253 Stability Studies Jobs - Page 7

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, I...

: Review of R&D developmental data of ARD and PD like Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, Study Reports, for accuracy, data integrity and compliance to systems, procedures and regulatory requirements. Review of Technology Transfer documents like Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications and MOAs. Conducting routine laboratory rounds for ensuring compliance to Good Laboratory Practices. Handling of Change Controls, Deviations, Incidents and Laboratory Assessment Reports. Preparation, review of SOPs and conducting the SOP Training. Conductin...

GLA University is seeking applications for two full-time Assistant Professors of Pharmaceutical Chemistry for the Institute of Pharmaceutical Research at GLA University, Mathura campus. As an Assistant Professor, you will be responsible for academic instruction, research supervision, and actively participating in departmental development. We are looking for individuals with a strong academic background, research potential, and a passion for shaping the future of pharmaceutical education. The role of Assistant Professor in Pharmaceutical Chemistry is based at GLA University, Mathura (U.P.), and is a full-time, regular position. To be eligible for this role, you must hold a B. Pharm and M. Pha...

Hiring - ADL (AMD) - Nagpur Location Location - Nagpur MH Company - Pharma (MNC) Core OSD Formulation + Method Validation Experience Msc or Mpharm /bpharma Responsibility - Sr. Role Description 1. Analytical Method Development New analytical method development and troubleshooting of existing method of different types of Oral solids dosage form (Granules, Tablets, Pellets, Capsules etc.) for Regulated market projects or as per business need. 1. Ensure robust & cost effective method development of product by considering the available facility & resources 2. Conduct Literature survey, different pharmacopoeia & pharmacopeia forum search and review & application of same in AMD. 3. Conduct Pre-for...

Job Title: Scientist / Sr. Scientist API R&D Department: Research & Development Location: Kolkata Key Responsibilities: Analytical Method Development: Develop and validate robust analytical methods (HPLC, GC, LC-MS, UV, FTIR, etc.) for quantification, purity, stability, and impurity profiling of APIs (maintaining GLP) Method Validation and Verification: Conducting studies to confirm that the developed methods are suitable for their intended purpose, meeting parameters like specificity, accuracy, precision, linearity, and ruggedness, Prepare and review technical documentation, including method development reports, validation protocols/reports, and regulatory submission documents. Method Trans...

As an Assistant Manager or Team Leader at Synnat Pharma in Visakhapatnam, you will play a crucial role in leading method development, validation, stability studies, and technology transfer activities. Your meticulous nature and extensive experience will be essential in collaborating closely with R&D, QC, and Regulatory teams to support product development and ensure compliance with global pharmaceutical standards. You should possess strong analytical expertise, leadership skills, and a dedication to regulatory compliance and continuous improvement. Your responsibilities will include developing, optimizing, and validating analytical methods such as HPLC, GC, UV-Vis, and Dissolution according ...

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, you will be responsible for running the department independently. Your role will require strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Mana...

As a bench scientist in our organization, you will be responsible for conducting experimentation and research in the area of formulation development, process development, regulatory affairs, and intellectual property for global markets. Your work will involve planning and executing experiments aligned with project milestones while applying scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be expected to analyze and interpret data from literature reviews effectively to support decision-making processes. Additionally, you will need to understand the intellectual property landscape, develop strategies, search for pr...

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Who we are The opportunity Bench scientist with good analytical acumen in the area of formulation research and development, process development, Regulatory and Intellectual property for global markets. Planning and conducting of experimentation in line with project milestones. Should have worked on products at different stages from selection to launch with scientific principles of QbD, DoE, statistics and scaleup principles. Ability to comprehend facts and data from literature reviewed and present the information effectively for decision making. Understand IP scenario and work on various design ar...

Role & responsibilities : 1) Having from OSD background. 2) Responsible for analysis of RM/IP/FG/Stability on HPLC. 3) Responsible for Calibration of HPLC 4)Having the Knowledge of the Pharmacopeia.IP/BP/Ph.Eur/USP Skill Required: 1) Handling of the HPLC, 2) Calibration Management. 3)Knowledge of the GLP Environment 4) Handling of the HPLC, 5) Calibration Management. 6)Working Standard, Ref. Standard, Imp Standard, Primary Standard Management Additional Remark: Required candidates background should be in Regulatory environments

Roles and Responsibilities To perform product lifecycle management tasks for externally supplied products and own production products like evaluation of change controls, deviations, temperature excursions, stability data, process validation documents from Product quality point of view. Handling of problem-solving cases for products (includes both analytical and formulation related changes which have impact on product quality). Overall product quality evaluation and provide input during suppliers meetings. Follow up with suppliers and/or other stakeholders for documents related to changes for externally supplied products. E.g., possible impurities in API and finished products risk assessment ...

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for s...

Location - Manufacturing Unit, Bommasandra Qualification - MSc - Chemistry Experience - 2- 5 yrs Role : Analyst LCMS/HRMS Key Job responsibilities: Analyst should able to carryout testing in method transfer and method verification activities. Subject matter expert on analysis of HPLC, LCMS, GCMS for both assay and impurities routine samples of in process, cleaning validation, SFG & Stability. Subject matter expert in analysis of nitrosamine impurities. Subject matter expert calibration of instrument and its management.

The Manager - Nasal Spray Formulation Development will lead the development of innovative nasal spray formulations, driving projects from concept to commercial scale-up. You will focus on the design, development, and optimization of nasal spray drug products, ensuring regulatory compliance and meeting quality standards. Leading a team of formulation scientists, you will collaborate with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Key responsibilities include having relevant experience in developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and...

Role & responsibilities Preferred candidate profile Perks and benefits

QC Chemist

Method Development & Method Validation on HPLC. Stability Studies. Method transfer. Core API Experience. API R&D Preferred Immediate Joiner. Experience- 3-5 Yrs Required Candidate profile Good Experienced with Analytical Method Development & Validation on HPLC. Stability Studies Samples. Calibration.Good Knowledge of Analytical Technics. API R&D.

Select with space bar to view the full contents of the job information. Research Associate - Analytical Development Job Details | Himalaya Wellness Company By continuing to use and navigate this website, you are agreeing to the use of cookies. Accept Close Search by Keyword Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Research Associate - Analytical Development Himalaya Wellness Company Literature survey and implementation of analytical technique Knowledge of Method development (HPLC, GC) and validation of botanical markers Knowledge on stability studies and method validations for APIs and Finished product Should have strong natural chemistr...

Roles and Responsibilities Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and commenting on change controls, deviations, tempe...

WORK LOCATION: Baddi, Himachal Pradesh DEPARTMENTS AND EXPERIENCE: QC Quality Control Experience: (01-10 Years) •HPLC/ IP/ FP/ RM/ Validation/ Stability/ GC ARD - OSD Experience: (02-05 Years) •HPLC/ FG/Analytical Method validation/ Stability/liquid chromatographic PRODUCTION Experience: (01-06Years) •Compression, Granulation, Coating, PACKING Experience: (02-06Years) •Blister Packing, Bottle Packing(ELMACH-3522), Bulk Packing (IMA-PG) QUALIFICATION : ITI, Diploma, B.Sc, B.Com, M.Sc, B.Tech, B. Pharm, M.Pharm with relevant experience DESIGNATIONS: Operator, Jr. Officer, Officer, Jr.Executive, Executive & Sr.Executive INTERVIEW VENUE: Hetero Labs Limited (Formulation Unit). Chakkan Road, Kaly...

About HCP Wellness At HCP Wellness Private Limited , we are committed to delivering safe, effective, and high-quality skin care, cosmetic, and oral care products. Our culture thrives on scientific excellence, GMP compliance, and sustainable innovation. We believe in empowering our team to lead quality-focused solutions that help build trusted personal care brands. Job Overview We are looking for a Microbiologist to join our Quality & R&D division in Ahmedabad. The ideal candidate will be responsible for ensuring microbiological safety and compliance of all raw materials, bulk, and finished goods used in cosmetic and personal care product manufacturing. Your insights will directly impact prod...

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to align with organization goal and other responsibilities assigned by reporting authority. Responsible to perform the calibration of instrument and to maintain instrument/equipment as per SOPs. Responsible to follow safety precaution as per laboratory procedure. Responsible for method development studies of Drug Substance, Drug Product & In process Materials related to Peptides. Responsible for method Validation studies of Drug Substance, Drug Product & In process Materials related to Peptides. Responsible for analysis of routine samples and stability studies of Drug Product & In process Material Dr...

Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years

About Us Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs. Job Roles & Responsibilities Analytical Method Development & Validation: Develop and optimize analytical methods for pharmaceutical compounds using HPLC, GC, UV-Vis, and other analytical techniques. Perform method validation studies including accuracy, precision, linearity, specificity, and robustness testing. Transfer analytical methods between laboratories and...

Job Description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. To handle a team of 10 to 15 team members. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equi...