30 Uplc Jobs - Page 2

• Must have experience in analytical method development of peptide molecules. • Experience in method development of peptide molecules and Fmoc-Amino acids by HPLC and UPLC techniques. • Experience in handling of various peptide related analytical methods like AAA(Amino acid analysis), SEC(Size exclusive chromatography), Peptide Assay, Oligomers content. • Knowledge in characterization data of peptides i.e. Amino acid sequencing by LC-MS/MS by Q-Tof, HRMS and NMR. • Experience in handling of routine analysis of peptides by HPLC, GC, ICPMS and wet analysis.

Qualifications: Masters degree in Pharmaceutical Sciences (M. Pharm) or Chemistry (M.Sc) with 4-6 years of hands-on experience. Proficiency in analytical techniques such as HPLC, UV spectroscopy, DSC, Dissolution testing, with expertise in developing analytical methods for drug substances, reference standards (RS), and impurities. Experience in soft gel analysis preferred. Proactive problem solver with a strong ability to identify issues and propose effective solutions. Team-oriented with experience collaborating across functional teams. Strong documentation skills and effective communication abilities. Capable of working independently with minimal supervision. Roles and Responsibilities: Perform laboratory activities adhering to Pharmaceutical GLP/GMP and internal guidelines, ensuring safety and reliability. Conduct analytical testing of dosage forms, focusing on Assay, dissolution, related substances, and other specified tests, particularly for soft gelatin capsules. Perform analytical testing for dosage forms involved in stability studies. Independently execute tasks following in-house SOPs and good documentation practices. Travel to SPIs other locations, customer sites, or contract manufacturing units as needed for method transfer activities. Meet defined priorities, scope, timelines, and deliverables consistently

Job Description :- QC Executive / Sr. Executive Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Benefits Provided: 1 Free Air-Conditioned Transportation to the Factory 2 Paid Leave 3 Tea/Coffee & Canteen Facility 4 Accident Insurance 5 Provision for Bonus & Gratuity 6 Training programs for professional advancement 7 Progressive work environment conducive to personal and professional growth Job Title :- QC Executive / Sr. Executive Role & Responsibility: 1.To follow and ensure Good Laboratory Practices. 2.To perform the work according to work allotment. 3.To follow good documentation practices while making entries in Documents and records. 4.Make sure that materials are appropriately tested and results are reported. 5.To perform the Initiation and review of any change related to the department. 6.Make sure that deviations and Out of Specification Investigation are investigated and solved it with CAPA. 7.To perform the Preparation and review of all SOPs related to department, Specification and test procedures. 8.Preparation and execution of validation protocol for method validation and Analyst validation. 9.SOP Review, revision and Harmonization. 10.To perform the new products analysis method, review and arrange for necessary Corrections in test procedures. 11.To perform the Analytical method, transfer activity and report protocol review. 12.Arranging AMC of Instrument and servicing. 13.To perform the Instrument spare procurement and maintenance. 14.To Review of periodic calibration of Instruments. 15.Reference Standard procurement and management. 16.Monitoring the activity of working standard preparation and managements. 17.In- house training of Analysis and training of corporate training modules. 18.Review Analyst Qualification/ certification. 19.Departmental correspondence, Internal and external Audit compliance action. 20.Co-ordination with maintenance Dept. for QC Dept. utilities and its Maintenance. 21.To Review Qualification of Laboratory Instruments Equipment. 22.Handling Change control, OOS, OOT, Incident and deviation & CAPA. 23.Monitoring stability sample analysis, Microbiology Lab record review. 24.To check pharmaceutical addendum & supplement to make necessary amendment in the specification, whenever change in the Pharmacopoeia is observed. 25.Co-ordination for SCM related activity with IT and QA. 26.Storage of Laboratory data & records. 27.Instrument Data back up, and software users rights. 28.Arranging for outside testing and calibrations and its report Review. 29.To ensure the Approval and Rejection of Raw Material, Packing Material & Intermediates products. 30.Review of analytical results/data of in-process. Intermediate, water analysis finished API and issue COA for each batch of API. 31.Trouble shooting of the QC Instruments 32.If any additional responsibility assigned by senior. 33.To ensure all QC staff do the performance under GLP 34.Any additional job responsibilities as assigned by HOD. Department :- Quality Control Number Of Positions :- 01 Experience :- 3 to 8yrs Employment Type :- Full Time, Permanent Education UG: B.SC in Any Specialization PG : M.SC in Any Specialization Compensation :- As per Industry norms & experience Key Skills :- QC, UV, HPLC, ADL, Analytical, Method Development, Wet Analysis, PH Meter, GLP, Stability Analysis, SOP Review

Role & responsibilities Accountabilities: Responsible for Analytical Method development, Method Validation, Method transfer, Investigation, Regulatory support, Routine analytical and stability study support for API, Intermediates, and different DP formulations with minimal or no supervision. Responsibilities: Responsible for method development and validation for Drug substance and Drug product by using HPLC and UPLC. Responsible for developing cleaning methods and validation for Tuas site. Should be able to perform trouble shooting of analytical challenges which includes method and machine. Adhere both quality and safety compliance according to organizational policies/procedures and regulatory guidance. Perform assessments of existing data packages, feasibilities and conclude remediation. Ensure technical output is compliant with all Global Training Curricula for the instrument operations, material handling and certifications related to, Quality Ops, Manufacturing and EHS. Work with the Quality Assurance and other cross functional teams to facilitate the consistent, disciplined execution of the LIR/ER/CAPA quality system ensuring the completeness and comprehensiveness of the assigned task. Ensures compliance to local and corporate procedures and ensures all data packages are audit ready and transferable. Ensure appropriate GT&E LT review of the formal reports that are considered milestones for decision making. Coordinate with cross functional teams to ensure timely execution and resolution of all deliverables versus target milestones. Preferred Qualifications M.Sc/M.Pharm Types of Experience: Experience in Analytical Research and Development, possesses knowledge of oral solid dosage forms, liquids, semisolids, and API. Understand regulatory expectations and possess exceptional expertise in data interpretation and scientific outputs. Hands on experience in handling HPLC, Dissolution, UV, GC and Wet Chemistry. Equipment: HPLC, GC Wet Chemistry, IC and UPLC

1. Preparation and Maintenance of SOPs, STPS, Specifications, GTP's and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Operation and calibration of QC Instruments related to product testing. 4. 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.) ELISA's (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.) Capillary electrophoresis. 5. Preparation of reagent solutions, buffers and maintenance of the records. 6. Sample receiving, A.R.No allotment, Testing, Documentation and reporting of analytical results and Review in LIMS for In-process, batch release, stability and Miscellaneous samples related to product testing. 7. Withdrawal and aliquoting of batch release and stability samples for analysis. 8. Temperature and humidity monitoring of labs and instruments. 9. Responsible for CGLP compliance. 10. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 11. Maintenance of stability samples and reserve samples related to product testing.