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0.0 years
0 Lacs
ahmedabad, gujarat, india
On-site
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. This position provides support to the Analytical development laboratory in technical and operational activities such as hands-on support for Physico-chemical analysis, Instrumental analysis , and material characterization or testing for product development. The successful candidate will need to possess solid hands-on technical abilities, excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. The incumbent will perform other duties as assigned. . Define, organize, plan and execute analytical activities and materials characterization of pharmaceutical injectables in compliance with current international/regional/national regulations with the support of senior colleagues and team member s. . Execute experiments towards method development, failure analysis , and root cause analysis in new product development and sustaining product projects within specified timelines, under supervision. . Work with and interpret data of advanced instrumentation techniques, hyphenated techniques , and other analytical techniques. . Execution of work as per standard guidelines like cGLP, GDP, cGMP, Data Integrity, ALCOA, and as per Baxter's defined systems, whenever applicable. . Investigate and provide technical insights for observed adverse physicochemical issues during product devel opment, scale-up, or post-marketing phases. Engage in science-based troubleshooting of the issues. . Provide proposals for product development-related innovations, analytical method innovations, and product/process improvement initiatives in collaboration with senior scientists . Ensure good internal and cross-functional communication and regular status update of activities. . Preparation of scientific product development reports, proposals, and presentations . Work collaboratively with the multi-functional and international project team in activities such as sample preparation for analysis, and operation of analytical instruments as per project requirements. . Provide support as needed in calibration and maintenance of equipment in the laboratory. . Follow Baxter's Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day -to-day activities, to ensure proactive compliance and continuous improvement Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
hyderabad, telangana
On-site
As a Product Owner for ELN platforms such as Benchling, iLab, and Biovia, you will be responsible for defining and managing the product vision, roadmap, and backlog for ELN solutions in the Pharma or Life Sciences industry. Your role will involve gathering and prioritizing requirements from R&D, lab users, and business stakeholders to ensure the successful development and integration of ELN systems. Collaboration with technical teams will be a key aspect of your responsibilities, as you will work closely to drive ELN development, customization, and integration. It will be essential to ensure seamless interoperability of ELN with other lab systems such as LIMS, CDS, and SDMS. Moreover, you will play a crucial role in aligning ELN solutions with regulatory standards like GxP, ALCOA+, and industry best practices. Your efforts will contribute to facilitating user adoption through training, documentation, and stakeholder engagement, thereby ensuring the efficient utilization of ELN platforms within the organization.,
Posted 2 weeks ago
2.0 - 6.0 years
0 Lacs
indore, madhya pradesh
On-site
You will be responsible for Vial washing, Depyrogenation tunnel, and filling with isolator activity for startup and routine operation. It is important to ensure adherence to cGMP and ALCOA in your daily activities and comply with organizational policies and procedures. In this role, you will be responsible for the preparation and implementation of procedures related to qualification and maintenance activities for the Injectable facility. Reviewing, implementing, and maintaining cGMP standards in all work areas will be a key part of your responsibilities. Additionally, you will be involved in the preparation, review, approval, and implementation of Standard Operating Procedures while following guidelines. Your role will also include meeting monthly productivity targets and ensuring dispatches are made as per the schedule.,
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
As an Analytical Chemist at our company, you will be responsible for developing analytical methods using techniques such as HPLC, GC, LCMS, KF, and FTIR for routine analysis. You will also be in charge of maintaining analytical documentation including protocols, specifications, etc. Calibration of HPLC and GC instruments will be part of your regular tasks. It is essential that you are knowledgeable about data integrity and ALCOA guidelines. Additionally, you will be involved in chiral method development to support our analytical processes.,
Posted 1 month ago
0.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Analytical method development Routine Analysis by HPLC, GC, LCMS, KF and FTIR Analytical documentation as like Protocols, specifications etc. Calibration of HPLC, GC instruments Aware about data integrity and ALCOA Chiral method development Show more Show less
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
Job Description: As an Executive or Senior Executive at Syngene, you will be responsible for method development, validation, and stability testing of drug substance/drug product. Your primary role will involve having strong hands-on experience in developing and validating Assay & related substances methods for drug substance/drug product. Additionally, you will be expected to work with complex injectables and be willing to work in shifts. Your core responsibilities will include handling instruments such as HPLC, UPLC, GC, UV Visible spectrophotometer, balances, Potentiometer, and stability chambers. You must be well-versed in Good documentation/laboratory practices like ALCOA+ and have experience in calibration and qualification of laboratory instruments. Furthermore, you will be accountable for preparing and reviewing raw data sheets, instrument operating procedures, and standard operating procedures. In this role, you will also be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares required for projects. Adherence to GxP/Safety procedures and internal standard operation procedures is crucial. Proficiency in operating MS Office tools and effective communication skills are essential for interactions with clients and external users. To excel in this position, you should possess good interpersonal skills, self-time management abilities, and be a strong team player. The role also requires polite and effective communication skills. Syngene Values: At Syngene, we uphold the values of Excellence, Integrity, and Professionalism, and as a team member, you are expected to consistently demonstrate alignment with these core values. Specific Requirements: - Experience: 3-6 years - Skills And Capabilities: Hands-on experience in HPLC, UPLC/UHPLC, GC, UV-Visible spectrophotometer, Potentiometer, and other analytical instruments. Knowledge of good documentation/laboratory practices such as ALCOA+ is required. Experience in particle size determination, Zeta potential, and particulate matter analysis techniques will be advantageous. Familiarity with SEC, CGE methods for mAbs is a plus. Proficiency in MS Office tools is necessary. - Education: M. Pharm /M. Sc with 3-6 years" experience in R&D under GMP environment (QC) If you meet the requirements mentioned above and are looking to contribute to a culture of safety, innovation, and excellence, we invite you to apply for this exciting opportunity at Syngene.,
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
indore, madhya pradesh
On-site
We are looking for a Computer System Validation (CSV) Engineer with specialization in SAP HANA/S/4HANA validation to join a prestigious MNC Pharma company at their corporate headquarters in Mumbai. As a CSV Engineer, your main responsibilities will include developing and overseeing CSV deliverables such as VP, URS, FRA, IQ/OQ/PQ, etc. It is essential to ensure adherence to regulatory standards like 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborating with diverse teams including QA, IT, and BPOs will be a key aspect of your role. Additionally, managing SAP system upgrades, patches, and audits will be part of your day-to-day tasks. The ideal candidate should hold a Bachelor's degree in Computer Science, Engineering, or Life Sciences and possess a minimum of 3 years of experience in CSV within regulated industries. Proficiency in GxP, ALCOA+, and data integrity standards is required. Candidates with SAP HANA Certification and experience in audit trails, security roles, EDMS/QMS are preferred for this role. This is a full-time position located in Mumbai. To apply, please send your CV to ankur.tiwari@ics-india.co.in or contact +91 9109188512. Join us now and contribute to the global pharmaceutical innovation journey.,
Posted 1 month ago
4.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,
Posted 1 month ago
4.0 - 6.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Role & responsibilities: Issue of Study Documents, SOPs, Work Instructions, Method Procedures, Test Procedures, Forms, Manuals & Logbooks. Archival and Retrieval of study documents & General Documents. Maintenance of Sops work instructions, Forms, Manuals, Bincards, Logbooks and general documents indexes. Maintenance of studies archival list with third party (WIMS). Obsoletion of Sops, work instructions, Forms & general data scanned & Ture copy certification. X-Ray evaluations year wise verified. Screening failures & Validity completed documents are arranged & scanned, verified true copy certification. Agreements, vendors, consultants due dates verification and maintenance of indexes. All department Sops review dates also maintained ii year wise. Maintenance of all employee training records with hard copy and scan copies. Maintenance of study documents, general documents and sent to archival for third party WIMS. Updating indexes of archival racks for identifying study and general documents. Maintenance of all left employee training records with hard copy and scan copies verified and done by true copy certification. Maintenance and archival of Calibrations, Qualification and Method Validations general files along with updated index labels. All other activities assigned by department head as per requirements. Preferred candidate profile: Interested and suitable applicants can mail their updated CV to hr@qpsbioserve.com. Note: We are looking for candidate who are willing to join on immediately.
Posted 2 months ago
2.0 - 6.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Hiring: Operators & Officers for OSD Production & Packing (Onco & Non-Onco) | Sterile Production | Quality Control | Microbiology Interview Location: Elite Hotel, Jadcherla Walk-in / Immediate Joiners Preferred 1. Operators & Officers for OSD Production & Packing (Onco & Non-Onco) Experience: 2 to 6 Years Qualifications: I.T.I / Diploma / D. Pharmacy / B. Pharmacy Job Responsibilities: Operation of equipment: Granulation, Compression, Coating, Capsule Filling, Blister & Bottle Packing Supervision of Granulation, Compression, Coating, and Packing lines (Blister/Bottle) 2. Officers & Operators for Sterile Production (Onco) Experience: 2 to 6 Years Qualifications: Diploma / B. Sc / D. Pharmacy / B. Pharmacy Job Responsibilities: Supervision of Manufacturing, Compounding, Filling, Filtration, and Packing areas Strong knowledge of QMS (minimum 5 years preferred) Hands-on experience in Manufacturing and Compounding Operation of equipment in Filling, Filtration, and Packing 3. Analyst for Quality Control Experience: 2 to 5 Years Qualifications: M.Sc / B. Pharmacy Job Responsibilities: Analytical testing of Finished Products, Stability Samples, and Packaging Materials Proficient in handling instruments HPLC, LIMS, Dissolution Apparatus, UV Spectrometer, KF Apparatus, IR Spectrometer, Metrohm Auto Titrator RM/PM/IP/FP analysis, Assay, and Dissolution using HPLC Strong understanding of GLP, GDP, cGMP, ALCOA & ALCOA+ principles 4. Microbiologist for QC Micro (OSD / Injectables) Experience: 0 to 6 Years Qualification: M. Sc (Microbiology) Job Responsibilities: MLT & BET Analysis, Sterility Testing Water Sampling and Analysis Environmental Monitoring Activities Note: Only Formulation experience with Regulatory exposure will be considered.
Posted 3 months ago
2 - 7 years
2 - 7 Lacs
Ahmedabad, Rajoda, SEZ Matoda,Rajoda
Work from Office
Walk-in Drive @ Ahmedabad on 18th May'25 (Sunday) for Quality Control Department We are looking for suitable candidates for OSD Quality Control for Ahmedabad location Unit Interview Venue Details: Date: 18th May 25 (Sunday), Time: - 9:00 AM to 1:00 PM Venue : Amneal Pharmaceuticals Pvt. Ltd Survey No. 634,637-641 Village: Rajoda Tal: Bavla Dist: Ahmedabad -Gujarat - 382220 1) REQUIREMENT FOR OSD QUALITY CONTROL DEPARTMENT Total Experience: 02 to 7 years (Pharma experience only) Qualification: B.Sc./ M.Sc/ B. Pharm/ M. Pharm Designation: Officer/ Sr. Officer /Executive/ Sr. Executive Department: Quality Control Desired Profile: Test RM, PM, in-process, finished & stability samples (various dosage forms i.e., tablet, Capsules, oral suspension/ ointment/powder etc) as per SOPs/pharmacopeia Operation of HPLC, GC, UV, FTIR, Dissolution, KF, wet & physical tests Troubleshoot basic issues Ensure ALCOA adherence in shift activities Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP and understanding of regulatory requirement will be preferred. Note : Candidate should relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliant) organization. Kindly carry your updated CV along with copies of CTC proof, Appointment letter, Increment letter, last 3 months salary slips, Bank statement, Education certificates & Marksheets, Aadhar & PAN card and passport size photograph, at the interview venue. Disclaimer: Beware of fake job offers claiming to be from Amneal Pharmaceuticals Pvt. Ltd. or Companies under Amneal Group (collectively referred to as AMNEAL). Amneal neither send job offers from free email services like Gmail, Rediffmail, Yahoo mail, Hotmail, etc. nor charges any fees/security deposit from any job seekers. Amneal will not be responsible to anyone acting on an employment offer not directly made by Amneal. Stay vigilant and report any suspicious activity to Amneal.
Posted 4 months ago
3.0 - 5.0 years
3 - 5 Lacs
ahmedabad
Work from Office
Job Title: Senior IT Administrator Bioanalytical Support Experience: 3-5 Years Job Summary: The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems. Infrastructure & System Support Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems. Administer Windows Server environments, Active Directory, Group Policies, and file/print services. Ensure uptime and performance of systems supporting LC-MS/MS, HPLC, and other analytical instruments. GxP & Compliance Ensure IT systems supporting bioanalytical operations meet GxP, GLP, and FDA 21 CFR Part 11 compliance requirements. Support audits and inspections by providing IT-related documentation, access logs, validation records, and system controls. Assist in Computer System Validation (CSV) and Data Integrity initiatives as per ALCOA+ principles. Application & Lab Systems Support Provide L2/L3 support for laboratory applications such as LIMS , Analyst , Thermo , LabSolutions , or equivalent. Coordinate with instrument vendors and internal QA/RA for software upgrades, patches, and validation. Manage user access and security configurations for lab applications and instruments. Data & Backup Management Oversee automated and manual backup processes for lab-generated data, ensuring integrity and retrievability. Ensure secure, compliant storage of analytical and raw data per regulatory retention policies. User & IT Operations Support Act as the primary IT point of contact for lab users and scientific staff. Troubleshoot lab connectivity, software, printing, and data access issues. Provide training and guidance on compliant IT practices within lab operations. Documentation & Change Control Create and maintain SOPs, user guides, validation protocols, and IT system documentation. Participate in Change Control, Deviation, and CAPA processes involving IT systems. Key Skills & Competencies: Strong understanding of bioanalytical workflows and regulated lab environments. Hands-on expertise in Windows OS, Active Directory, networking, data backup, and IT security. Experience supporting regulated lab software (LIMS, chromatography systems) . Familiarity with Computer System Validation (CSV) , GAMP 5 , and data integrity concepts. Good problem-solving and communication skills. Ability to work under audit-ready, regulated environments.
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