prepare Qualification Documents like Validation Plan, Design Qualification, User requirement specification, Installation Qualification, Operational Qualification, Performance Qualification, System impact assessment, Functional Risk Assessment, Qualification summary report, Standard Operating Procedure (SOP), Change Control, and drafting DCS-PLC Process write up. The candidate should also be willing to travel and relocate as per project requirements anywhere in India and global locations after the project completion. An immediate joiner is required (20 Days). Location: Rupnagar (Ropar) - Punjab, near Chandigarh. As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers you the opportunity to work on international projects, enhance your skills, and engage with colleagues from around the world. If you are seeking a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.,

You will be working as a Validation Manager at EVOL ORTHO TECH located in Bengaluru, India. The company is involved in the manufacturing of knee orthopaedic implants for the Indian Market. Established as a greenfield project in 2025, EVOL ORTHO TECH is a Joint-Venture between a French and Mauritius Based Company. As a Validation Manager, you will report to the Quality & Regulatory Affairs General Manager and oversee a team of 3 members after ramp-up. The ideal candidate will hold a BE (MECHANICAL) degree or equivalent qualification. Your primary responsibilities will include managing process monitoring, material analysis tests, preparing qualification and validation files, handling process change requests, subcontractor change requests, and design change requests. You will also be responsible for audits, releasing production batches, document control, product release, managing the qualification process, projects, analysis of standards, and creating new tools. In terms of managerial responsibilities, you will act as the technical point of contact for the department, organize the team's work, ensure availability of resources, report malfunctions, ensure compliance with company rules and the quality system, provide guidance, training, participate in recruitment, monitor integration/training, communicate information, escalate problems, conduct interviews, and motivate the team. The ideal candidate should have knowledge of quality control, experience in design qualification, installation qualification, operational qualification, performance qualification, writing skills, proficiency in IT tools, fluency in English, project management experience, familiarity with CDSCO regulations, and skills such as rigor, organization, analytical ability, communication, good writing skills, management, leadership, conviction, and team spirit.,

Sr Associate IS Organizational Effectiveness RIM_PromoMats What you will do In this vital role you will coach who facilitates team with Scrum events, processes, and supports teams in delivering value for Veeva Vault Team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, handling risks and dependencies, and driving relentless improvement. The Scrum master help adapt SAFe to the organizations needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience Roles & Responsibilities: Lead and handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and product needs Collaborate with business partners, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and partners understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Stay focused on software development to ensure it meets requirements, providing proactive feedback to partners Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement Basic Qualifications: Masters degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelors degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience Functional Skills: Must-Have Skills: 6-8 years of experience working in global pharmaceutical Industry Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc. Preferred Qualifications: Proficiency in automation tools and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodologies. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.). Professional Certifications: SAFe for Teams (preferred) Veeva Vault Platform Administrator (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

What you will do Lets do this. Lets change the world. In this vital role you will be working closely with Business collaborators, Product Owner, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also demonstrates domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault. Implement test scripts to ensure system compliance with regulatory requirements and organizational standards. Identify, document, and track defects during the testing process. Collaborate with development teams to resolve defects and validate fixes. Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the VM Testing Vault to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and customers to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes. Offer ongoing support to ensure effective use of the platform. Generate reports and dashboards to monitor testing progress, defect trends, and validation status. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: Masters degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT or related field. Functional Skills: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Good-to-Have Skills: Proficiency in automation tools and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management). Experience of DevOps, Continuous Integration and Continuous Delivery methodology. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies. Professional Certifications: SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours.