356 Method Validation Jobs - Page 4

Exp: 2- 6 yrs • Knowledge in Method Development on Assay, RS, dissolution for formulation complex molecules. • understanding of Q1/Q2 evaluation • PEQ processes and characterization • Instruments: HPLC, GC, KF, UV, IR, etc. pranathi.p@orbicular.co.in

Aspirant should have experience in GC-MS Caliber to handle Method Development, Validation, and Stability studies. Regulatory requirements (like USFDA, MHRA, EMA, and other Markets) Coordinating with the Should have GLP, ALCOA+, GDP, QMS

Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis 32S/32P Reference Standards 32S/32P Characterization of Impurities 32S/32P Justification of Specification 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification report based on the performance of material at test. To prepare justification reports towards reduction of tests in Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing. Preparation/Review of SOPs Preparation of cleaning validation method protocol and report Required Skills Data Integrity (ALCOA+ principles) | Advanced Regulatory knowledge (USFDA, MHRA, ICH Q series) | Advanced Method Validation Documentation | Advanced Method Development Understanding | Advanced CTD / eCTD Module Preparation (Primarily Module 3.2.S & 3.2.P) | Advanced

NOTE: Only Male & Candidates from AP & Telangana Preferred. Kindly Understand the JD It's not for the Clinical Trails Department 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Qualifications required: Bachelors / Master's in Pharmacy, M.sc Chemistry/Organic Chemistry (2023/24/25 Passed outs with certificates in hand) Role and responsibility: In process quality control of ongoing studies. Review of raw data, chromatograms and reports of the method validations and studies. Checking of all the instruments and equipments for the calibration status and appropriate labeling. Checking and monitoring of the day-to-day activities in the lab for compliance to SOPs and GLP principles. Checking of the concentration data of subject samples before releasing to PK department. Generation, control and distribution of method SOPs. Logbook handling and archival of the completed logbooks. Performing the routine glassware validations and monitoring of the temperature and humidity in the Bio-analytical lab. Calibration of pipettes and multipedes. Coordinating for training programs on SOPs. Ensure cleanliness of laboratory and disposal of non-bio-waste & Bio-waste.

As a member of our team, your primary responsibilities will include the development and validation of methods for Assay, Dissolution, and related substances. You will also be responsible for the calibration of analytical instruments to ensure accurate and reliable results. Conducting routine and stability samples analysis of OSD formulations will be a key part of your role. To excel in this position, you must possess a good quality mindset and have a thorough understanding of GLP requirements. Your ability to write technical reports and prepare power point presentations will be essential for effectively communicating your findings and recommendations. Join us in this dynamic role where you will play a crucial part in ensuring the quality and accuracy of our analytical processes.,

You will be joining USP's Global Biologics department as a Sr. Scientist - I (RSS-Review), where you will play a crucial role in supporting the development of USP documentary standards and reference standards for biological products. In this hands-on, non-supervisory position, you will be responsible for ensuring the accuracy, clarity, and compliance of scientific documents, managing the reference standard stability program, and driving continuous process improvements. Your primary responsibilities will include performing technical and quality reviews of documents, developing and reviewing SOPs and training materials, assisting in investigations of quality-related issues, and collaborating with internal stakeholders to develop new standards for analytical analysis of biological products. You will also be involved in maintaining the reference standard stability program, reviewing testing data, preparing stability trend reports, and updating databases to document laboratory data and program determinations. To succeed in this role, you must have a PhD degree in Biochemistry/Biology/Pharmacy or a related field with 7 to 10 years of experience, or a Master's degree with 11 to 13 years of experience. You should have demonstrated expertise in technical review of analytical documents in Quality Assurance and hands-on experience with analytical techniques for characterizing biological products. Strong communication skills, both written and verbal, along with the ability to work collaboratively with internal and external stakeholders, are essential for this position. Additionally, knowledge of USP products and services, experience in the pharmaceutical or biotechnology industry, and the ability to work effectively in a fast-paced environment are desired preferences. While there are no supervisory responsibilities associated with this role, you will be expected to take ownership of your work, ensure timely delivery of tasks, and maintain the highest quality standards. USP is committed to providing comprehensive benefits to protect the well-being of you and your family, including paid time off, healthcare options, and retirement savings. By joining USP, you will contribute to the organization's mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs.,

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Procedures, Validation Protocols and Reports, Certificates of Analysis, stability protocols, and reports. You will also be responsible for reviewing vendor documents related to API, Excipients, and Packing materials to ensure adequacy and compliance. Furthermore, you will be involved in the preparation, review, and compilation of ANDAs, Amendments, and Supplements in eCTD format. Collaboration with the Regulatory Operation team member for uploading submissions in eCTD software and reviewing exported submissions for submission will be part of your routine tasks. It is also essential to monitor the FDA website for any updates. To qualify for this role, you should possess a Master of Pharmacy in the Department of Pharmaceutics and have at least 3-5 years of experience in Regulatory Affairs.,

SENIOR QUALITY CONTROL ANALYST Job Objective: The Quality Control (QC) Analyst specializing in Method Validation and Method Development is responsible for developing, validating, and transferring analytical methods for pharmaceutical raw materials, intermediates, and finished products. The role ensures compliance with regulatory requirements and contributes to continuous improvements in analytical methodologies. Qualifications: Bachelors/Masters degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or related field. Experience: More than 8 years of experience in method validation, method transfer, and regulatory compliance within a pharmaceutical QC or analytical development environment. Job Responsibilities: Method Development & Optimization: Develop and optimize analytical methods for assay, dissolution, related substances, and residual solvents using techniques like HPLC, GC, UV-Vis, FTIR. Establish and refine chromatographic conditions, mobile phases, and detection parameters for improved sensitivity and reproducibility. Conduct forced degradation and stability-indicating method development as per ICH Q1A guidelines. Method Validation & Transfer: Perform method validation as per ICH guidelines covering accuracy, precision, specificity, linearity, robustness, and system suitability. Prepare and review method validation protocols and reports. Execute method transfer activities between R&D, QC, and manufacturing sites following GMP requirements. Regulatory Compliance & Documentation: Ensure analytical methods meet US FDA, EU GMP, MHRA, WHO, and other regulatory expectations. Maintain accurate documentation as per Good Documentation Practices (GDP). Support regulatory filings by preparing analytical method validation reports and technical dossiers. Assist in responding to regulatory queries and audits related to analytical methods. Instrumentation & Troubleshooting: Operate and maintain analytical instruments such as HPLC, GC, UV-Vis, FTIR, and dissolution testers. Troubleshoot chromatographic issues related to retention time shifts, peak tailing, and resolution problems. Participate in instrument qualification (IQ/OQ/PQ) as needed. Collaboration & Process Improvement: Work closely with R&D, Manufacturing, and Quality Assurance teams for seamless method transfer. Investigate out-of-specification (OOS) and out-of-trend (OOT) results to identify root causes. Contribute to continuous improvements in analytical techniques and laboratory efficiency. Technical Skills: Strong expertise in HPLC, GC, UV-Vis, FTIR

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. 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 SOP"™s 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

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. : Medicinal chemistry; Research and development; Literature search; Scifinder / Reaxys; Design and synthesis; combiflash/Biotage; C-C coupling etc Qualifications MSC - Organic Chemistry.

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Job description: Planning/performing and reporting of acute toxicology studies Assist in preparation of SOP"™s, Protocols and Reports Participate in GLP / AAALAC related activities Literature search Maintenance of animal house and relevant documents as per GLP and AAALAC norms. To Assist and work along with SD and TC in Planning, initiation and conduct studies. Test item administration, dose formulation preparation and blood collection. Assistance in data collection, compilation and verification. Participate in GLP inspections and ensure relevant regulatory compliance guidelines. Support in interpretation and reporting of study data. Assist in report preparation and coordination of activities. Assist in archiving of all study related materials. Skills Required: Understanding of the agrochemical and pharmaceutical R&D process Behavioral Competencies: Good in oral / written communication skills. If you're interested in applying or learning more, send your updated resume to [email protected] with the subject line "Research Scientist/Senior Research Scientist - Acute "“ Toxicology - Bangalore". Qualifications Qualification M.Sc. in Zoology/Biosciences Additional Information Specialization Toxicology Department Acute "“ Toxicology Experience (years) 2 to 8 only

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. The Project Manager Assistant (PMA) position is an administrative role working directly with a group of Project Managers, focusing on a specific area of the business. This role requires the use of technical functions to navigate Eurofins Lancaster Labs"™ (ELLI) information systems, construct and develop relationships with ELLI"™s internal scientific and support departments, and assist project managers with a variety of tasks to allow the PMs to focus on client communication. Please note that this position does require direct client interaction. This is a great role if you also aspire to move into a PM position in the future. Employee Responsibilities: Support Sample and Project Management in building and maintaining studies including entering and review of material items, study start and end dates, and generating project plans for the PM teams. Managing incoming and in house Reference Standards by reaching out to the client for updated CoAs when expirations are approaching. Working with Pricing and Analytical Definition to generate quotes and build templates for sample entry of incoming samples. Track financial aspects of projects including purchase order and invoice management. This may also include generating Change Orders, special invoice requests and potentially End of Month billing for clients that qualify. Support Project Managers in an administrative capacity with a variety of other assignments Qualifications M. Pharm / M.Sc, Analyitical Chemistry PMP certification would be an additional advantage Additional Information Experience Level : 5 - 7 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Possesses excellent communication skills "“ both oral and written Has a strong organization and attention to detail Computer skills "“ Experience utilizing MS Office and MS Project or other project organization tools. Experience navigating a LIMS or equivalent is a plus Ability to learn new techniques, perform and prioritize multiple tasks simultaneously, keep accurate records, follow instructions, and comply with agency and company policies (GMP knowledge is a plus) Ability to work both independently and as part of a team, be self-motivated, adaptable, and maintain a positive attitude, even with critical deadlines Initiative/ Self-Starter "“ proactively seek out work and training opportunities, offer to assist others, strive for high productivity and output in a fast-paced environment

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.

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.

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical accuracy. Support regulatory query responses related to product development and manufacturing in collaboration with relevant departments. Lead technology transfer of HFA-based MDIs to contract manufacturing organizations (CMOs) for domestic and international markets. Provide technical and regulatory support for submissions including NDA, ANDA, and 505(b)(2) applications. Troubleshoot formulation-related issues during manufacturing to ensure smooth and compliant commercial production.

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. 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;

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;

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

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.

Food Tech -calibration ,maintenance and inter of LC-MS,GC-MS method validations and method verification for food and water samples, testing peptides, residue, antibiotics, water samples and water samples using GC-MSMS &LC-MSMS

Develop analytical methods for biochemistry samples using GC-MS, LC-MS, and other relevant techniques. method validation, optimization, and transfer to ensure accuracy and reliability of results. data analysis, and reporting in accordance .

The job is based in Hyderabad and is suitable for freshers. Qualifications required are B.Pharm / M.Sc. / M.Pharm. Preferred skills include good communication and analytical skills, as well as the ability to work well in a team in order to complete tasks in a timely manner. The detailed responsibilities of the role include bioanalytical sample preparation using various extraction techniques, conducting method development, method validation, and sample analysis in accordance with regulatory requirements, operating laboratory equipment such as pipettes, centrifuges, evaporators, and extractors, as well as handling data generation, compilation, and reporting of results.,

You will be joining the Bio Analytical Department at PTC - MORAIYA as a Probationer-R&D Executive. With 2-3 years of experience and an educational background in M.Sc or B. Pharma, you will be responsible for various tasks including sample preparation, method development, method validation, and subject sample analysis. Your role will involve operating, calibrating, and maintaining equipment while keeping track of the equipment log. You will also be required to review bio analytical data, prepare and review SOPs, protocols, plans, and reports. Additionally, you will play a vital role in executing and maintaining GLP, GCP, Safety, and Quality systems within the department. Maintaining displays such as labels, SOPs, charts, etc., will also be part of your responsibilities. If you are an employee from the QC department looking for a new opportunity, you are encouraged to apply and contribute to the dynamic environment at PTC - MORAIYA.,