562 Uv Jobs - Page 5

1. Preparation of buffers and other solutions for plasma fractionation process. 2. Batch manufacturing record samples sending to QC for analysis. 3. Performing PHT, CIP and SIP of all the process vessels. 4.Follow shift schedule and production schedule, planning of shifts for the subordinate as per process requirement. 5. Preparation Review of equipment IQ, OQ and PQ documents. 6.To involve in Production planning and execution. 7. To get involved in technical discussion and planning for execution of new product validation batches and commercial batches in plant. 8. To get involved in Batch-to-batch yield analysis and investigation for low yield or OOS routed through Change control or deviation.

1. Preparation of buffers and other solutions inARD lab. 2. Handlingof ARD Equipments. 3. Dataentry in log books, lab note books and DRS. 4. Responsiblefor calibration of pH and conductivity meters. 5. Responsiblefor performing analytical test methods for Human Albumin Solution, Human Normal Immunoglobulin for IntravenousUse and Human Coagulation Factor IX as per MOAs. 6. Monitoringarea cleaning, Glassware and other equipment cleaning activities. 7. Responsibleto check the available stock of chemicals, solvents, raw material etc. 8. Supportother ARD team members. 9. Responsiblefor the preparation of ARD Documents. 10. Need to coordinate with cross functional teams likeDownstream, fractionation and QA etc. 11. Responsible for coordinating with the team as atraining coordinator.

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

End-to-end formulation and development of injectable dosage forms (Liquid, Lyophilized, Emulsion, etc.) Handling of scale-up, exhibit batches, and tech transfer Cross-functional coordination with ADL, RA, QA, and Manufacturing

Planning and executing assay-runs for cell based assays and ELISA as part of Method Development and Method Qualification studies Analysis of the data using parallel line analysis and equivalence testing Writing protocols and reports for Method development and Method qualification studies Maintenance of the cell lines, preparation of cell banks Review of raw data and data recording sheets and to ensure good documentation practices. Planning of day-to-day activities independently. Trouble shooting of the issues (if any) aroused during execution of assay-run. Involving in documents preparation for SOP, STP, MOA.

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS. 4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS. 5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials. 6. Operation and calibration of QC Instruments related to product testing. 7. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.) 8. Preparation of reagent solutions, buffers and maintenance of the records. 9. Temperature and humidity monitoring of labs and instruments. 10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing. 11. Withdrawal and aliquoting of batch release and stability samples for analysis. 12. Responsible for preparation of shift schedules and test planning activities. 13. Responsible for cGLP compliance. 14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 15. Responsible for change management: Ensure CRNs initiation and closure within target date. 16. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 17. Review of analytical data and work sheets related to product testing. 18. Maintenance of stability samples and reserve samples related to product testing. 19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 20. Responsible for usage, monitoring and verification of all kind of laboratory books. 21. Preparation, execution and review of reference standard qualification. 22. Maintenance of all QC documents related to product testing. 23. Assist in execution of Analytical method validations.

1) Development of mass spectrometry based methods for analysis of various molecules for pivotal studies such as biosimilarity, comparability etc.. 2)operation and maintenance of mass spectrometry instrument and performing troubleshooting activities 3)developing and carrying out multiple assays aimed at characterization of protein based therapeutics across various stage of the project 4) participate in design, development and implementation of methods for CQA/impurity characterization of molecules. Interpret results,and draw conclusions from multiple stage experiments 5) Author technical documents such as SOP,MoA,study protocol and reports for method and product development

Design and execute experiments related to the formulation development of oral solid dosage forms using HME techniques. Operate and maintain HME equipment including twin-screw extruders, feeders, and associated downstream processing units (milling, compaction, etc.). Conduct pre-formulation studies, including excipient compatibility and thermal analysis (DSC, TGA). Perform process optimization and scale-up studies for HME-based formulations. Prepare solid dispersions, amorphous systems, and evaluate physical and chemical stability. Perform solid-state characterization using tools such as XRPD, FTIR, Raman spectroscopy, and microscopy.

1) Preparationof Analytical method validation Protocols and reports for the relatedsubstances and Assay by HPLC and residual solvents by GC 2) Preparation of Analytical methodvalidation Protocols and reports for the Identification analysis by HPLC,GC andparticle size analyzer and performing the analytical method validations for theIdentification, content and purity analysis by HPLC,GC and Particle sizeanalyzer. 3) Performing the Analytical methodvalidations by HPLC and GC. 4) R esponsible to follow and ensure strict compliance to GLP practices in the laboratory to meet the organizational goal which in line with procedural references. 5) Maintenance of log books and Calibration records as per procedural references. 6) Preparation of Analytical method validation Protocols and report for the Elemental Impurities analysis by ICP-MS and Perform the analytical method validations for elemental impurities by ICP-MS.

The Junior Analyst/Executive in Analytical Research and Development (ARD) Injectables plays a vital support role in the development and evaluation of sterile pharmaceutical products This position involves performing routine analytical testing of injectable dosage forms such as solutions, lyophilized powders, emulsions, and suspensions using instruments like HPLC, UV-Vis, FTIR, pH meter, and more Under the guidance of senior scientists, the junior analyst assists in method development, validation, and stability studies, ensuring that data is accurate and meets regulatory and internal quality standards Responsibilities include sample preparation, instrument handling, maintaining laboratory notebooks, and following Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) The role also includes preparing reagents, calibrating instruments, and maintaining documentation for analytical procedures and observations Junior analysts support data compilation for regulatory submissions and assist in investigations related to analytical deviations or out-of-specification results They collaborate with cross-functional teams such as Formulation RD, QA, and Regulatory Affairs to ensure timely and compliant development activities This position requires attention to detail, a willingness to learn, and the ability to follow procedures precisely Ideal candidates should hold a Pharm, MPharm (Pharmaceutical Analysis or Pharmaceutics

The candidate would be developing various analytical method (such as CD, Fluorescence spectrscopy ,CE UH/HPLC etc..)for CQA to support biosimilarity and analytical studies. Qualify method for biosimilarity and analytical studies. Responsible for performing biosimilarity, characterization and analytical studies for various molecules across lifecycle . Evaluation, interpretation and graphical representation of the measurement data as well as presentation of the results obtained from multiple experiments. Author technical documents such as MoA,MQR,SOP,study protocol and report.

Development and validation of analytical methods for injectable dosage forms Stability study execution and data interpretation Support for formulation development and regulatory submissions (US/EU) Instrument handling: HPLC, GC, UV, KF, etc. Preparation of method validation reports, protocols, and SOPs

1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.

1. Receipt, storage and usage of medias, Microbial cultures, materials and documentation 2. Perform viable / non-viable monitoring activities, media plates observations and documentation in testing facilities. 3. Environmental monitoring, sampling, receipt, testing and documentation of all Microbiology samples. 4. Perform cleaning, fumigation and other activities in Microbiology laboratory. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Preparation of dilute disinfectants, reagents solutions / indicator solutions. 7. Responsible for compliance to cGLP. 8. Operation and usage of instruments. 9. Execution of method validations / method verification samples. 10. Receipt / testing of validation samples from manufacturing / other areas 11. Training and qualification of analysts in Microbiology department. 12. Responsible for handling of Bio-waste in Microbiology department. 13. Review, checking and verification Microbiology laboratory documents. 14. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;

Operation and calibration of QC Instruments related to product testing. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD at 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycan by hydrophilic liquid interaction chromatography, Peptide mapping, Size exclusion chromatography etc.) Capillary electrophoresis. Temperature and humidity monitoring of labs and instruments. Responsible for cGLP compliance. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. Responsible for usage, monitoring and verification of all kinds of laboratory books. Assist in execution of Analytical method validations

1. Follow SOPs, GMP and safety practices. 2. Facility Area cleaning, Equipment cleaning, drains cleaning sanitization. 70 % IPA arrangement. Discarding general waste, rejects and biowaste. Log books updation. Spillage management. Updating of BMRs and annexures online. 3. Material Arrangement of plastic / glassware. Material packing for sterilization. Arrangement of garments. Arrangement of materials. 4. Process Arrangement of drums and installation of bags. Collection of WFI. Movement of prepared media/buffer to process rooms. Assisting in cleaning of equipments. Movement of samples. Execution of production activities. Monitoring of batch parameters. Arrangement of HDPE Drums, Vessels and installation of SUM bags and liner bags. Samples handling (Sampling and labelling). Handling of Depth filters assembly and harvest activities. Media Buffer preparation activities for process. LN2 container handling for filling activities. 5. Participate in training programs as per training schedule. 6. Responsible for operation of following production equipments (but not limited to): Mixing systems Weighing balance Magnetic stirrer Peristaltic pumps pH meter Cold Room Freezer Heat exchanger Depth filter holders Laminar air flow cabinet Biosafety cabinet Pass box LN2 container

Responsible for production activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room Training: Attending training on SOP's / GMP as per schedule.

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

Eligibility : M.Sc / M.tech (Life Sciences / Biotechnology) Technical Skills : Various Extraction Techniques Purification techniques Phytochemical Activity (Qualitative quantitative) HPLC CG AAS FTIR UV-Vis Spectrophotometer General Skills : Complete knowledge of MS Office Standardisation of SOP Sample flow management English (Reading and Writing) Candidate must have a personal Laptop

Job Title: Quality Control Head Industry: API / Pharma Manufacturing Job Location: Ankleshwar, Gujarat Experience Required: 15 to 20 years of relevant experience in Quality Control within the API pharma industry Salary: 12.0 LPA to ?15.0 LPA Education: M.Sc. / B.Sc. (Chemistry) or M.Pharm / B.Pharm or equivalent Key Skills Required: Strong knowledge of data integrity principles Hands-on experience with instruments like HPLC, GC, and UV Experience in cleaning validation and microbiological testing Familiarity with incident investigations and regulatory compliance About the Company: A leading API pharma manufacturing group known for its strong global presence and commitment to quality and innovation. Job Responsibilities: Lead and manage the Quality Control (QC) department to ensure quality at every stage of manufacturing and testing. Oversee sampling, inspection, and testing of raw materials, packaging materials, in-process, and finished products. Ensure timely release or rejection of batches based on quality data. Handle stability chamber management, testing, and shelf-life evaluations as per protocol. Conduct microbiological analysis for raw materials, finished goods, water, and environmental monitoring. Review trends in physicochemical and microbiological test data for compliance. Manage out-of-specification (OOS), deviation investigations, and analytical support for product recalls and complaints. Coordinate with QA and R&D on specifications, analytical procedures, and validations. Ensure equipment/instrument qualification, calibration, and preventive maintenance. Maintain and audit QC records, reference/working standards, and ensure data integrity systems are in place. Supervise glassware cleaning, protocol validation, and implementation of cleaning procedures. Plan and execute internal audits and ensure compliance with GLP and GMP standards. Review and validate SOPs, protocols, and test methods (pharmacopeial & in-house). Support employee training in alignment with cGLP and cGMP practices. Evaluate change control proposals, failure investigations, market complaints, and implement improvements in QC systems. Ensure all activities follow company reporting systems and regulatory expectations.

1) Experience in preparing and reviewing of Method Development Report. 2) Knowledge of ICH Guidelines. 3) Strategic planning and performing Validation studies, Solubility Studies, Impurity and Standard Qualification. 4) Exposure of working on HPLC, LCMS, GC, UV and other equipment. 5) Ability to perform an analysis of related substances, assays and purity by using HPLC, IC. 6) Ability to perform analysis of residual solvents by using gas Chromatography. 7) Preparation and Review of development and validation/ method transfers/ protocols and reports based on R&D qualifications or monographs. 8) Ability to work in a team and contribute towards collective goals.

Role Finance and Administration CSR: 360 degree CFO Like responsibility in running functions and entities Will be responsible for managing accounts, compliances and Tax for ~ 3 not for profit entities Will support financial reporting for CSR Hybrid work structure for work life balance Requirement CA with 5-7 years of experience Deep understanding of financial, legal, tax and compliances matter .

Role: Officer - Quality Control / Quality Assurance Job Location: Nashik At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role Purpose We have Openings in Both QC and QA(IPQA / Documentation / QMS / AQA) . Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP. Role & responsibilities Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure. To maintain documents as per GLP requirements. To ensure the calibration status of laboratory equipment & instruments. To report and involve in incidence/Deviation/OOS/OOT investigations. Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements. To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications. Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise. To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable. To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 1 to 4 years experience in a reputed pharma industry. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

The job requires a candidate with 2 to 7 years of experience in Analytical Chemistry for a position at a Chemical Manufacturing Company's Pharma Division in Ahmedabad. The salary ranges from Rs. 35,000 to Rs. 40,000 per month based on the candidate's knowledge. The responsibilities include handling analytical instruments such as HPLC, GC, UV, IR, performing instrument calibration, analyzing finished products and raw materials, and conducting wet lab analysis. The job type is full-time and requires in-person work at the specified location. Contact person for the position is Gopi (HR) reachable at 7777981971.,