98 Equipment Qualification Jobs - Page 4

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.

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Job Description Physical verification and readiness of equipment and instrument for process. Arranging the process accessories and consumables in process area before batch execution. Coordination for dispensing of raw material required for the production processes. Preparation of process, equipment and area related SOPs and EOP s. Preparation of process, area and equipment qualification/ validation protocols. Preparation and execution of various reports like process, equipment, area qualification and validation. Request and Issuance of BPR. Preparation and review of BPR. Preparation and execution of study protocols, URS as and when required Work Experience Four to Seven Years Education Masters in Biotechnology or Biochemistry B.Tech in Biotechnology or Biochemistry Competencies

business development - Warehouse PPC/BD-W/1312211 Contract Logistics PPL Head Office Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 3 - 5 years ShareApply Basic Section No. Of Openings 1 Designation Grade Assistant Manager - M3 Freshers/Experience Experience Employee Bonus One Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Contract Logistics Country India State Tamil Nadu Region Chennai Branch PPL Head Office Skills Skill Sales & Marketing Skills Communication skills Customer Data Minimum Qualification Under Graduate CERTIFICATION No data available Working Language English Hindi Tamil About The Role Person should have experience in business development warehousing business and strong customer data base. person able to convert existing customers on a faced manner. Product knowledge and communication skills are essential capable enough to achieve the targets as per the time frame -from the date of joining within three JC business conversion should take place. .

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 are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines 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 execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved 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 data engineering teams to drive validation activities and meet project deadlines. ? Track 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. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience 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: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams 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 accommodation.

Job Description : - Department - Injectable Mfg & Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 6 Education - ITI / Diploma Eng / D.Pharma / B.Pharma / M.Pharma Skill Set - Require good knowledge in Complex Skid / NDDS / Aseptic (PFS / Vials Liquid) / Autoclave/ Lyopholizer / Batch Manufacturing, Sterile Secondary Packing and track and trace activity + visual inspection activity. Department - QC ( QC FG / Stability / AMV ) Position - Officer to Executive Exp - 2 to 7 Education - M.Sc / B.Pahrma / M.Pharma Skill Set - Analyst : Finished, AMV & Stability Section. knowledge of Instrument - HPLC / GC. Preferably know-how of Chromeleon Software Department - Engineering ( Plant Maintenance Sterile / Instrumentation Sterile ) Exp - 2 to 15 Position - Technician / Executive / Assistant Manager / Manager Education - Diploma Eng / ITI / B.Tech Skill Set - Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility Department - QA ( IPQA / Qualification (Sterile Background Only) Position - Officer to Executive Exp - 2 to 7 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Have good exposure in Sterile IPQA & Sterile Qualification Related activity Department - Lab QA Position - Officer to Sr. Executive Exp - 2 to 9 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Having good exposure of QC QMS handling , Lab instrumentation & audit trails. Have strong background of Lab QA activity. Department - Solid Oral Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 5 Education - ITI / Diploma Eng / D.Pharma / B.Pharma Skill Set - Require good knowledge in Primary & Secondary Packing, Track & Trace, Carton Packing Machine (CAM HV1 Model), Online Documentation BPCR / Logbook etc.

To perform and Bioburden test for water, raw material, and Product. Media Preparation required for utility and area monitoring. Sub Culturing, serial dilution of standard cultures and GPT. Environmental Monitoring of all classified areas Operation of decontamination autoclave. To perform SAP and LIMS related transactions as per authorization. To perform Submission and request of records on Doc cell. Preparation and review of Microbiology related SOP s/STP s/Validation protocol and Report. To initiate Change control, Deviation and CAPA related to Microbiology as per QAMS authorization. To monitor temperature data of incubators in Lisaline. To ensure online documentation as per GMP requirement. To perform sterility Testing of RM, PM and Product. To perform Cell bank testing. To perform stability aliquoting To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site. Preparation of Microbial Library for in house isolate identified from water and environmental monitoring samples. To perform cell banking system. Daily pH, Balance Calibration and Temperature recording. Cleaning and disinfection of the controlled areas. Sink cleaning. Equipment qualification IQ/OQ/PQ/RQ and PV) / calibration activities related to Microbiology dept. Any other responsibility advised by the superiors from time to time. Work Experience 05 Years of relevant experience Education Masters in Microbiology or Biopharmaceutics Post Graduation in Microbiology Competencies 2. Innovation & Creativity 3. Customer Centricity 5. Result Orientation 6. Process Excellence 7. Collaboration

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.