377 Osd Jobs - Page 3

Roles and Responsibilities Conduct In-Process Quality Assurance (IPQA) activities to ensure compliance with regulatory requirements and company standards. Monitor and control production processes to identify deviations, implement corrective actions, and maintain product quality. Collaborate with cross-functional teams to resolve issues related to formulation, processing, packaging, labeling, and release of products. Develop and maintain documentation for IPQA procedures, protocols, reports, and records. Ensure timely completion of tasks assigned by supervisors or managers within specified deadlines.

Role & responsibilities Sampling and Analysis of water, Raw materials, Packing materials. Sampling of swab samples. Analysis of In process, Finished product, Swab and Stability samples. Responsible for calibration of Balance, conductivity meter and pH meter. Responsible for preparation and pasting of approved labels. Responsible for In process and Finished product sample receipt and analysis. Responsible to perform the analysis by UV-Visible spectrophotometer, KF Autotitrator, Polari meter, HPLC, GC, FTIR, Dissolution, Disintegration, Friability and Hardness tester, Tap density, Melting point apparatus. Responsible for the preparation of Specifications, STP, Analytical Raw data sheets for Raw Materials, Packaging Materials. To ensure that the proper maintenance of department, premises and equipment. Preferred candidate profile B. Pharm / M. Sc in Chemistry or Organic Chemistry or General Chemistry or Pharmaceutical Chemistry or Industrial Chemistry Experience: 2 to 5 years

To perform IPQA activities at shop floor in every stage of OSD manufacturing and packing. Review of BMR & BPR. Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. Review of documents of respective areas and logbooks for adequacy and completeness. QA overview for receipt of material from warehouse to production. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. Preparation & Review of process validation protocols and reports. Any job activity assigned by HOD

Role & responsibilities : 1) Having from OSD background. 2) Responsible for analysis of RM/IP/FG/Stability on HPLC. 3) Responsible for Calibration of HPLC 4)Having the Knowledge of the Pharmacopeia.IP/BP/Ph.Eur/USP Skill Required: 1) Handling of the HPLC, 2) Calibration Management. 3)Knowledge of the GLP Environment 4) Handling of the HPLC, 5) Calibration Management. 6)Working Standard, Ref. Standard, Imp Standard, Primary Standard Management Additional Remark: Required candidates background should be in Regulatory environments

We re in an unbelievably exciting area of tech and are fundamentally reshaping the data storage industry. Here, you lead with innovative thinking, grow along with us, and join the smartest team in the industry. This type of work work that changes the world is what the tech industry was founded on. So, if youre ready to seize the endless opportunities and leave your mark, come join us. SHOULD YOU ACCEPT THIS CHALLENGE Pure Storage India is seeking an experienced Systems Engineer to join the Sales team in Mumbai . In this role, you will leverage your technical expertise to pilot the sales & adoption of our PURE solutions with prospects and existing customers in the Enterprise Accounts space. You collaborate with customers to understand their business goals, their pain points, and propose creative solutions in collaboration with our key alliance partners. You will work closely with other pre-sales, sales, partner sales & enablement, marketing, and leadership team members to help develop and grow business with the full PURE portfolio of solutions. In this role you will: Demonstrate thought- and practice-leadership as a member of our SE team Participate in the creation of sales strategy and tactics and takes ownership of technical responsibilities within Indias Commercial accounts Assist customers with evaluations and benchmarks, system configurations, and system installations Work closely with Engineering and Product Management in helping to define product requirements and usability Demonstrate technical leadership and subject matter expertise on storage products, distributed storage architectures, file systems, and competitive storage offerings in the DAS, NAS and SAN product spaces Mentor other team members to continually advance their technical and customer acumen WHAT YOU LL NEED TO BRING TO THIS ROLE... 10+ years minimum experience supporting the sales of Indias enterprise storage, networking or systems solutions to a combination of large enterprise accounts and data centers Thorough understanding of the architecture, design and implementations of multi-tiered client/server and web-based computing solutions Preparation and delivery of technical product and architecture presentation Contribute significant portions and/or lead responses to RFPs, RFQs and RFIs Superior knowledge of current and emerging storage architectures (FC, iSCSI, NAS, OSD, SAN) Familiarity with modern web architecture a plus (LAMP stack, scale-out vs scale-up architectures, NoSQL alternatives) UNIX OS, NFS file systems, and UNIX distributed network environment Installation/configuration of distributed computing, multiprocessing, virtual memory subsystem, storage subsystems architecture, shared memory architectures, cache architectures, windowing systems Knowledge of VMWare, Local Area Networking, Ethernet, TCP/IP and general networking Excellent verbal and written communication skills BS in CS, EE or other technical degree and/or equivalent experience. And because we understand the value of bringing your full and best self to work, we offer a variety of perks to manage a healthy balance, including flexible time off, wellness resources, and company-sponsored team events - check out purebenefits.com for more information. WHAT YOU CAN EXPECT FROM US: Pure Innovation : We celebrate those who think critically, like a challenge and aspire to be trailblazers. Pure Growth : We give you the space and support to grow along with us and to contribute to something meaningful. We have been Named Fortunes Best Large Workplaces in the Bay Area , Fortunes Best Workplaces for Millennials and certified as a Great Place to Work ! Pure Team : We build each other up and set aside ego for the greater good. And because we understand the value of bringing your full and best self to work, we offer a variety of perks to manage a healthy balance, including flexible time off, wellness resources and company-sponsored team events. Check out purebenefits.com for more information. ACCOMMODATIONS AND ACCESSIBILITY: Candidates with disabilities may request accommodations for all aspects of our hiring process. For WHERE DIFFERENCES FUEL INNOVATION: We re forging a future where everyone finds their rightful place and where every voice matters. Where uniqueness isn t just accepted but embraced. That s why we are committed to fostering the growth and development of every person, cultivating a sense of community through our Employee Resource Groups and advocating for inclusive leadership. At Pure Storage, diversity, equity, inclusion and sustainability are part of our DNA because we believe our people will shape the next chapter of our success story. Pure Storage is proud to be an equal opportunity employer. We strongly encourage applications from Indigenous Peoples, racialized people, people with disabilities, people from gender and sexually diverse communities, and people with intersectional identities. We also encourage you to apply even if you feel you don t match all of the role criteria. If you think you can do the job and feel you re a good match, please apply.

Experience : Minimum 7-10 years of hands-on experience in formulation and technological process development of various solid oral dosage forms for regulated markets such as the US, EU, and Canada. Formulation Strategy & Execution : Expertise in designing formulation and process development strategies, planning and executing activities to develop robust, scalable products within defined timelines. This includes literature reviews, pre-formulation studies, laboratory trials, and detailed documentation in electronic lab notebooks (eLNs). Product & Process Optimization : Skilled in formulation and process optimization, execution of pilot bioequivalence (BE) batches, and application of Quality by Design (QbD) principles. Familiar with bio study requirements and timelines for sample submissions. Cross-functional Coordination : Strong coordination with departments such as Analytical, Regulatory Affairs, Production, QC, Procurement, and other cross-functional teams to ensure efficient product development and execution. Involved in drafting and reviewing in-process and finished product specifications. Documentation & Compliance : Responsible for preparing protocols, technology transfer documents, stability and interim reports, and comprehensive product development reports with a focus on accuracy, compliance, and regulatory requirements (Module 3). Technology Transfer : Proficient in executing technology transfer to manufacturing sites by applying scale-up principles and supporting smooth execution at commercial scale. Regulatory Support : Experience in supervising and addressing regulatory queries is an added advantage. Additional Responsibilities : Willing to undertake additional tasks as assigned to support project success. Project Alignment : Works closely with cross-functional teams (CFTs) and aligns effectively with Project Management to meet project goals. Must have experience in working in oncology ( anti cancer ) OSD formulation.

Walk In Drive For Engineering Services Department Formulation's Division @ Burgul Interview Date : 19-07-2025 Department : Engineering Services OSD, Formulations Qualification : Diploma | B Tech ( Mechanical | Electrical | Instrumentation ) Work Location : MSN Formulations Unit-VI, Burgul Interview Venue Details :- X59Q+P95, Mothighanapur, Burgul, Telangana 509202

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Document and Reporting Compliance Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. You will be responsible for overseeing the application development process and ensuring successful project delivery. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work-related problems.- Lead the design, development, and implementation of SAP Document and Reporting Compliance applications.- Collaborate with cross-functional teams to gather requirements and ensure project alignment.- Provide technical guidance and mentorship to junior team members.- Ensure compliance with industry standards and best practices in application development.- Conduct regular code reviews and performance evaluations to maintain high-quality standards. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP Document and Reporting Compliance.- Strong understanding of SAP data structures and reporting functionalities.- Experience in SAP security and authorization concepts.- Knowledge of SAP BusinessObjects reporting tools.- Hands-on experience in SAP data extraction and transformation processes. Additional Information:- The candidate should have a minimum of 3 years of experience in SAP Document and Reporting Compliance.- This position is based at our Pune office.- A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Document and Reporting Compliance Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Showcasing your leadership skills, you will drive the team towards successful project completion and client satisfaction. Roles & Responsibilities:- Expected to be an SME- Collaborate and manage the team to perform- Responsible for team decisions- Engage with multiple teams and contribute on key decisions- Provide solutions to problems for their immediate team and across multiple teams- Lead the team in project planning and execution- Ensure adherence to project timelines and quality standards- Facilitate communication between team members and stakeholders Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP Document and Reporting Compliance- Strong understanding of compliance regulations and reporting standards- Experience in designing and implementing compliance solutions- Knowledge of SAP systems and reporting tools- Ability to analyze and interpret complex data- Excellent communication and leadership skills Additional Information:- The candidate should have a minimum of 5 years of experience in SAP Document and Reporting Compliance- This position is based at our Pune office- A 15 years full-time education is required Qualification 15 years full time education

In-Process as per BMR. Monitoring of environmental condition in cubicles under operation. line clearance without any observation . Identifying and resolving production-related issues, implementing corrective and preventive actions (CAPA), and conducting root cause analysis. Maintaining accurate and up-to-date manufacturing documentation, including batch records, logbooks, and SOPs. Maintaining a strong understanding and adherence to Current Good Manufacturing Practices (cGMP) within the production facility. Maintaining a strong understanding and adherence to Current Good Manufacturing Practices (cGMP) within the production facility. Preferred candidate profile Preferred Candidate from pharma formulation background only .

Role & responsibilities Excellent communication skills both written and verbal. High level of understanding and proven management of SCCM hierarchy Experience with MDM Platform Intune/Co-management. Knowledge of Windows operating system, patching, enterprise class desktop hardware and software such as Windows 10, Mobile Device OS, and antivirus. Remote management and troubleshooting. Advance knowledge and technical ability of WSUS within SCCM/MECM. Patching concepts, best practices and troubleshooting skills. Strong analytical, troubleshooting, and problem-solving skills. Able to work effectively under deadlines in a fast-paced, changing environment. Ability to organize and manage multiple requests with frequently conflicting priorities. Strong team player - collaborates well with others to solve problems and actively incorporates input from various sources. Should have understanding of multi-tiered SLA management, Incident Management, Change Management, and Problem Management. Added Advantage if candidate possess below Microsoft certificates: Installing and Configuring Windows Server 2012; Exam 70-410 (MCSE) Administering Windows Server 2012; Exam 70-411 (MCSA) Administering Microsoft System Center Configuration Manager and Cloud Services Integration; Exam 70-703 Microsoft SCCM Intune Certification; Exam 70-696 ITIL v4 Preferred candidate profile Responsible for managing and maintaining the SCCM/MECM hierarchy. Troubleshoot issues related to different SCCM/MECM components like, Management Point, Distribution Point, Reporting Services, Software Update Point, WSUS, Cloud Management Gateway, IBCM etc. Create Applications and Packages and deployment via SCCM and troubleshoot issues related to Application deployment, package deployment etc. Manage Endpoints and Servers using SCCM and troubleshoot Client related issues to ensure SCCM/MECM client health. Ensuring Servers and Endpoints are patched on monthly basis via SCCM/MECM with their standards. Should also be able to troubleshoot Software Update Point/WSUS and Client specific patching issues. Should have hands on experience with generating monthly reports through SSRS, create patching dashboard, client health dashboards and any other custom reports based on customer requirements. Should have basic understanding on concepts of Operating System Deployment. Should possess a fair technical understanding of task sequences and troubleshooting. Responsible for performing regular Intune/Co-Management related tasks like, Add Users, User Groups, Assign Intune licenses to Users, Device Enrollment etc. Responsible for managing MDM and MAM policies, customize company portal, assign apps to groups or users, configure app protection policies etc. Management of Incidents and Work Requests in ITSM tools like Service Now, BMC Remedy etc, ensuring SLA's and KPI's are achieved. Work closely with team members and collaborate with others to facilitate and achieve Team objectives or goals. #LI-KR2

Validation Master Plan (VMP, PVMP, CVMP, QMP) Qualification and Validation Documents and execution BMR, BPR, log book, Protocol, Report and SOP Required Candidate profile Preparation and review of PPQ and cleaning validation protocol monitoring of PPQ and cleaning validation activities To prepare and review (SOP's) and procedures related to validation

Job Summary: Walter Bushnell is seeking a Research Scientist - Formulations with experience in Solid Oral Products to join our R&D team . The candidate will be responsible for formulation development, process optimization, and ensuring regulatory compliance for solid dosage forms. Key Responsibilities: Develop and optimize formulations for solid oral dosage forms (tablets, capsules, granules, etc.). Conduct pre-formulation studies, excipient compatibility tests, and stability studies . Perform process development, scale-up, and technology transfer for new formulations. Prepare and maintain technical documentation, protocols, and reports as per regulatory guidelines. Ensure compliance with cGMP, ICH, and regulatory standards for formulation development. Collaborate with analytical, regulatory, and manufacturing teams for successful product development. Troubleshoot formulation and process-related challenges to improve product stability and quality. Qualifications & Skills: Education: M. Pharm / B. Pharm in Pharmaceutics or related field. Experience: 4-5 years in formulation development of solid oral products . Strong knowledge of cGMP, ICH guidelines, and regulatory requirements . Hands-on experience in process optimization, scale-up, and tech transfer . Proficiency in documentation and regulatory compliance . How to Apply: Interested candidates can share their resumes at akanksha.jaiswal@walterbushnell.com . For further details, you can directly reach out at 7042636289 .

Role & responsibilities 1 As a Plant GM production Candidate will be responsible for handling entire plant operation including Production Packaging, Engineering, Warehouse store and also HR Commercial & Admin, Audit and Employee Relation. 2. Candidate will be responsible for handling Production activities of OSD, Liquid Packaging, including Manufacturing, filling, packing etc. 3. You will be also responsible for handling WHO GMP audit and all Regulatory compliances including Dealing with FDA and other authorities. 4. Candidate will be responsible for handling 300 plus employees working at Nashik plant including contract Labour. 5. Candidate will be responsible for handling dealing with Government Authorities & Local union. Preferred candidate profile Candidate should be B.Pharma / M. Pharma / with 20 to 25 Years of Experience in Handling Production of Pharma formulation OSD, Liquid for domestic & ROW Market. 1. Candidate will be handling Entire Manufacturing Operation including Production, Packaging, engineering, HR commercial & Admin, Audit and employee Relation. 2. Candidate must have depth knowledge of OSD, Liquid manufacturing processes, GMP, Regulatory Requirements, and quality systems. 3. Candidate should have well in handling Automation and Operational Excellence. 4. You should be good in handling and dealing with various government Authorities and inspection /Audits 5. Candidate having experience working on ERP systems (e.g., SAP) used in pharmaceutical Manufacturing.

Project Role : Infra Tech Support Practitioner Project Role Description : Provide ongoing technical support and maintenance of production and development systems and software products (both remote and onsite) and for configured services running on various platforms (operating within a defined operating model and processes). Provide hardware/software support and implement technology at the operating system-level across all server and network areas, and for particular software solutions/vendors/brands. Work includes L1 and L2/ basic and intermediate level troubleshooting. Must have skills : Microsoft Endpoint Configuration Manager Good to have skills : Microsoft Active DirectoryMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time educationRole:Image Management & OSD Customization SpecialistRole Description:a talented and experienced technical expert to join our team as a Image Management lead. In this role, you will be responsible for automating the creation and maintenance, and lifecycle management of machine images across multiple environments using System Center Configuration Manager, OSD Customization, Microsoft Deployment Toolkit etc. and will be knowing about SCCM infrastructure & Configuration in depth and provisioners to ensure our images are consistent, reliable, and meet our specific requirements. Must Have Skills: Microsoft System Center Configuration Manager, Microsoft Deployment Toolkit, OSD Customization, PowerShell, WIM (Windows Imaging Format) and ImageX . Autopilot & Intune etc.Key Responsibilities:He will collaborate closely with platform engineers, cloud architects, security teams, and application owners to ensure secure, scalable, and standardized Golden images are delivered for hybrid and cloud-native systems.Key Responsibilities and Skills: Creating and maintaining OS images:This involves capturing a baseline OS image (often referred to as a "Golden image") and then customizing it with specific applications, drivers, and settings. Frequent hardening of the OS images and maintain it under registry/galleryIntegrate security best practices, including vulnerability scanning, patching, and hardening as part of the image build lifecycle.Ensure standardized, reproducible, and version-controlled image deployment for both on-premises virtual machines and cloud-based instances (AWS, Azure Images, GCP Images, etc.).Automating Image Creation:Define templates to automate the creation of machine images for various Windows OS platforms through SCCM, MDT etc.Image Customization & Deployment:Deploying the customized image to target computers, either remotely or locally, using tools like SCCM, MDT or Offline Media.Understanding Windows OS Imaging:Knowledge of Windows imaging technologies like WIM (Windows Imaging Format) and ImageX is crucial. Troubleshooting:Ability to troubleshoot issues related to OS image deployment and configuration. Hardware integration:Understanding to integrate different hardware models with the OS image, manage drivers & Hardware certification etc. Security:Hardening and implementing security best practices for OS images and deployment. Establish monitoring and reporting for image lifecycle management and audit readiness.Partner with infrastructure, application, and security teams to troubleshoot image-related deployment and performance issues. Technical Experience:Minimum 5+ years of operational experience, Azure cloud certification required.Scripting and Automation:Experience with scripting languages (e.g., PowerShell, BAT file and automation tools.Must have knowledge in Autopilot & Intune Operating Systems:Knowledge of all platforms of Windows operating systems. Expert hands-on experience on maintaining image templates.Problem-solving and Communication:Ability to troubleshoot issues, communicate effectively, and collaborate with other team members. Professional Attributes:Strong written and verbal communication skills, interpersonal skills.Strong time management skills, problem solving and analytical skills.Ability to work and collaborate remotely.Primary work schedule is aligned with US Eastern business hours.Due to the 24X7 operations of the business, must be able to work a flexible work schedule, may include nights, weekends, and holidays. Qualification 15 years full time education

Interview on 26 July, Saturday for BSC Chemistry Fresher for Production Department for Large Formulation Pharma Company in Ankleshwar Call / WhatsApp on 9727755967 for More Details Send CV on sdpbharuch@gmail.com with Subject: Production Ankleshwar Required Candidate profile Join My LinkedIN: https://www.linkedin.com/in/urvisdp INTERVIEW VENUE: SDP HR SOLUTION, 610, GOLDEN SQUARE, OPPOSITE HOTEL REGENTA, NEAR ABC CIRCLE, BHOLAV, BHARUCH We Provide Best Jobs in Gujarat

Interview on 26 July, Saturday for BSC Chemistry Fresher for Production Department for Large Formulation Pharma Company in Ankleshwar Call / WhatsApp on 9727755967 for More Details Send CV on sdpbharuch@gmail.com with Subject: Production Ankleshwar Required Candidate profile Join My LinkedIN: https://www.linkedin.com/in/urvisdp INTERVIEW VENUE: SDP HR SOLUTION, 610, GOLDEN SQUARE, OPPOSITE HOTEL REGENTA, NEAR ABC CIRCLE, BHOLAV, BHARUCH We Provide Best Jobs in Gujarat

Role & responsibilities Need a ITI fitter Candidate for handling plant preventive maintenance of OSD machines(Granulation, compression, coating and packing) Experience must be there in the following machines:- RMG, FBD, MultiMill, cadmac, fette, sejong, ctx, Pharma Pack, CVC

Job Requirements: 1. Operators & Officers for OSD Production & Packing (Onco & Non-Onco) Experience: 0 to 6 Years Qualifications: I.T.I / Diploma / D. Pharmacy / B. Pharmacy Key Responsibilities: Operate equipment such as Granulation, Compression, Coating, Capsule Filling, Blister Packing, and Bottle Packing. Supervise production lines including Granulation, Compression, Coating, and Packing (Blister/Bottle). Good verbal and written English communication skills 2. Training Coordinator for OSD & Sterile Production & Packing Experience: Minimum 3 to 5 Years Qualification: B. Pharmacy Key Responsibilities: Conduct SOP training sessions for staff employees, casuals, and workmen. Ensure effective delivery of training on the shop floor. Maintain training records. Good verbal and written communication skills. Date: Saturday, 19th July 2025 Time: 9:00 AM to 2:00 PM Venue: Natco House, Road No. 2, Banjara Hills, Hyderabad 500034 (Opposite A.P. Productivity Council) Important Notes: Only candidates with formulation experience and regulatory exposure will be considered. Candidates interested in working at the Kothur location are requested to attend the interview. Encourage only male candidates due to rotational shifts, as it is in production areas.

Exp: 4+ Years Education: Any Degree Work Location: Bangalore (Marathahalli 5 days WFO) JD : SCCM Administration Security Baseline Monitoring SCCM Client Install Troubleshooting guidelines SCCM Client Settings Asset Intelligence Compliance SCCM Monitoring and Maintenance (DP, MP, SUP etc) Boundary and Boundary group creation Patch Management - For Win clients and Servers Software deployment + App creation using SCCM + Driver package creation Collection Creation WQL Queries (For Collection) OS Deployment Task Sequence creation using SCCM PXE Boot, WinPE, Golden Image creation Driver Injection Feature updates, Windows Servicing Plans, O365 upgrade (ODT) Reporting (PS, SQL) Table creation, CMPivot, List of queries example Debugging skills in terms of patch/deployment issues.

Role & responsibilities Responsible for Pre-formulation studies for lab formulation development trials of solid orals, Oral Liquid, injectable, products, and Nutraceuticals product. To design strategy for projects through literature surveys. Respective API characterization, excipients characterization, drug and excipient study and its ratio. Worked on different manufacturing strategies for the development of products. To evaluate product for stability in manufacturing, monitor and review the stabilized batches. To study on existing formulations. Responsible for co-ordination, execution and monitoring of scale up activity, Responsible for Trial batches, Scale up batches, Optimization batches, Exhibit batches. Co- ordination with all cross-functional teams. TT sites and LL Sites To design/assist/support/ review for documents such as SOP, LNB, QQ, Risk assessment, PDR, MFR, Scale up BMR, stability protocol, qualification, validation documents, change controls, deviations, investigations and CAPAs etc. Preferred candidate profile pharma THANKS YOU REGARDS MILAP RATHOD (7486829377) any time call me or whtup HR DEPARTMENT OPES HEALTHCARE PRIVATE LIMITED

We are a Pharma Mfg located in Dabaspet. We are looking to hire QA Executive for our Tablets mfg and pkg dept. who will be dedicated full time. B.Pharma. Minimum Exp. (3-5 years OSD formulation). Interested send resume to watsapp 9739978848

Role & responsibilities Shall be take care of process Equipments ( preventive Maintenance , Breakdown , QMS ) Preferred candidate profile Candiate should have very deep knowledge about preventive maintenance and breakdown activities pertaining process equipments. Also shold velwersed with QMS GMP activities.

JOB DESCRIPTION Job Title: Lead - Tech support (LIMS/ELN-QCM) Job Location: Bangalore About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role : Static data creator/ reviewer for LIMS Validation of LIMS and ELN sheet Thorough knowledge on LIMS development, validation and GMP modules Knowledge on guidelines requirement for microbial analysis Ensure Microbial Method Validation, Method verifications Planning Microbiology analysis (Bioburden, MLT, Test for specified organisms, BET analysis) Sterility testing and validation Calibrations, Qualifications in Microbiology lab Handling QMS in Microbiology lab Role Accountabilities Documents preparation/review/validation for LIMS and ELN for microbiology Facing regulatory and client audits, ensuring audit compliance Leading team for Microbial analysis section Ensuring Microbiology lab maintenance Media and culture qualifications data review and planning Responsible for Ensuring Microbiological analysis, Sterility testing, Bacterial Endotoxin Test and analysis of different grades of water (PW/WFI/POW) as per the respective specification. Responsible for risk assessment documents preparations, Protocol and reports preparation Responsible for QMS related to microbiology - change controls, CAPA, deviations, incidents, OOS/OOT investigations Responsible for Area qualification, calibrations, equipment qualifications and requalification Responsible for sample management and coordination with team for smooth operation of samples release activity. Responsible to perform the Method verification activity for Sterility, BET, MLT and Bioburden test. Responsible for review of microbiology documents Responsible for review of specifications and STP. Responsible for review of protocols and reports Preparation and planning of sampling schedule Interaction with clients Ready to work in shifts and supervising the shift analyst activities Follow the required EHSS policies and Good hygiene practice. Undertake other responsibilities related to Microbiology as per requirement. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role Experience : Demonstrated Capability : Education : Experience : 9-10 yrs YEARS Skills and Capabilities Microbial analysis of water, OSD products, Injectable products, Environmental monitoring Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team Good speaking-listening-writing skills, attention to details, proactive self-starter Ability to work successfully in a dynamic, ambiguous environment Ability to meet tight deadlines and prioritize workloads Ability to develop new ideas and creative solutions Should be able to work in team and flexible for working in shifts Should be a focused employee Good documentation capability Education : M. Sc. Microbiology Equal Opportunity Employer .

JOB DESCRIPTION Job Title: QC Microbiology Reviewer Job Location: Bangalore About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role : Static data creator/ reviewer for LIMS Facing regulatory and client audits, ensuring audit compliance Microbial Method Validation, Method verifications Microbiology analysis (Bioburden, MLT, Test for specified organisms, BET analysis) Sterility testing and validation Environmental/Utility Monitoring data review Microbiology lab maintenance Calibrations, Qualifications Review of Microbiology data Media and culture qualifications data review and planning Handling QMS in Microbiology lab Role Accountabilities Responsible for Microbiological analysis, Sterility testing, Bacterial Endotoxin Test and analysis of different grades of water (PW/WFI/POW) as per the respective specification. Responsible for risk assessment documents preparations, Protocol and reports preparation Responsible for QMS related to microbiology - change controls, CAPA, deviations, incidents, OOS/OOT investigations Responsible for Area qualification, calibrations, equipment qualifications and requalification Responsible for sample management and coordination with team for smooth operation of samples release activity. Responsible to perform the Bioburden and Microbial Limit Test. Responsible to perform the Method verification activity for Sterility, BET, MLT and Bioburden test. Responsible for ensuring environmental monitoring of clean rooms in Microbiology laboratory. Responsible for review of microbiology documents Responsible for preparation of specifications and STP. Responsible for preparation of protocols and reports Audit trail review Preparation and planning of sampling schedule Interaction with clients Ready to work in shifts and supervising the shift analyst activities Well versed with LIMS and electronic documents execution and review. Follow the required EHSS policies and Good hygiene practice. Undertake other responsibilities related to Microbiology as per requirement. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader (only for Leadership Hires) Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role Experience : Demonstrated Capability : Education : Experience : 9-10 yrs YEARS Skills and Capabilities Microbial analysis of water, OSD products, Injectable products, Environmental monitoring Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team Good speaking-listening-writing skills, attention to details, proactive self-starter Ability to work successfully in a dynamic, ambiguous environment Ability to meet tight deadlines and prioritize workloads Ability to develop new ideas and creative solutions Should be able to work in team and flexible for working in shifts Should be a focused employee Good documentation capability Education : M. Sc. Microbiology Equal Opportunity Employer .