30 Equipment Validation Jobs

As the Quality Control Manager for injectable products, your primary responsibility is to ensure the adherence to quality control procedures in compliance with cGMP and regulatory standards such as FDA and EMA. You will oversee the testing and release of raw materials, in-process materials, and finished products, ensuring the proper documentation and traceability of quality control processes. Leading and managing the quality control team is a key aspect of your role, where you will provide mentorship, training, and motivation to ensure the team's effectiveness. Daily coordination of activities, task assignments, and setting priorities to meet production schedules are essential tasks. Regular performance evaluations and fostering continuous improvement within the team are also part of your responsibilities. You will be in charge of supervising the inspection and testing of injectable products for stability, sterility, endotoxins, potency, and other specifications. Sampling of materials and products for testing, as well as reviewing and approving laboratory test results, fall under your purview. Ensuring regulatory compliance with local and international standards, managing quality audits, and inspections by regulatory agencies, and implementing corrective and preventive actions are crucial aspects of your role. Root cause analysis of quality-related issues, initiating corrective actions, and collaborating with other departments for issue resolution are also part of your responsibilities. Overseeing the qualification and calibration of QC equipment, ensuring validation of analytical methods, and maintaining accurate documentation of test results and quality-related activities are essential tasks. Leading initiatives for continuous improvement, developing training programs for employees, and maintaining industry standards and SOPs are also key responsibilities. To qualify for this role, you should have a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related field, along with 5-8 years of experience in quality control in a pharmaceutical or injectable manufacturing environment. Strong knowledge of cGMP, FDA, EMA guidelines, laboratory testing methods, and quality management systems is required. Strong leadership, organizational, and communication skills, problem-solving abilities, and attention to detail are essential skills for this role. Proficiency in Microsoft Office and quality control software systems is also necessary. Excellent decision-making skills, interpersonal skills, and a proactive approach to quality management and compliance are personal attributes that will contribute to your success in this role.,

IQ, OQ and PQ,execution of Facility, Utility, Equipment and Computer system qualification,Client schedules,Report daily activities and work completion status to Sr. Manager, Validation ,SOPs Validation, Qualification,Calibration activities

Roles and Responsibilities Responsible to design validation/ qualification strategies. Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time. Responsible to review & approve of validation /qualification protocols and reports. Responsible for day to day validation planning and execution activity. Planning, Execution & Participation of aseptic process simulation activity. Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited. Responsible to design, review, approve and implementation of departmental standard operating procedures. Responsible to review, approval and authorization of all standard operating procedure of the site. Responsible to approve specifications, standard test procedures and analytical work records. Responsible to approve master batch manufacturing records and master batch packing records. Responsible to integrate all the standard operating procedures and to design a quality system to prevent and correct quality related subjects. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. To handle the market complaints and to participate in product recall. Responsible to perform vendor audit & approve vendor for raw materials, packing materials, contract manufacturing facilities & contract testing laboratories. Responsible to finalize annual GxP / Technical training planner as per requirement and Its Plan, execution as planner. Responsible to conduct internal audit /self-inspection to ensure compliance to cGMP and other regulatory requirements. Responsible for regulatory & customer audits preparation, execution and its compliance. Responsible to review of annual product quality review, environment monitoring trends & water systems testing trends. Responsible to co -orientate with internal as well as external department personnel to maintain the CGMP environment Responsible to update & maintain online departmental documentation. To ensure supply of products and service are having acceptable standards. To approve and authorize technical agreements from customer and outside party. To approve & authorize protocol received from outside party. Responsible to approve and authorize destruction of rejected materials/batches. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. Responsible to inform top management for future requirement of departmental up-gradation necessary for the growth of organization and to meet regulatory requirement. To ensure the implementation of quality risk management procedures. To ensure that proper implementation of data integrity policies. Responsible to approve SMF, VMP, quality manual and project validation documents & release the batch after the compliance with the specifications in absence of Senior Manager QA. Desired Candidate Profile Candidate Should have experience in Injectable plant only Good Verbal & Written skill Proficient in Ms office/Excel & Word Perks and Benefits Medical Reimbursement Subsidized Accommodation for Bachelors Professional Development Paid time off Work/life Balance

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

You will be working as a Manager Surface Treatment in a listed Automotive Company based in Pune. Your role will involve planning and developing the paint and robotic painting process along with equipment validation for 2-wheeler and commercial vehicle parts. Your responsibilities will include: - Process planning which involves designing robotic painting processes, setting robotic painting parameters, standardizing processes for sheet metal and polymer parts, and achieving PQS-CTQ points. - Developing new color paints with the aim of minimizing coats, reducing costs, and achieving shade matching and PQS-CTQ. - Exploring AI-driven processes for efficient operations. - Ensuring defect-free and quick product introductions. - Implementing process improvements to reduce costs, enhance productivity, and shorten delivery times. - Establishing fool-proof manufacturing processes by incorporating necessary Poka-Yoke/interlocks. - Enhancing product quality by studying and resolving quality issues, improving process reliability, and improving aesthetics of visible parts. - Generating value analysis/value engineering (VAVEs) to reduce part costs and avoiding unnecessary capital investments. - Implementing green processes by standardizing painting processes through documentation and exploring resource conservation. If you are interested in this role, please share your updated CV with the required details mentioned. Your expertise in planning and developing paint & robotic painting processes along with surface treatment will be evaluated based on your total experience and academic achievements. Looking forward to your application. Best Regards, Swati Phenom Placement,

Hiring for the role of Documentation Job Title: Documentation Level Executive / Sr. Executive Experience: 3-5 Years Location: Ankleshwar Job Summary: The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, and qualification of process and utility equipment. This role is ideal for mid-level professionals (3-5 years of experience) looking to advance their expertise in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment used in pharmaceutical, chemical, and food processing industries. Key Responsibilities: Prepare and maintain IQ, OQ, PQ documentation for micronizing mills, containment isolators, bulk handling systems, and fluid bed dryers. Ensure documentation aligns with industry GMP, FDA, and other regulatory standards for equipment validation. Support audits by maintaining structured records for qualification processes on day to day basis. Assist in the installation, commissioning, and qualification of high-containment and powder- handling equipment. Coordinate with internal teams and vendors for proper setup and troubleshooting of process equipment, Provide technical support for operation and maintenance of containment solutions. Work with senior engineers to troubleshoot automation systems, PLCs, and electrical components. Analyse equipment efficiency and contribute to continuous improvement initiatives. Maintain electrical consumption reports to optimize operational performance. Required Skills & Qualifications: Bachelor's degree in Engineering (Mechanical / Electrical / Chemical / Pharmaceutical) or relevant field. Hands-on experience with technical documentation processes and validation protocols. Strong understanding of process equipment installation and validation. Experience in project execution and vendor coordination. Familiarity with automation systems, PLCs, and process equipment troubleshooting. Proficiency in MS Office Suite, AutoCAD, and documentation software. If anyone is interested in this role kindly share resume to zalak.rohit@cielhr.com

Prepare Validation Master Plan(VMP, PVMP, CVMP, QMP).,Handling and storage of all quality document like BMR, BPR, log book, Protocol, Report and SOP throughout life cycle. prepare and review SOP. Monitoring of PPQ and cleaning validation activities.

You are invited to attend a walk-in interview at Zydus Biologics, Ahmedabad for the position of Warehouse Executive / FTE. As an Executive, you should possess an M.Sc./M. Com/ B.Sc. degree with 2-7 years of experience in GMP system. It is essential to have the ability to write QMS documents and demonstrate excellent knowledge of SAP, including proficiency in all T-Codes for tasks such as making GRN invoice, STO, and FG dispatches. You will be responsible for performing equipment validation and performance verification activities for the cell bank storage system, deep freezers, and temperature monitoring in the warehouse area. A solid understanding and experience in material management for raw material, consumable, API (DS), and drug product are required for this role. As a Fix Term Employee, candidates should have an HSC/ ITI qualification with 1-3 years of experience in handling and moving materials according to SOP. Responsibilities include material receiving, verification, documentation, dispensing/reconciliation of RMPM, and temperature and RH monitoring. The ability to perform cleaning activities is also essential for this position. If you are attending the interview, please remember to bring your latest resume, salary slips, CTC breakup, and all original academic documents. This opportunity is based in Ahmedabad, and the interview is scheduled for 12th July 2025 (Saturday) from 10:00 am to 3:00 pm at Zydus Biologics, Biotech Park, Opp. Ramdev Masala, Changodar Road, Ahmedabad-382213.,

Role & responsibilities Strategic Responsibilities: Define and govern the corporate CSV strategy across all units/sites for GxP systems, including SAP HANA. Lead enterprise-wide validation projects ensuring alignment with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and global data integrity expectations. Establish and monitor corporate SOPs, templates, and risk-based approaches for computer system validation. SAP HANA Specific Responsibilities: Lead validation of SAP S/4HANA (MM, QM, PP, and Z-reports, workflows, GRN process) across GxP operations. Prepare and maintain validation documentation including URS, Functional Specs, Test Scripts (IQ/OQ/PQ), RTM, and final reports for SAP HANA modules. Coordinate with IT, SAP consultants, and business users to ensure change management, role-based access control(RBAC), audit trail configuration, and secure workflows. Evaluate SAP-integrated systems (e.g.,LIMS, QMS, DMS) and their GxP compliance status. Cross-System & Governance Responsibilities: Ensure centralized control and compliance of all validated GxP systems across manufacturing, QC, QA, warehouse, and R&D operations. Conduct CSV risk assessments, gap analyses , and ensure mitigation plans are implemented across systems. Support system onboarding, upgrades, and infrastructure changes from a validation standpoint. Lead or support regulatory inspections and customer audits as CSV SME. Develop and lead training programs on computer system validation, data integrity, and regulatory compliance. Manage a team or act as a corporate mentor for site-level CSV resources. Preferred candidate profile: Technical Competencies: Strong knowledge of: SAP HANA MM, QM, PP, GRN workflows, custom Z-reports GAMP 5 / V-model SDLC / Agile methodologies 21 CFR Part 11 / EU Annex 11 / WHO / PIC/S data integrity guidance Soft Skills & Corporate Traits: Strong leadership and coordination skills for multi-site operations Excellent documentation, audit readiness, and training capabilities Capability to represent the organization in global audits and customer discussions Strong cross-functional communication with IT, QA, QC, Regulatory, and external vendors

Preparation of Qualification documents: URS, DQ, FDS, Risk Assessment, IQ, OQ, PQ and Operation SOP of different equipment / instrument / utility. Initiation of change controls and CAPA related to Equipment / instrument / utility. Person should have hands on experience in qualification of autoclave, vial washer, depyrogenation tunnel, Filling Machine, capping machine, lyophilizer etc. Person should have exposure / understanding of qualification of packing equipment

Associate - Quality Control Job Details | RadiciGroup We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Accept All Cookies Search by Keyword Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Associate - Quality Control Radici Plastics India Pvt. Ltd. RADICI PLASTICS INDIA PVT LTD is the Indian Company of High-Performance Polymers Business Unit, one of the world s leading producers of engineering plastics and a network of production and sales sites located throughout Europe, North America, South America and Asia. Associate Quality Control is responsible for ensuring the quality of production grades through online testing, sample analysis, and strict adherence to QMS protocols. The role involves maintaining and validating lab equipment, reducing QC setup time, minimizing production trials, and supporting continuous improvement initiatives. The position also oversees product audits, equipment calibration, and lab safety while coordinating cross-functional efforts for quality enhancement and efficient product development. Associate Quality Control will report directly to the Quality Control Manager. Responsibilities Ensuring the Quality of Grades/batches being produced in the Main Line Perform online testing of the quality of batches being produced and coordinate in case of a difference in expected versus actual quality Prepare all Testing and other related documents in line with QMS and maintain the same. Ensure online Sample analysis and composite sample analysis for all Production grades as per defined quality Planning Continuous Improvement towards the Setup time reduction Effective utilization of Technical Knowledge in reducing the trials in Production Reduction of B-grade generation towards the organizations target Ensure to complete the Equipment validation for all Laboratory equipment Carry out Process and Product Audit as per the Schedule Ensure all safety rules and regulations are followed during all activities Enhance lab performance through safety improvements, Kaizen initiatives, and continuous improvement suggestions; maintain a clean, organized, and efficient laboratory environment Handling the Lab Equipment Handling and Maintain all Lab equipment in good condition Monitoring and coordinate the spare parts for the lab equipment Regularly verifying the calibration of the Lab equipment Lab Equipment Validation Validate all the equipment as per the scheduled plan and verify regularly the calibration of lab equipment Technical Knowledge Knowledge of polymer compounding processes and materials; experience with polymer testing methods and procedures Knowledge of Laboratory equipment and instrumentation Understanding of Quality Management Systems Effective communication skills, both written and verbal Job Requirements Diploma/B.Sc with CIPET/B-Tech/M.Sc -Polymer /Chemical Previous experience in Plastcs sector and Compound At least 2 years of experience Office Location: Halol (Gujarat) When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitors device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another

Responsibilities: * Conduct BPR reviews, change control procedures & equipment validation. * Ensure compliance with industry standards through quality assurance processes.

Responsibilities: * Conduct BPR reviews, BMR reviews, process validation & cleaning validations. * Ensure compliance with industry standards during equipment & water validations. Accidental insurance Annual bonus Leave encashment Gratuity Provident fund

Roles and Responsibilities Conduct equipment qualification, validation, and vendor qualification activities according to established procedures. Perform process validation protocols, reports preparation, and CAPA implementation as required. Ensure compliance with regulatory requirements by maintaining accurate records of documentation and data analysis. Collaborate with cross-functional teams to identify areas for improvement in validation processes. Develop and execute test plans for new equipment installations or modifications.

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

Objective: Perform an adequate calibration operation based on SAFRAN standards as well the management of the calibration premises, tools and spare parts Role & responsibilities Follow, maintain and manage under control the tooling calibration activities as required by the related processes and requirements Perform the tooling maintenance and/or calibration per the required standards and the defined schedule Ensure external calibration tools control including related records Ensure proper tooling identification and calibration status Produce accurate and reliable calibration records and ensure its integrity Ensure proper management of calibration system/software Ensure proper tools, equipment and spare parts handling Ensure proper care and management of tools inventory under calibration, including tools integrity Ensure proper care and management of calibration spare parts Prepare documentation, charts and reports as required by the relevant processes Support operations and quality activities as required Identify and propose improvement opportunities Perform all Health, Safety & Environment(HSE) related duties as per his / her job requirements and follow HSE norms as applicable. Preferred candidate profile 2- 4 years of experience performing calibration activities is desired Experience working under ISO 9001 or AS9100 quality systems and environmental systems Professional Skills MS Office proficiency Good knowledge of Excel Basic problem-solving tools such as: Fishbone, 5 Whys, etc. Fluent English writing and speaking proficiency Behavioral Skills Work under pressure Self-motivation Team player Desirable Aspects QS Metro system Inventory management FAI knowledge SPC, ISO 9001, AS 9100, ISO 17025 knowledge

Involving in Validation of Batches and Qualifications of equipment's Carryout In process & review of all packing IPQA activity of Tablets, Capsules and soft gel area Calibration of Balance and all IPQC instruments. Ensuring that all Log sheets & Records are updated on-line Issuance and Review of BPR & SOPs with the operation. Line clearance related works before starting of production activity Equipment Qualification

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

Role & responsibilities Validation & Qualification Oversight Prepare and maintain Validation Master Plans (VMP) in alignment with corporate and regulatory guidelines. Review and approve qualification documentation including URS, DQ, IQ, OQ, PQ, RQ , ensuring completeness and compliance. Supervise execution activities and guide the team during validation and qualification stages. Oversee and review Performance Qualification (PQ) , Requalification , interim and summary reports , and addenda . Documentation & SOP Management Develop and review validation protocols , SOPs, and QA documentation related to equipment, facility, and utility qualification. Review and ensure compliance of SOPs from other departments that impact validation and qualification processes. Ensure proper documentation control, including version management and approval routing. Project Management & Execution Ensure timely completion of validation activities in alignment with project milestones and regulatory timelines. Review layouts and engineering drawings for facilities, utilities, and equipment to ensure compliance and suitability for intended use. Maintain and oversee revalidation schedules in accordance with change control and periodic review programs. Deviation & Change Control Handling Investigate and document validation-related deviations and change controls , recommending and implementing appropriate corrective and preventive actions (CAPAs) . Collaborate with cross-functional teams to resolve validation and qualification issues proactively. Training & Team Development Mentor and train QA validation team members on current practices, regulatory expectations, and internal standards. Conduct knowledge-sharing sessions to build team capability in equipment, facility, and utility validation . Compliance & Continuous Improvement Ensure cGMP compliance in all validation and qualification activities, maintaining a validated state at all times. Continuously evaluate and improve validation systems, practices, and documentation to meet evolving regulatory requirements. Preferred candidate profile Bachelors or Master’s degree in Pharmacy with 8–12 years of relevant experience in QA Validation within a regulated injectable manufacturing facility . Proven expertise in equipment / facility / utility qualification , process validation , and cleaning validation . Strong knowledge of regulatory guidelines : cGMP, 21 CFR Part 11, EU Annex 1, WHO TRS, ICH Q8-Q10. Experience in deviation handling , change control , and validation risk assessments . Ability to read and interpret engineering drawings , layouts, and P&IDs. Hands-on experience with documentation systems and quality management systems (QMS).

Role & responsibilities Sr.Executive : QMS & engineering documentation Primary Responsibilities: 1. Responsible for GMP compliance, as per procedures define and implementations of GxP practices. 2. To ensure the GDP and data integrity in routine/daily activities/operations. 3. Responsible for QMS documents related to engineering. 4. Audits & compliance 5. Preparation of SOPs, review & periodic revisions 6. To attend /or supervise all jobs related to Electrical/ Instrumentation Engineering activities at site. 7. Timely execution of equipments/instruments as per schedule coordination with user. 8. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 9. Maintain the Spare parts of all critical Instruments in site. 10. Timely execution and completion of Validation/ Qualification activities at site. 11. Execution of all In-house Projects in Electrical/ instrumentation in site. 12. Maintain the calibration logs, area /equipment logbooks, preventive maintenance schedule of all the activities. Preferred candidate profile

Role & responsibilities: Developing Validation Documentation and support for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Developing Validation Documents and Execution of Validation Protocols. Validation Documentation will encompass validation plans, specifications, test protocols and standard operation procedures. Systems include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. Preferred candidate profile Candidates must have experience/exposure to Computerized System Validation (CSV) especially PLC Validation 21 CFR Part 11, EU Annex 11 and GAMP 5. Good communication and technical writing skills are a must. Candidate should be ready to travel within Gujarat.

Responsibilities: Performing requirements analysis to develop overall testing strategy & individual test cases & protocols. Identify testing requirements & dependencies Work with relevant experts for generating testing Jigs and dependencies Performing unit testing, integration testing, and pilot unit verification and validation for all Electronic/Hardware/Embedded/Mechanical/Optical subsystems. Handle all V&V documentation including creating and maintain verification test plans & generating final reports. Work with design team to debug issues and perform root cause analysis. Coordinate with regulatory teams for identifying & performing 3rd party tests. Perform Component level validation and System level validation. Coordinate with clinical/applications specialists to complete clinical validation/evaluation/investigation as required. Preferred Skills: Strong analytical & abstract thinking, problem solving, creativity. Excellent oral, written communication skills. Prior experience participating in various activities associated with verification & validation of medical devices. Usage of test management tools including JIRA and others. Knowledge of Process Validation, Tools/Jigs/Fixtures Validation and Equipment Validation. Expertise in process & test automation and control. Comfortable with Arduino, python, Node js, C++. Comfortable interpreting PCB schematics & gerbers, drawings, & PRD. Fluency with Excel, Word, Jira, Notion.

Dear All, We are looking for as Junior Engineer - Tool & Process development for GTTC, NTTF & CIPET holders. Job Description. New child parts development (tool and process) to meet master schedule a. Tool spec review, Tool design review b. Inspection report review c. Tool Correction plan review d. Schedule review e. Handover tool and process f. Co-ordinate with CFT to get and share information related to NPD g. Develop facilities that is unique for the part ECI implementation and monitoring Adherence to IATF requirement Master list control QCPC,PCA,FMEA,SMH, gauges, fixtures, trim tools, dies, moulds, part weight, shot weight, RM details. Meet the IOC requirements given by PC Follow Safety rules Continuously improve the process by nurturing the spirit of originality, enthusiasm and innovative challenges Work in harmony within department, with other departments and vendors to solve the problems. Implement gorika. Actively participate in suggestion scheme. Interested candidates can send resume at manohara.is@trmn.biz

Role & responsibilities Validation & Qualification of Equipment Experience in Autoclave, Terminal, Sterilizer, Mixing Vessel, Tunnel Qualification, washing machine and filling machine. HVAC Qualifications Validation and qualification protocol and report. To ensure material issuance for validations activities & keep Section Manager updated. To ensure implementation of validation, qualification activities & inform to Section Manager for any deviation from written procedure. Equipment Qualification Steam Heat Sterilizer, Terminal sterilizer, Preferred candidate profile:- Result orientated Communication skills Presentation skills Analytical skills Lateral coordination * Candidate can share their resume at anee.silas@otsukapharma.in

Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: 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. 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, WHO) Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution. Provide technical input during project planning and scheduling of CQV activities. Track and report progress of CQV milestones, and support. Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures) Coordinate and interface with operations and quality assurance department, to develop supporting documentation, execution plans, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations. Initiate and manage validation deviations in the testing of development process and equipment functioning. Analyze the investigations to identify the root cause of the deviations to define a corrective action. Ensure efficient operation of the pharmaceutical equipment to corroborate the drug quality meets clients standards, GMP and FDA regulations. Perform design review to ensure the equipment is installed and operates according to the user requirement specification.