141 Equipment Qualification Jobs - Page 5

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the Job Description are to be done, as per the requirement of HOD, by following HOD s instructions and guidance. 18 Coordination and management of training activity of Manufacturing department.

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Unique Opportunity Thermo Fisher Scientific Inc. seeks a Sr Packaging/Labeling Technician to support premier packaging and labeling. Job Responsibilities Handle and perform floor level activities of secondary packaging to complete the packaging jobs within defined timelines and with the desired quality standards. Ensure that all team members technically adhere to the defined SOPs and GMP guidelines. Prepare and maintain all records and documents as per SOPs, ensuring team compliance. Support the packaging manager in change part development and the preparation, review, and implementation of SOPs. Perform FAT, IQ, OQ, PQ of equipment and prepare the necessary documentation. Operate GPMS systems to complete EBR jobs and train personnel. Face Client, Regulatory, and Internal audits successfully. Ensure that all machines and equipment in the packaging area are maintained as per desired standards. Provide operational training to new team members on SOPs and packaging activities. Lead routine activities at the floor level, seeking mentorship from the manager as needed. Support the packaging manager in preparing and reviewing functional SOPs and documents. Prepare daily, weekly, and monthly reports as required. Collaborate cross-functionally with client service departments. Support project manager for FCS label printing activities and coordinate with project teams and vendors. Plan, coordinate, complete, and report on project-related FCS label printing activities. Lead technical projects regarding software for handling the generation, printing, and inspection of clinical labels using Clinical labeling software. Qualifications B. Pharm / M.Sc.: Minimum 3 years of experience in Pharmaceutical Packaging. B.Sc. (Science): Minimum 5 years of experience in Pharmaceutical Packaging. Skills, Knowledge, and Experience Understanding of GMP and Schedule M. Knowledge of Computer Systems and GMP Documentation. Experience in handling GMP investigations. Basic knowledge of Equipment qualification. Proven team handling skills. Bring your ambition and expertise to our team and help us achieve outstanding results in packaging and labeling. Join us in our mission to make a difference!

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

Job Description Ensure readiness of equipment and instrument for process. Ensure availability of the process Raw materials, accessories and consumables in process area before batch execution. Preparation, Review of process, equipment and area related SOPs and EOPs. Preparation and execution of process, area and equipment qualification / validation protocols. Preparation of various reports like process, equipment, area qualification and validation. Preparation and Review of BPR. Request and Issuance of BPR. Preparation, Review and execution of study protocols. Readiness of downstream area and other areas like corridors and washing area etc. for manufacturing operations. To ensure smooth functioning of shop floor functions during manufacturing campaigns. To raise and review change control and deviations as per the requirement. Handling of SAP related activities like process and maintenance. Operating downstream equipments for process and CIP/SIP. 11-16 Years 11 to 16 years of experience M. Sc. /B. Tech Post Graduation B. Tech in Biotechnology or Biochemistry Biosimilar manufacturing, Production planning, QMS

Walk-in Drive @ Bangalore on 22nd June 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles. Venue: Strides Pharma Science Ltd. (R&D office): 165/2, 3rd Main Road, Oppo. Kalyani Magnum Tech Park, JP Nagar 4th Phase, Bengaluru-560076 Open Positions Department: Production Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production Department: Packing Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Bangalore Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-7 years Qualification: B.Pharm/M.Pharm/M.Sc. Job Location: Bangalore Key Skills: Analysis of Raw Material, Finished products, In Process, Stability Samples, for Capsules & Tablets with expertise in HPLC. Department: Formulation Development Experience: 4-7 years Qualification: M.Pharm Job Location: Bangalore Key Skills: Planning & Execution of Lab scale experiments. DOE, Quality by Design, Product Development, Stability Protocol, Regulatory Market. Department: Engineering Process Maintenance Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Maintenance of RMG, FBD, Compression, Coating, Capsule filling, Blister Packing, Sachet Filling line, Bottle Packing Machines. Department: Engineering Projects & Utility Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Installation, Commissioning, Equipment Qualification, DQ, IQ, OQ, PQ, Utility, Water System, HVAC, AHU, Chiller, Air Compressor, Cooling Tower, PLC, SCADA, HMI Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD

Job description 1) To prepare the Standard operating procedure for Engineering Department. 2) Operation & Maintenance of Purified Water System, UF, CSRO, HSRO, EDI & Distribution loop system 3) Operation & Maintenance of HVAC/AHU system in API Industry, Pressure balancing, Filter cleaning & area validation activity at site. 4) To prepare qualification documents DQ/IQ/OQ for the equipment to be install at site. 5) To prepare preventive maintenance schedule for the newly installed equipment. 6) To comply the Engineering related points as per cGMP & GDP practices. 7) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms. 8) To maintain discipline with co-employees & workers. 9) To initiate & implementation ideas with respect to energy conservation. 10) To allocate manpower as per work priority. 11) To ensure the critical equipment spares as availability and Co Ordinate with engineering store. 12) To maintain engineering related documents. 13) To act as training coordinator.

Job Description Officer/Executive- Packaging Development 1. Design, preparation, review and approval of documents - OPMLs, BPRs, Specifications for Packaging materials, In-house Labels and Pallet Matrix. Checking of Artworks and Shade Cards for labels, Primary Secondary packing materials. 2. Execution and coordination for SAP related activities like loading of master recipes and Bill of Materials (BOMs) for Finished Goods (FGs). 3. Conducting different Trials for Packing Materials, 4. Monitoring and technical support for execution of Packing equipment qualification/ Trial / Scale up / exhibit / commercial process validation batches on packing lines and handling of investigations, if any during the execution. 5. Handling of Deviations, Change Control, CAPA and Document Record Management. 6. To support site regulatory affairs in timely filings of exhibit products and to assist plant in regulatory inspection of customers and regulatory agencies. 7. Preparation of packaging material specifications base document. 8. Transportation study protocol/report preparation and execution of transportation study. Work Experience 2 to 5 years Education Graduation in Packaging Technology or Pharmacy Competencies Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation Creativity Result Orientation

Works independenly on creating test plans, executing tests, troubleshooting the issues, automating test cases, reporting bugs with all the required details, reviewing the tests, providing the test reports, analying test failures Capable of analyzing moderately complex challenges using analytical tools and data interpretation. Applies critical thinking to assess problems with relevant data independently to evaluate potential solutions after considering various possibilities. Engages in independent analysis and collaborates with others to gather insights and develop recommendations including challenging existing processes. Capable of working independently while actively contributing to team and organizational goals, with a growing ability to influence outcomes beyond department Incorporates and promotes new technology to improve data analysis, reporting and problem solving. Analyzes team processes to eliminate inefficiencies, leading to improved project timelines and resource allocation Contributes to department projects ; takes ownership of team projects, driving their execution and coordinating with others effectively. Recommends improvements at team level. Applies a large set of skills and knowledge effectively. Able to tailor consensual verbal and written communications that resonate with different stakeholders. Leverages network and engages independently with colleagues to achieve team goals. Shares best practices with others. Articulates and compares alternative approaches to tasks. Required education Bachelor's Degree Preferred education Bachelor's Degree Required technical and professional expertise Minimum 4 to 5 years of experience in developing automation using Python. Hands-on developing PyTest fixtures. Good exposure to writing test plans, test cases and test reports compilation Good understanding of Github, Jenkins, Jira, Test management system Good understanding of Linux, Openshift Container Platform, Kubernetes, Openshift virtualization Good exposure to VMWare, Storage concepts like virtualization, backup and restore. Excellet problem solving and troubleshooting skills Good written and oral communication skills Preferred technical and professional experience EditViewInsertFormatToolsHelp

As a QA (Quality Assurance) /Test Developer you will be designing better ways to identify potential weak spots, inefficiencies, and issues within software systems. This position will work closely with development teams and other test engineers in the implementation and delivery of software products that meet rigorous quality standards, budgets, and timelines. You will play a key role by delivering quality functions for development teams within test driven framework. Your scope will include Test Plan Development, Test Case Execution, Automation Testing, Data Creation, API Validation and incorporating test automation in the CI/CD pipelines. Your primary responsibilities include: Selenium Test Automation Proficiency: Have experience with Selenium test automation. JAVA Proficiency: Possess knowledge with JAVA programming language. API Testing and Automation Familiarity: Hands-on experience in API testing and API automation. Agile Development Methodologies: Familiarity with agile development methodologies. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 5+ years of experience. Test Planning and ExecutionDevelop comprehensive test plans and execute test cases to ensure software products meet quality standards and requirements. Automation IntegrationImplement and integrate test automation into Continuous Integration/Continuous Delivery (CI/CD) pipelines to streamline testing processes and enhance efficiency. Collaborative DevelopmentWork closely with development teams to identify potential weak spots, inefficiencies, and issues within software systems, fostering a collaborative approach to software quality. Quality AssuranceDeliver quality functions for development teams, supporting test-driven development frameworks and ensuring rigorous quality standards are met throughout the software development lifecycle. Excellent Problem-Solving Skills: Demonstrated experience in problem-solving, with the ability to tackle complex issues and find effective solutions. Preferred technical and professional experience Automation FrameworksProficiency with API testing and API automation in other Automation frameworks, such as Playwright etc. Cloud/Container skillsFamiliarity with cloud and container technologies, including Docker, Kubernetes, Red Hat OpenShift, etc. Programming LanguagesJavaScript, Jenkins, Linux, and Unix environments.

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

Develop thorough test plans and document the results and progress Develop in-depth functionality and stability automatic tests that will map customer use cases Research the right set of workloads and benchmarks Develop automated test scenarios and environments for End2End automatic evaluation Collect test evidence measurements to ensure system functionality, stability and scalability Establish automatic measures to assess the accuracy Analyze results to find ways to improve functionality coverage Analyze root causes and identify areas for improvement Collaborate with development teams to drive resolution for issues and improvement Generate test automation summary reports for stakeholders review Required education Bachelor's Degree Preferred education Bachelor's Degree Required technical and professional expertise 3-6 years of test automation development experience 2-4 years of experience in software testing in the workplace 2-4 years experience in Python/Go/Java programming Good English communication skills (written and oral) and be able to work independently and as part of a team. Knowledge of REST technologies is an important advantage. Preferred technical and professional experience Cloud network concepts including software defined networking, virtual private cloud (VPC), network services such as load balancer, firewall, gateway as it fits in cloud network infrastructure Working knowledge of cloud network infrastructure technologies Linux network internals Linux Virtualization technologies relating to network virtualization Kubernetes, Docker Knowledge of bash, go lang, php, awk Working knowledge of Network tools is an important advantage. Knowledge of Windows and Linux operating systems Knowledge of Github and Jira is an advantage. Fast learner and a team player

Lead and execute qualification test programs. Perform and execute testing in compliance with quality assurance and safety requirements. Prepare test reports using data and results obtained during testing. Work with project managers and subsystem/component leads to develop and maintain project schedules. Lead complex technical projects, coordinating multi-functional teams to accomplish project objectives while meeting established schedule and budget requirements. Support preparation of requests for quotation (RFQs) and project change offers including scope statements, specifications, costs estimate, plans and schedules. Identify and define technical issues, risks, and challenges – direct efforts to successful resolution. Comply with industry, regulatory, or agency codes and standards pertinent to equipment qualification. Collaborate with design engineers to identify design features which require qualification. Provide technical guidance, direction, and collaborate with other personnel including partners such as outside labs, sub-contractors, suppliers, fabricators, and customers. Provides consult to establish qualification strategy for product obsolescence. Collaborate with project managers to address risks, estimate cost and schedule. Train and coach other engineers Maintain nuclear safety and a safe working environment. Develop and maintain effective business relationships with Westinghouse customers. Strongly Preferred EMC Seismic Qualifications Harsh Environment Qualification Mild Environment Qualification Strongly Preferred – Testing Knowledge Equipment, Components, and Systems used in Nuclear Power Plants Control Cards Modems to Breakers, Switches Cables Instrumentation & Control Cabinets Prior experience working in lab/testing environment (academic or industry lab) Mechanical and/or electrical problem-solving skills Strong organizational, planning skills, and attention to detail Highly motivated, self-starter Good judgment and the ability to prioritize a number of diverse tasks Orientation toward achieving Customer Success Effective communication, teaming and team building skills Strong technical writing ability Ability to multitask and work on multiple projects at a time Preferred working knowledge of IEEE and Reg Guide standards for Equipment Qualification Preferred experience in the nuclear industry, specifically in nuclear power plant safety/non-safety systems with working knowledge of 10CFR50 Appendix B, NQA-1, and 10 CFR Part 21 Familiar with the below regulations and standards : IEEE 323 IEEE 344 IEEE C37.82 IEEE C37.98 IEEE C37.81 Regulatory Guide 1.180 MIL-STD-461 IEC 61000-4 EPRI 102323

Job Description 1. Qualification of process equipment, area. HVAC and Utility qualification (Compressed air, Nitrogen and PSG) and equipment qualification like Vial washing, Tunnel, Filling, Sealing and Autoclave 2. CSV validation of different category of equipment. 3. Review of CSV documents like SIA, CFRA, RAP, RAR, VA, URS, DQ, FRS, 4. CS, IQ, OQ and Qualification of water system 5. calibration / qualification / requalification / cGMP compliance of equipment / instruments / measuring devices and area on periodical basis or as and when required.

Job Description Knowledge of equipment qualification, facility qualification, CSV, QMS Review of the Equipment Qualification Protocols and Final reports and Monitoring of the Equipment Qualification like IQ, OQ and PQ. Review of Qualification documents for IQ, OQ and PQ done by the Vendor/Third party related to Instrument integrated with equipment Experience in handling of QMS related activities: Change control, Deviation, CAPA Experience in drafting of technical reports, Quality risk assessment, water trend report, Annual equipment performance review report and perform gap assessment against regulatory guideline. Review of periodic validation like, steam sterilizer validation, Thermal mapping reports, HVAC qualification, LAFU/BSC qualification Work Experience 2 to 4 Year Education Graduation Post Graduation Competencies

Job Description Responsibilities: Sterility and BET Testing: Perform sterility and Bacterial Endotoxin Testing (BET) for raw materials and products. Validation Activities: Execute validation activities. Prepare and review Microbiology-related SOPs, STPs, validation protocols, and reports. Equipment Qualification and Calibration: Conduct equipment qualification (IQ/OQ/PQ/RQ and PV). Perform calibration activities related to the Microbiology department. Change Control, Deviation, and CAPA: Initiate and manage Change Control, Deviation, and Corrective and Preventive Actions (CAPA). Bioburden Testing: Perform bioburden tests for water, raw materials, and products. Population Determination of Biological Indicators: Conduct population determination of biological indicators. Cell Bank Testing: Perform cell bank testing. Work Experience 5 to 8 year experience Education Post Graduation in Microbiology or Biotechnology Competencies Innovation Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting 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 . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.

Role & responsibilities 1. Preparation of Qualification documents for Pharmaceutical OSD Process Equipments. - URS, DQ, IQ, OQ, PQ 2. Execution of IQ, OQ & PQ of Process Equipments 3. Execution of modification projects 4. Review of Process Equipments layouts & associated utilities 5. Review of Process Equipment Vendor PFDs & PIDs 6. Preparation of URS for Process Equipment’s 7. Preparation of QRA & CR for modification projects 8. Creation of Maintenance plan, Calibration plan for Process equipment’s 9. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 10. Completion of all trainings assigned to role 11. Ensure integrity of data at workplace. 12. Ensure Good Documentation practices at workplace 13. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 14. Weekly meeting with cross functional team to meet project timeline. 15. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 16. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 17. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 18. Preparation of qualification document timely and Timely completion of project compliance action 19. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 20. Qualification documentation should prepare and execute with 100% accuracy without GXP error 21. All QMS actions should be completed within the assigned date. 22. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 23. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. company : Sando z Location : Mumbai (Kalwe Sight) share resumes to nedunuri.saikumar@manpower.co.in

Position: Manager Quality (QMS) Experience: 8 to 14 years Location: Kurla, Mumbai Qualifications: B. Pharma / M. Pharma / M.Sc (Chemistry) Shift Time : 5 PM- Midnight Work Model : Hybrid (3 WFO+ 2 WFH), later can change Industry Preference: OSD and API plant Key Responsibilities & Required Experience: In-depth knowledge of Quality Control investigations including OOS, OOT, Lab Incidents, and Deviations Expertise in Root Cause Analysis and Risk Assessment Hands-on experience with analytical instruments and various QC techniques Proficient in drafting Quality Technical Agreements (QTA) Skilled in compendia assessments , data trending , Annual Product Quality Review (APQR) Exposure to Process Validation , Cleaning Validation , and Equipment Qualification Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of our sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

Role & responsibilities USFDA Experience Production Equipment Design Knowledge & Trouble shooting methods (Mixing, Filtration, Filling, Sterilizer, Inspection, Packing) FMEA (Equipment Failure Risk Analysis) Technology Transfer from F&D-Equipment. Equipment Qualification(URS,FDS,DQ,FAT,SAT,IQ,OQ,PQ)

Kaliberr bioscience pvt ltd is looking for QA Executive to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Role & responsibilities To perform utility maintenance Equipment qualification Routine & periodic maintenance Preferred candidate profile Experience of pharma background (API / Formulation)

Roles and Responsibilities Ensure compliance with regulatory requirements, company policies, and procedures related to packaging operations. Oversee the entire packaging process from material receipt to product dispatch, ensuring quality control at every stage. Conduct regular audits and inspections to identify areas for improvement and implement corrective actions. Develop and maintain documentation of all packaging activities, including batch records, inventory management, and equipment maintenance schedules. Collaborate with cross-functional teams to resolve issues related to packaging materials, labeling, or productivity. Desired Candidate Profile 9-13 years of experience in pharmaceutical industry with expertise in managing packing processes. Bachelor's degree in Pharmacy (B.Pharma) or equivalent qualification required. Strong understanding of Good Manufacturing Practices (GMP), Current Good Manufacturing Practice (cGMP), Regulatory Affairs (RA). Proficiency in change part suitability assessment, yield monitoring, equipment qualification/validation.

Job Description : Business: Pharma Solutions Department: Engineering Location: Digwal Travel: NA Job Overview To maintain the GMP & EHS Documentation related to E&M Key Stakeholders: Internal Production, QA, EHS Key Stakeholders: External Regulatory, Customer Reporting Structure AGM - E&M Positions that report into this role Executive/ Sr. Executive / Dy. Manager Experience 12 years and above Job Description: Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Train & lead the Team Should be familiar with online GMP documentation. Should be familiar with Root cause Analysis tools. Should have in-depth knowledge on Equipment Qualification, Preventive maintenance documentation, ISO documentation, SAP knowledge. Responsible for preparation of SOP's, HVAC protocols and validation reports. Should be familiar with Change controls, Deviations, Risk assessments Should be familiar with process equipment like Reactor, centrifuge, ANFD, RCVD, Blender, sifter, multi mill, FBD etc Should be familiar with Utility equipment like Boiler, Air compressor, nitrogen plant, chillers Responsible for preparation of all types ofschedules and follow-up with user departments Responsible for Audit compliance, CAPA closing. Co-ordination with QA, production, EHS and Engineering team.