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3.0 - 5.0 years
1 - 4 Lacs
Choutuppal, Hyderabad
Work from Office
Research and development Required Candidate profile Quality Control
Posted 1 week ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Quality Control Department In Formulation Division @ Bollaram Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSNF-II , Kothur | MSNF-V, Rk Puram Venue Location:- Plot No- 42, Anrich Industrial Estate, Bollaram Village, Hyderabad, Telangana 502325 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 1 week ago
3.0 - 6.0 years
6 - 9 Lacs
Ankleshwar
Work from Office
Qualification - Msc Chemistry - 3- 6 Yrs Experience Experience of GC / HPLC Preferred . Experience in Zydus : Min.12 months Job Responsibilities o Handling of HPLC system /GC o Up-keep of all Instrument Usage Log,Inward Register, Training Records etc. o Usage of SOPs, Specifications and STPfor Inprocess, Intermediate, FiniAsh Product, Recovered Solvents, and CleaningSample. o Handling of LIMS for Receiving ofsample along with Intimation Slip for Inprocess, Intermediate, Finish Product,Recovered Solvents, Cleaning Sample and outside sample etc. and testing as pertheir Specification and STP. o To follow the GMP, Safety norms andadhere to companys policy. o Attending Training classes i.e.Internal and External program as per schedule. Usage of SOPs, Specificationsand STP for Inprocess, Intermediate, Finish Product, Recovered Solvents, andCleaning Sample. o Receiving of sample along withIntimation Slip for Inprocess, Intermediate, Finish Product, RecoveredSolvents, Cleaning Sample and outside sample etc. and testing as per theirSpecification and STP. o After analysing and writinganalytical data, hander over the raw data to senior person for review. o Timely reporting of results andinvestigation of any deviation, OOS, incident. Maintain house-keeping and GLPin working area. o Additional Job activities endorsed bySuperior.
Posted 2 weeks ago
5.0 - 10.0 years
13 - 17 Lacs
Ahmedabad
Work from Office
Department: Analytical Development Injectables / Complex Injectables US Market Job Description: Method Development of Drug Product and Method verification of Raw Materials using HPLC, UHPLC with sound knowledge of Chromeleon & Lab solution software. To perform analysis of Drug Product and Drug Substances for various test parameters and as per the product development requirement. Compilation of analytical results and preparation Method Development Report. Literature survey to support method development of Drug product and characterization activity of Drug product. Compilation and monitoring of routine and stability analysis data. Support to formulation team to develop the drug product.
Posted 2 weeks ago
2.0 - 5.0 years
7 - 11 Lacs
Hyderabad
Work from Office
Overview Monitor market category, customer and competitor performance across key AMESA markets and execute scorecard reporting for top customers at required intervals and generate scorecards and performance overviews (quarterly/adhoc for key customers) for the categories and customers Leverage multiple data sources (Nielsen/IRI, Household panel data, Customer scan/loyalty data) and market/customer understanding, to support AMESA DX Supports in the creation and driving of winning execution strategies in-store with customers. Identifies sales opportunities and optimization tactics to drive category demand, space and shopper KPIs Analyze and prepare reports on Promotions and NPD performance and benchmarking in external views (Nielsen, dunnhumby etc.) to measure and optimize, to drive category growth Able to collaborate and work with BU teams and external third party agencies to acquire information and resolve any service issues on projects Responsibilities Ability to work in diverse teams Language skills English business fluent Possess ability to analyze & benchmark competitive scenarios Excellent written and oral communication skills; consistently communicates using appropriate methods for situation and audience in clear, concise and professional manner Ability to work collaboratively and proactively with multi-functional teams Be flexible, organized and able to handle competing priorities Qualifications Bachelors' degree in Business, Marketing, EngineeringMBA a plus 4yrs+ insights/ analytics Prior FMCG experience Knowledge of Nielsen, Household Panel, dunnhumby Advanced Microsoft Office / PowerPoint & Excel skills Can synthesize multiple disparate data sources into compelling growth strategies/reviews Can easily see how insights and research learnings can improve business and frames up reporting efforts and opportunities to inform business decisions
Posted 2 weeks ago
4.0 - 7.0 years
5 - 7 Lacs
Visakhapatnam
Work from Office
For day to day sample extractions & instrument (LCMS/MS - GCMS/MS) sequencing Roles and Responsibilities Testing of various agriculture and food products for chemical and nutritional testing by standard and in-house methods Hands on expireance in Proximate Analysis Operating the lab instruments like pH meter, weighing balance, incubator, GCMS/MS & LCMS/MS, UPLC Preparation of standard solutions Daily maintenance of lab equipment. Following good laboratory practices Following disposal process for samples & solutions as per SOP. Accurate analysis and interpretation of test results Maintenance of laboratory documents and records Validation of methods and calibration/verification of instruments Ensuring purity and validity of CRMs Conduct sensory evaluations of food samples
Posted 2 weeks ago
9.0 - 12.0 years
18 - 25 Lacs
Bengaluru
Work from Office
Job description: Leadership role to manage team size of 10+ scientists (Ph.D. and M.Sc.) Extensive knowledge in E&L Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines Managing multiple instruments (LC-MSMS, GC-MSMS, ICP-MS, IC etc.) Method development experience in LC-MSMS, GC-MSMS and ICPMS instrument Preparation and Implementation of SOPs related to E& L , general laboratory processes and best guidance. Good knowledge of 21 CFR part 11, Data Integrity principals, good documentation practices in cGMP lab Monitor and management of day-to-day laboratory activities Extensive knowledge of preparation, reviewing and approval capability for standard operating procedure (SOP) and COA Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS etc. Resolving the team conflicts and provide training to the team for development and empowers team members Provide scientific and leadership direction to team members Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab. Skills Required: For M.Sc, 16-18 years of Discovery Analytical R&D experience and for PhD, 14-16 years of experience in CRO environment Excellent technical, problem-solving, writing, influencing and communication skills Strong leadership with excellent interpersonal skills, proven success of analytical projects and managing cross functional teams Demonstrative communication skills and confident in conveying information to internal/ external customers Skill for resolving the team conflicts and provide training to the team for development and empowers team members Behavioral Competencies: Excellent oral / written communication skills and flexibility to work in a dynamic environment Excellent in Knowledge sharing at all levels Qualifications Qualification M.Sc./PhD/Postdoc Additional Information Specialization Analytical Chemistry/Organic Chemistry, Department E&L Experience (years) 16 - 20
Posted 2 weeks ago
0.0 - 3.0 years
6 - 7 Lacs
Bengaluru
Work from Office
Functional or Technical skills JOB DESCRIPTION Job Role : Analytical Chemistry-Analyst Department : Analytical - BGRC 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. 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: This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, etc. Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers Shall have experience on Good documentation/laboratory practices such as ALCOA+. Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control). Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards / Chemicals / Reagents / Consumables / Spares etc., required for the projects Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas. Behavioural Skills Good Interpersonal skills Self-time management Good team player Good communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 0-3 years Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-visible spectrophotometer, Potentiometer, and QC other analytical instruments Theoretical knowledge in Chromatography and spectroscopy technique Good documentation/laboratory practices such as ALCOA+. Able to follow work instructions and perform the tasks under the supervision of the Team leader Preparation and Maintenance of all the documents Good knowledge of MS-office (word, excel, ppt) Education M. Pharm/ M. Tech/ M.Sc. / B.Tech., B.Sc. (Analytical chemistry/Chemistry) with 0-3 years Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Posted 2 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Quality Control Department In Formulation Division @ Vizag Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- Hotel Cygnett Inn Ramachandra , 31-2-4/5, NH16, opp. All India Radio Station, Kurmannapalem, Visakhapatnam, Andhra Pradesh 530046 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 2 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Quality Control Department In Formulation Division @ Jadcherla Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 01-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- ELITE HOTELS & RESORTSNH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 3 weeks ago
0.0 - 3.0 years
2 - 3 Lacs
Ahmedabad
Work from Office
Ensuring the quality of APIs through testing, analysis, & documentation Sample & inspect raw materials Maintain an accurate & complete record of testing, analysis Investigate deviations from the quality standard Ensure compliance with GMP regulations Required Candidate profile Bachelor's degree in B.Sc/M.Sc Chemistry, B.Pharm/M.Pharm. Previous experience in QC in API pharma manufacturing Strong knowledge of analytical techniques & instrumentation, e.g., HPLC, GC, UV-Vis
Posted 3 weeks ago
2 - 6 years
4 - 6 Lacs
Nalagarh, Baddi
Work from Office
Responsible for conducting various chemical analyses, ensuring the safety and compliance of waste handling procedures, and contributing to the optimization of waste management processes. Exp: 2 to 5 years Salary : 5-7LPA Location : Baddi/Nalaghare
Posted 2 months ago
3 - 8 years
6 - 12 Lacs
Hyderabad
Work from Office
Role : Research Associate/ Sr. Research Associate - CMC (Analytical) Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Qualification : M. Pharma/M.Sc. in Pharmaceutical Analysis/ Pharmaceutical Chemistry from reputed University. Experience : Around 3 to 8 years of experience in analytical method development, method validation for formulations. Purpose of the Role : Work both as an individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Job Description : Carry out Analytical method development and pre-validation involved in assigned projects, protocols & reports, in compliance with Ferring QMS to achieve the objectives as per project requirements. Author and review Analytical documents, not limited to method development reports, justification reports etc., to be built on strong scientific rationale, study designs & compliance with ICH, compendial & regulatory guidelines. Carry out & ensure Analytical deliverables for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements. Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements. Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements. Managing stability study related activities for assigned projects to achieve the objectives as per project requirements. Ensure external analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements. Carry out literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements. Review of ELN experiments, Data, Reports and documents generated within lab & those received from CRO/CMO in line with defined quality standards. Support procurement activities related to project & laboratory i.e. vendor contact, URS, SOW etc. in line with defined quality standards. Coordinating with Facility/Vendor for instruments and equipment AM, PM and regular maintenance in Analytical lab in line with defined quality standard. Preferred Competencies in the role. Working experience with diverse dosage form and differentiated products preferred. Timely achievement of the project deliverables GDP/GLP compliance ensured for data, lab operations & processes. Sound scientific & communication skills Strong Leadership Skills Critical thinking, troubleshooting and problem-solving skills. Engagement & accountability towards the defined purpose Good team player
Posted 2 months ago
2 - 4 years
3 - 6 Lacs
Bengaluru
Work from Office
Role & responsibilities 1. Analytical Testing and Analysis : a. Analyze samples from various sources (raw materials, intermediates, finished products, and stability samples) to determine compound composition and quantities. b. Perform routine and complex analyses using HPLC, Prep HPLC, LCMS, UPLC, and Flash chromatography. c. Interpret analytical data and provide comprehensive reports of scientific results, including trend analysis and data summaries. d. Conduct testing, release, and documentation of raw materials, intermediates, and finished products, adhering to established specifications. e. Perform stability studies and analyze degradation products. 2. Method Development and Validation: a. Develop and validate HPLC, LCMS, and other analytical methods for various drug products and chemical compounds, including forced degradation studies. b. Ensure methods are robust, reliable, and compliant with regulatory requirements (ICH guidelines, etc.). c. Write and review method validation protocols and reports. 3. Instrument Management and Documentation: a. Perform routine calibration, maintenance, and troubleshooting of HPLC, LCMS, GC, and other analytical instruments. b. Prepare and maintain Standard Operating Procedures (SOPs) and Instrument Operating Procedures (IOPs). c. Maintain accurate and detailed documentation of all analytical activities, including raw data, instrument logs, and reports, in accordance with GLP/GMP. d. Participate in instrument qualification. 4. Quality Control and Compliance: a. Ensure all analytical activities comply with established quality control procedures and regulatory guidelines. b. Maintain awareness of and adhere to health and safety regulations, including chemical handling and waste disposal. c. Validate methods and equipment to ensure accuracy and reliability, participating in audits as needed. d. (Optional) Ensure compliance with cGMP and GLP guidelines. e. Participate in investigations of out-of-specification (OOS) results. 5. Collaboration and Communication: a. Work collaboratively in cross-functional teams, including R&D, formulation, and regulatory affairs. b. Liaise with customers, staff, and suppliers as needed. c. Report scientific results effectively to stakeholders, including presentations and written reports. d. Participate in project meetings. Preferred candidate profile Technical Skills: a. Extensive hands-on experience with HPLC, Prep HPLC, LCMS, UPLC, and Flash chromatography. b. Proven experience in developing and validating HPLC and LCMS methods. c. Knowledge of instrument calibration, maintenance, and troubleshooting. d. Proficiency in data interpretation, statistical analysis, and documentation. e. Knowledge of stability testing. Knowledge: a. Strong understanding of analytical chemistry principles and techniques. b. Knowledge of raw materials, intermediates, finished product, and stability testing. c. Knowledge of preparing SOPs, IOPs, validation protocols, and reports. d. Knowledge of regulatory guidelines (ICH, etc.). e. (Optional) Knowledge of cGMP and GLP compliance. Soft Skills: a. Excellent analytical and problem-solving skills. b. Strong attention to detail and ability to maintain meticulous records. c. Excellent communication skills (both written and verbal). d. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). e. Ability to work independently and manage multiple tasks effectively. f. Strong team player Key Attributes: a. Accuracy and reliability in analytical work. b. Commitment to quality, compliance, and safety. c. Proactive and adaptable to new challenges and technologies. d. Strong organizational and time-management skills. e. Ability to learn and keep up to date with new analytical techniques and regulatory requirements. f. Ethical conduct. Perks and benefits
Posted 2 months ago
3 - 6 years
0 - 0 Lacs
Ahmedabad
Work from Office
Chromatographic skills like SEC, IEX, HIC, RP, etc with operation of HPLC, UPLC equipments. N-Glycan analysis is preferred and higher order structure analysis experience will be advantage. Electrophoresis skills like Capillary electrophoresis (cIEF, CE-SDS NR & R, CE-LIF) etc. Work experience on analytical method development and validation for biotherapeutic products. Experience on documentation preparations like SOPs, MOA, MDR, etc. Computer literacy in Microsoft office and softwares related to critical equipments
Posted 2 months ago
6 - 10 years
20 - 27 Lacs
Gurgaon
Work from Office
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Posted 2 months ago
2 - 6 years
2 - 4 Lacs
Alathur
Work from Office
Company: Strides Pharma Department: Quality Control Position: Executive Job Location: KRSG Plant, Alathur Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 2 to 6 Years Key skills: • Analysis of Material / Product by referring current version of specification STP with relevant material code. • Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage • Log / LIMS. • Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products • Tests as per SOP/STP. • Proper handling of chromatographic column used for analysis. • Maintain data integrity and appropriate traceability
Posted 2 months ago
3 - 8 years
5 - 12 Lacs
Hyderabad
Work from Office
Role & responsibilities Responsible to receive, register and analyze batch samples and stability samples. Responsible to prepare reagents, buffers and test solutions as and when required. Responsible to operate, calibrate/ verify/ qualify HPLC, UPLC instruments. Responsible to execute the Analytical Method validations/verifications/Transfers Responsible to prepare SOPs, STPs, Protocols and other GMP documents Responsible to interpret and record the data / results accurately and contemporaneously. Responsible to report to superior any abnormalities found during routine activities Responsible to follow Hygiene, Safety, SOPs, GLP, GMP and GDP. Preferred candidate profile Adequate testing knowledge on Biologics/Monoclonal Antibodies Capillary Electrophoresis : CESDS-R, CESDS-NR HPLC : RP, SEC, Glycan, CEX, Ion exchange chromatography and Polysorbate 20 Maurice : charge variants by iCEF UPLC : Peptide mapping. Qualification and Experience : MSc Biotechnology/Biochemistry/Microbiology with 03-07 Years experience of Biosimilars/Biologics QC.
Posted 3 months ago
2 - 6 years
2 - 4 Lacs
Bangalore Rural, Bengaluru
Work from Office
Company: Strides Pharma Department: Quality Control Position: Executive Job Location: KRSG Plant, Bangalore Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 2 to 6 Years Key skills: • Analysis of Material / Product by referring current version of specification STP with relevant material code. • Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage • Log / LIMS. • Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products • Tests as per SOP/STP. • Proper handling of chromatographic column used for analysis. • Maintain data integrity and appropriate traceability
Posted 3 months ago
4 - 8 years
4 - 9 Lacs
Ahmedabad
Work from Office
Role & responsibilities Reverse Engineering of Formulations: Perform reverse engineering of reference-listed drugs (RLDs) and identify composition, excipients, and active ingredients . Utilize advanced analytical techniques for component identification and quantification. Analytical Method Development & Validation: Develop and validate HPLC, UPLC, GC, LC-MS, FTIR, UV, NMR, XRD, and DSC methods for comparative studies. Characterize excipients, degradation products, and impurities in formulations. Comparative Dissolution & Physicochemical Characterization: Conduct comparative dissolution profiling with RLD as per regulatory guidelines. Study particle size, polymorphism, stability, and compatibility of drug formulations. Regulatory Compliance & Documentation: Prepare analytical reports, method validation protocols, and regulatory documents for ANDA, USFDA, MHRA, EU-GMP submissions. Ensure compliance with ICH, USP, EP, JP, and WHO guidelines. Technology Transfer & Troubleshooting: Support technology transfer for scale-up and commercialization. Assist in troubleshooting analytical challenges during formulation development . Key Skills & Competencies: Expertise in HPLC /UPLC / GC / LC-MS / FTIR / NMR/ XRD/ DSC Knowledge of polymorphism, solubility, permeability, and excipient compatibility Experience in reverse engineering & impurity profiling Strong understanding of ICH Q2 (R1), USFDA, and regulatory guidelines Hands-on experience in GMP, GLP, and stability studies Preferred candidate profile M. Pharmacy / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry / Organic Chemistry) Perks and benefits As Per Company Policy
Posted 3 months ago
3 - 8 years
3 - 8 Lacs
Chennai, Bengaluru, Hyderabad
Work from Office
• 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.
Posted 3 months ago
4 - 6 years
6 - 8 Lacs
Bengaluru
Work from Office
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
Posted 3 months ago
3 - 8 years
3 - 6 Lacs
Sanand, Ahmedabad
Work from Office
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
Posted 3 months ago
7 - 10 years
5 - 9 Lacs
Chennai
Work from Office
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
Posted 3 months ago
4 - 9 years
5 - 10 Lacs
Jadcherla
Work from Office
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.
Posted 3 months ago
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