Thermo Fisher is seeking a new colleague who is passionate about customer experience, is technologically savvy, and has a passion for the digitization of science. The vision of Digital Science Solutions is to make it easy for scientific customers to digitize their research, development, and manufacturing lab operations. The Technical Consultant will be responsible for providing guidance, support, and implementation services related to Digital Sciences Solutions products such as LIMS, ELN, LES, SDMS, and other enterprise applications. You will work closely with clients to understand their laboratory processes and requirements, design solutions, perform system implementation tasks, and provide ongoing support and training to users. Your experience in configuration, data management, laboratory workflows, and regulatory compliance will contribute to the successful implementation and utilization of Digital Sciences solutions in various laboratory environments. Essential Duties and Responsibilities: Strategic: Trusted advisor to our customers, global account managers, services leaders, product managers, and delivery teams. Maintain and assume accountability for a culture of high customer service. Position Thermo Fisher Digital Science as a leader in life and laboratory science digitalization through successful delivery. Work with broader organization to achieve business objectives, expand multi-functional client engagements. Effectively share knowledge to help build a world-class digital solutions consulting and implementation team, working closely with global services leaders. Provide feedback to product management and engineering to rapidly advance our product capabilities to meet customer needs and expectations. Contribute to 3rd party technology, product, and solution evaluations in the context of our portfolio. Operational: Collaborate with clients, business analysts, project managers, and solution architects to understand their laboratory information management needs, workflows, and regulatory compliance requirements. Develop and document comprehensive solutions based on the gathered requirements, including system configuration, customizations, and integration with other laboratory systems. Participate in the implementation of enterprise laboratory solutions, ensuring that they are configured and customized correctly to meet client specifications and industry standard methodologies. Define data management strategies, including data mapping, migration, and validation, to ensure accurate and reliable data entry, storage, and retrieval within the solution. Assess laboratory workflows and find opportunities for process improvement and automation. Develop and execute test plans to ensure the system meets functional and performance requirements. Conduct user training sessions and provide ongoing support to laboratory staff, addressing questions, resolving issues, and ensuring effective system utilization. Prepare detailed user documentation, including system requirements, design specifications, user manuals, and standard operating procedures (SOPs). Work closely with multi-functional teams, including software developers, quality assurance analysts, and laboratory personnel, fostering effective collaboration and communication. Remain current with relevant industry regulations and guidelines (eg, FDA, ISO) and ensure that the implemented solutions align with these standards. Contribute to improving processes, ensuring compliance, and driving improvements. Provide recommendations into planning, resource allocation, management, tracking, and reporting on all aspects of customer engagements. Participate in team and customer meetings delivering engaging, informative presentations both to internal and external audiences. Travel, as needed, for internal and customer meetings. Culture: In line with the 4I values of Integrity, Intensity, Innovation, and Involvement, that form the foundation of the Thermo Fisher culture and ways of working, this role will bring intensity, innovation, and a high degree of involvement to designing, proposing, and delivering on Digital Science platform solutions. Business Partnership: Working collaboratively with Digital Science and broader Thermo Fisher colleagues to create and sustain a culture of delivering excellent customer experience, embracing continuous learning, leading with digital innovation, analytical thinking, and managing complexity. Knowledge, Skills, and Abilities Knowledge of enterprise laboratory software platforms, such as LIMS, ELN, LES, SDMS, CDS, or similar systems. Understanding of laboratory processes, data management principles, and laboratory workflows in various domains (eg, pharmaceutical, biotechnology, manufacturing). Familiarity with regulatory requirements and compliance standards relevant to laboratory operations (eg, FDA 21 CFR Part 11, ISO 17025, GLP, GMP). Experience with relational databases - Oracle, SQL Server, Postgres. Knowledge of cloud services and infrastructure highly desirable. Excellent problem-solving skills and ability to analyze complex business requirements and translate them into solutions. Demonstrated experience delivering in a matrix, global environment, across internal and external resources. Understanding of IT processes, SDLC methodologies, Quality Management Systems, and knowledge of regulatory landscape, with preference for experience in delivering and supporting validated systems. Superb communication and interpersonal skills, integrity, and credibility. Results focused, with attention to detail and a concern for quality. Planning, prioritizing, reporting, problem solving and analytical capabilities. Collaborative, initiates and facilitates communications and relevant information sharing, and works with different functions to achieve the best outcomes. Ability to exercise judgment and discretion concerning critical, confidential, and proprietary information. Flexibility in work schedule to accommodate communications with global team. Able to innovate and bring ideas forward and advance issues and risks in a positive way. Minimum Education and Experience Requirements Bachelor s or masters degree in IT, IS, Engineering, Life Sciences, or equivalent. At least 2-5 years of relevant experience in life sciences technical and business consulting with medium and large customers in the life and laboratory sciences industry, specifically, developing and deploying solutions catering to one or more areas of discovery, research, development, or manufacturing.

Job Title: Executive/Sr Executive Job Grade (refer to JE) G12A/G11B Function: IT Location: Baroda Areas Of Responsibility List of Responsibilities / Job function: To work as per cGMP and ensure its compliance as per current guideline and SOPs. Instrument application support with help of respective system vendors. To ensure the Laboratory Software are validated as per defined Global Procedures. To perform the assigned activities in the role of Technical Owner/System Administrator, and also performs software validation of new/existing instruments in laboratory in the role of Technical Owner and System Administrator as per requirement. Responsible for User Creation\ Modification \Deactivation\ Reactivation in Lab system as per UAM. Responsible for Preparing Active user list & periodic user access review of computerized system. To maintain and secure 21 CFR part 11 compliance of Software / instrument / Equipment available in laboratory. Responsible to take training before execution of allotted work & maintaining the training file. Responsible for securing the Login/ Passwords as Administrator of software/ instrument/ Equipment available in Labs. Responsible to follow Quality Management Document procedure. Time synchronization of standalone balances Project Backup & Restoration activities for software s in Lab systems. Responsible for execution of Installation, qualification and validation of systems. Responsibility to Support user for application related issue with the help of vendor. Responsible to inform reporting authority for any non-compliance/event occur during execution of GMP activities. Responsible to escalate quality related issues to management and resources requirement. Responsible as Administrative rights holder for Software/instrument/Equipment available in CAL, ADD, ADD-Development & PE Laboratory. To prepare and implement the CS\CSAP related to system control policy & user management for Laboratory Software. Support to Audit trail review activity for all GxP systems Support to perform Periodic User access review and Privileges verification for GxP systems Responsible for project creation\lockelock and unlock in respective application e. g. Empower, Chromeleon, Mass lynx, Lab Solution, XRD, Spectrum, POL, tem etc. Coordinate with Site QA IT and CQ IT for compliance of computer system quality management as per GSOPs. Remote Application support as and when required. Other job responsibilities assigned by reporting authority. Responsible for ADD-IT Department for Log book Issuance as per requirement. Travel Estimate Job Scope Job Requirements Educational Qualification Degree in Electronics & Communication Engineering Experience 6+ Skill (Functional & Behavioural): Technical & Conceptual skill Creativity and Innovation Basic knowledge of MS office (Word, Excel & Power point) Behavioral Competencies / Soft Skills: Effective communication skill Flexibility Empathetic, Integrity & Time management Listening skills Learning from other The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. Strategize, submit and obtain approvals from CDSCO i.e., FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. Strategize, submit and obtain approvals from State FDA i.e., Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. Strategize, submit and obtain approvals from CBN, i.e., Export Authorizations and Import Authorizations. Additionally, must have knowledge about FSSAI registration and licenses. Ensure that regulatory strategies are implemented, timely review and alignment with CFTs including R&D, Quality Unit, Manufacturing, Supply Chain and Marketing team. Work closely with R&D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. Well versed about the online portals i.e., Sugam, NSWS, IDML, IFP, Unified CBN and FOSCOS portal. He/She should be able to handle the queries raised by the aforesaid government department. Need to possess good communication.

Design and specify process equipment systems for pharmaceutical manufacturing plants, ensuring alignment with the project goals and regulatory standards (e.g., GMP, FDA, EMA). Select appropriate equipment, considering factors such as material compatibility, process requirements, automation, and cost-effectiveness. Develop equipment specifications, datasheets, and technical documentation for procurement and installation. Having hands on experience for installing isolator-based filling line. Line manufacturer is Bausch + Straubel, Syntegon, Steriline. Lead or support the execution of process equipment projects, including installation, commissioning, and qualification. Develop project plans, timelines, and budgets for equipment-related projects, ensuring the completion of all milestones on time and within scope. Coordinate with external vendors, suppliers, and contractors to ensure timely delivery and installation of process equipment. Oversee the installation and commissioning of new equipment and systems, ensuring smooth integration into existing operations.

Responsible for commercial batch release to market. Responsible for in process Quality Assurance activities. Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components. Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for Sampling & compilation of Process Validation Reports (PVRs) Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Good Documentation recording and updation. Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs). Responsible for the routine GMP Inspection & review of Quality Records of other departments. Responsible for monitoring in Aseptic process simulation study. Responsible for Preparation and Compilation of Media Fill Protocol , Report. Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation. Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas Responsible for preparation and implementation of SOPs Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule. Responsible for personnel monitoring. Responsible to participate in qualification, requalification, area qualification activities. Activities other than in the Job responsibility are to be done as per requirement of HOD.

Roles and Responsibilities (Hiring for AQA Role, IPQA Role, QMS Role - API Background is Must) Ensure compliance with GMP, BMR, BPR, SOPs, and quality systems. To Perform Analytical QA Role IPQA Activities QMS Activities Validation Activities Collaborate with cross-functional teams to ensure timely completion tasks Person Should be from the API Background

*Experience in production operations in Intermediate 1 API industry, Equipment & Utility Operations, Filing BMR I BPR, Distillation Process, having exposure of handling CF, Multi-Milling, AGNFD, FBD equipment. Required Candidate profile * Experience of working in API industry I Bulk Drug, having exposure of handling and preparation of Production cGMP documentation, Change Control, Deviation, 005 Investigation and CAPA etc.

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

Role & responsibilities Supervision and monitoring of work in BB line particularly for Mixing, Filling and pouching as per respective SOP and maintaining discipline in work area. In process monitoring to check quality of product at each stage of process and provide on job training to concern workers. Maintaining and hygiene condition in clean room as per respective SOP. On line documentation as per requirement. Ensure timely availability of material for smooth production. Weighing and checking of raw material as per requirement. Ensuring Smooth material Flow for timely availability of material of semi finish good machine and equipment at each stage of process. Maintaining identification status of process, material, semi finish good, machine and equipment at each stage of process. Monitoring of rejection at various stage of process and analyze it and reduce it by effective monitoring, analyzing and eliminating the root cause. Ensuring timely and efficient execution of production targets. To take prompt action for any break down maintenance as well as preventive maintenance of machines and equipment. Maintaining inner department coordination as per requirement.

Role & responsibilities Relevant Experience : Should have experience of Production for Formulation Plant of Oral Solids (Tablets, granules, powder) & Allied in PHARMACEUTICAL COMPANY / FACTORY. FDA Approval in Tablet Section Pharma Formulation plant would be preferred. 1. Batch Manufacturing Manufacture production batches as per Batch Manufacturing Record (BMR) and Batch Production Record (BPR). 2. BMR/BPR Documentation Complete the online BMR and BPR as per the respective activities. 3. Coordination with QA Coordinate with the Quality Assurance (QA) department for the issuance of monthly formats. 4. Manufacturing Parameters Review Review parameters during manufacturing stages such as compression, filling, and packing for oral dosage products. 5. SOPs and Documentation Prepare, update, and maintain Standard Operating Procedures (SOPs), BMR, and BPR documents. 6. Document Maintenance Ensure proper maintenance of documents, including BMR, BPR, cleaning records, calibration logs, environmental records, and equipment usage logbooks. 7. Manpower Allocation Allocate and manage manpower for the effective utilization of resources. 8. Production and Packing Oversight Oversee and manage the overall manufacturing and packing activities in the oral department. 9. Compliance with cGMP & GDP Monitor and implement Current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) within the department. 10. Quality Management System: Handle the Quality Management System (QMS), including initiating, investigating, and completing change control, deviations, and incidents. 11. Equipment & Area Qualification: Monitor and review equipment and area qualification activities and ensure timely reporting. 12. Validation Activities Coordinate with QA and QC departments for product process validation and cleaning validation activities. 13. Production Target Achievement Ensure daily and monthly production output targets are achieved. 14. Cross-Department Coordination Facilitate coordination between Quality Assurance, Quality Control, Warehouse, and Engineering departments. 15. Material Availability Check Ensure availability of required raw materials (RM) and packaging materials (PM) as per the production plan and schedule. 16. Training & Development Conduct training programs on SOPs, GMP, technical procedures, and identify training needs for department personnel. 17. BMR/BPR Handover to QA Ensure completed BMR and BPR are handed over to the QA department before dispatch activities. Required Candidate profile: 1. 07-10 years of experience in Formulation Pharmaceutical Plant. 2. Relevant Experience in Pharma formulation plant. 3. Computer proficiency in MS Office, Excel, e-mail and internet functions, ERP

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and pharmaceutical products using techniques such as HPLC, GC, and method validation. Perform stability studies to ensure compliance with GMP guidelines. Calibrate instruments accurately and maintain records of instrument maintenance schedules. Ensure accurate documentation of test results, reports, and certificates of analysis. Collaborate with cross-functional teams to resolve quality issues. Only male candidates

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; . Strong understanding of Good Manufacturing Practices (cGMP), Current Good Laboratory Practice (cGLP), and International Organization for Standardization (ISO). Proficiency in handling chemicals safely according to OSHA regulations.

Role & responsibilities Operate Tetra Pak machines, including A3, filling machines, and carbonation systems. Ensure proper cleaning and sanitizing of equipment to maintain HACCP standards. Perform preventive maintenance tasks to minimize downtime and optimize machine performance. Troubleshoot issues with machinery and resolve problems efficiently. Maintain accurate records of production runs, quality control checks, and maintenance activities. Record production data downtime, and machine performance in the logbook or system. Ensure packaging materials ( caps,straws, cartons) are available and correctly loaded. Collaborated with maintenance and quality teams to resolve issues quickly. Participate in root cause analysis and continuous improvement initiatives. Preferred candidate profile 5-10 years of experience in operating Tetra Pak machines or similar beverage processing equipment. Diploma/B.Tech/B.E. degree in relevant field (e.g., Chemical Engineering). Strong understanding of GMP guidelines and ISO standards for food safety protocols. Proficiency in preventative maintenance practices to reduce downtime and increase efficiency. Interested candidates can reach out to us at 7838204667 Contact Person Somi Ghosh HR- Manager

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Key Roles/Responsibilities: Method Development of different drug product Routine analysis of development samples and lab stability samples GMP batch analysis, Stability batch analysis and reporting Peer review for the routine experiment PDLIMS data entry Analysis of raw material and packaging material Validation of analytical methods Calibration and maintenance of analytical instruments Preparation of tentative test procedures for routine development analysis, method development, method validation report and standard test procedure Follow GxP (GMP, GDP etc) for all processes Following in-house compliance system Maintain hygienic condition in respective department. Ensure use of Personal Protective Equipment & attend EHS training & send waste to concerned person & comply EHS requirements Refrigerator temperature monitoring and maintenance. Ensure data integrity Qualifications M.Sc. (Analytical Chemistry)/ M.Pharm (Quality Assurance/Pharmaceutical Analysis)

Qualification : IIP/CIPET/PGD in Packaging Experience : 4 to 7 years Job Summary: In line with business strategy, develop and introduce new packaging solutions that satisfy the consumer, customer. Work closely with the cross-functional teams in order to effectively deliver new, fit for use packaging solutions to the business. To support the Product Development and Process Managers throughout the launch procedure. Use prior experience to lead and supervise all aspects of packaging of various food and food grade verittes. This includes overseeing overall packaging strategy, scheduling, compliance with FSSAI, EU & USFDA regulations, record-keeping. Manage and develop cost saving initiatives in conjunction with the procurement team Oversee all finished goods labeling, filling, packaging, and case sealing procedures in an efficient manner that also complies with state regulations, GMPs, SOPs, and all applicable packaging procedures Supervise Packaging Associates as part of a high-performance team. - Assist in preparing reports, planning budgets, setting production schedules, pricing products, and making packaging decisions based on estimated consumer demand, sales data, and industry knowledge. Work with the procurement team on the rationalization of materials. Trouble shooting existing products implementing corrective actions plans. Identify and recommend changes to systems and processes as appropriate. Support to cross-functional project teams on all packaging related issues Establish and manage supplier relationships. Provide packaging solutions for new products, range re-launches and range extensions Generate and manage the packaging critical path in conjunction & the NPD Development. Direct, participate in and drive packaging trials on production lines.. Liaise with the Process team on post-trial tasks, e.g. re-heat instructions, organoleptic, freeze suitability, QAS.. Work with the Process team on pre-production runs, ensuring customer approval of packaging Where appropriate conduct alternative supplier evaluation trials Follow risk management procedures Review of transit trials with the process team and Basic packaging specification management, including checking the quality of information Ensure that all packaging for new products meets with customer and business expectations whilst adhering to legislative, quality, safety and environmental standards. Ensure all packaging for new products achieves manufacturing performance by providing cost effective solutions. Management of packaging samples throughout the process, ensuring blanks are available for product trials and printed packaging is available for pre-production. Sign off of artwork with the site team

What are the Key Deliverables in this role? Financial Outcomes Cost of poor quality & wastage reduction : Develop evaluation metrics and tracking cost of poor quality across 3P manufacturing units. Take proactive measures to reduce FG rejections and product recalls. Customer Service Customer/Consumer Complaints : Monitor customer and consumer complaints regularly. Contact the customer to understand the complaint in detail and provide clarification regarding the process, product, and nature of the issue. For genuine complaints, prepare a detailed root cause analysis along with a mitigation plan. Internal Processes Q&FS Score, Analytical Compliance of Product & Packaging to FSSAI standard, GMP : Planning and testing of plant internal sample at external lab and review RFT on Monthly basis and Necessary Continuous Improvement Plan to Failures (if any), Monitor the Variance between Internal & External Testing results. Implement ISO 22000 /FSMS at 3P manufacturing facility and sustain. Drive Good Manufacturing Practices (GMPs) at all Plants. Driving FSSC and developing systems to meet export country requirements (FDA) in 3P units based on business requirements. Conducting process capability study and other process improvement activities using TQM tools. Innovation and Learning Lead and inspire the team of plant quality team by identifying the gaps and define the strategy for capability interventions at the plant level. Implement KAIZEN and continuous process improvements at the units. Develop specialized training initiatives and offer resources that improve employees abilities in continuous improvement practices, data analysis, and creative problem-solving methods.

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOP s , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COA s as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA / Production / PPIC / Warehouse / TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Bachelors degree

Glowria Lifecare Pvt. Ltd. is looking for QA Officer to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control processes and procedures.Conduct audits of production processes and facilities to ensure compliance with regulations and quality standards.Develop and maintain documentation related to quality control activities.Investigate and resolve quality issues, working closely with production, engineering, and other departments.Develop and maintain product or service specifications, quality plans, and procedures.Monitor and analyze quality data to identify trends and opportunities for improvement.Train employees on quality control processes and procedures.Collaborate with suppliers and customers to ensure quality requirements are met.Manage and report on quality control metrics.Ensure compliance with all regulatory requirements and standards.Knowledge of quality control principles, practices, and procedures.Strong analytical and problem-solving skills.Excellent communication and interpersonal skills.

Use Your Power for Purpose Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, your contributions are crucial to ensuring customers and patients receive the medicines they need when they need them. By collaborating with our forward-thinking team, you will help deliver medicines to the world more swiftly by envisioning new possibilities and taking decisive action. What You Will Achieve In this role, you will: Maintenance of PLCs, DCS, SCADA and various Electronic field instruments and sensors Operation and maintenance of pharmaceutical equipment Building Management Systems and Environmental Management system Troubleshooting of automation related issues Awareness of vendor base for automated systems Good Automated Manufacturing Practice guidelines for validation of automated systems Basic HSE and GMP/QA knowledge Knowledge on Clean room requirements, behavior, Good documentation work and Regulatory Guidelines Should able to handle controls, instrumentation, operator interface, vision systems and batch manufacturing system. Provide onsite support in start-up and commissioning of new equipment or upgrades to existing equipment on aspects related to Instrumentation. Trend the breakdowns /concerns of the equipment and implement corrective actions to improve the reliability of the equipment. Here Is What You Need (Minimum Requirements) Bachelors degree in Instrumentation / Electrical / Electronics / Computers with 2-4 years of experience or diploma with 4-6 years of relevant experience, Excellent oral and written communication skills Strong interpersonal skills Teamwork and problem-solving abilities Strong analytical and organizational skills Capacity to quickly identify problems and structure effective solutions Proficiency in Microsoft Office Suite Bonus Points If You Have (Preferred Requirements) Ability to manage multiple tasks simultaneously Experience in a pharmaceutical or manufacturing environment Work Location Assignment: On Premise Engineering #LI-PFE

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Software Quality & Validation Lead What you will do Let s do this. Let s change the world. In this vital role you will be a skilled Software quality & Validation lead to oversee and handle validation activities for data platforms and custom-built 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 align 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. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. You will play a key validation role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, content management, and integrated data to automate the creation, and management of regulatory content. 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. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various layers including data pipelines, APIs, and semantic layers. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Supervise 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. Find opportunities for process improvements in validation activities. Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree with 4-6 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree with 6 - 8 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Must-Have Skills: 5+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). 8-10 Years overall experience in Testing & Validation Projects 3 to 5 years overall experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience implementing and analyzing automated test suites 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) 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 handle 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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. .

To perform Machine and area clearance during dispensing, manufacturing and packaging operation. To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids. To carry out in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol,BMR, BPR, SOPs and other GxP documents. To ensure GMP practices at manufacturing shop floor. To verify raw material dispensing activity. To approve batch coding details during packaging operation. Review of executed batch records and release for next processing stage. Preparation and review of CPV data trend. To perform impact assessment of breakdown memo. To initiate change control, unplanned and planned deviation where ever required. To review area, equipment and cleaning log and to ensure proper labelling. To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records. To perform calibration of IPQA instruments. To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials. To review and approve packaging artworks, proofs and shade cards. To archive executed documents like BMR, BPR, Hold time Protocol etc. To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging. To monitor and record the environmental condition of label control room. To prepare and revise functional SOPs, wherever required. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOP s , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COA s as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA / Production / PPIC / Warehouse / TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Bachelors degree

MetLife is looking for Software Dev Engineer Test II to join our dynamic team and embark on a rewarding career journey. Analyzing customer needs to determine appropriate solutions for complex technical issues Creating technical diagrams, flowcharts, formulas, and other written documentation to support projects Providing guidance to junior engineers on projects within their areas of expertise Conducting research on new technologies and products in order to recommend improvements to current processes Developing designs for new products or systems based on customer specifications Researching existing technologies to determine how they could be applied in new ways to solve problems Reviewing existing products or concepts to ensure compliance with industry standards, regulations, and company policies Preparing proposals for new projects, identifying potential problems, and proposing solutions Estimating costs and scheduling requirements for projects and evaluating results

Sl. No. Responsibilities To follow-up the instructions of Assistant Manager/Dy. Manager- Production and carry out shift production activities as per the plan. Maintains the Logbook as per shift activities. Ensures all the raw materials are available on time for the batches planned and all the required batch sheets are made available. Shall be responsible for making entries in all batch records and other Production related documents and ensure that the recordings are done as and when the operations are completed. Coordinates with Engineering department for the completion of maintenance jobs on time and coordinates with QC on in-process and finished product analysis. Shall follow the GMP and Safety norms in the plant Shall follow the relevant Standard Operating Procedure at various stage of operation. Attending EHS training Program. Shall co-ordinate Production Assistant in maintaining stipulated parameters (like temperature, pH, pressure etc.) during the batch processing. Shall record any abnormality or deviations observed during the processing. Shall maintain Good House Keeping in plant and cleanliness of the equipment. Preparing the instructions (BPCR, BCLR, SOP Check lists etc.) for production of intermediates or APIs according to written procedures. Producing APIs new and, when appropriate, intermediates according to pre-approved instructions. To ensure that production facilities are clean and when appropriate disinfected. To ensure that the necessary calibrations are performed and records kept. To ensure that the premises and equipment are maintained and records kept. To verify the environmental conditions of the controlled area. To have performance control over the contract workmen. To verify the contract worker s health, hygiene conditions for working in controlled areas. To allocate the task to the casuals and have performance control. Responsible to handle tasks other than above assigned by reporting persons time to time.