175 Stability Studies Jobs - Page 4

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-formulation studies (API characterization and Drug-Excipients compatibility studies). 4. Operation and calibration of different analytical instruments. 5. Take into account existing QC facility while developing any product for successful method transfer. 6. Analytical method validation and method transfer activity. 7. Maintain the Good Laboratory practices, Good Documentation practice and Good hygiene practices. 8. Prepare for all type of internal and external audit/inspection. 2. Stability Studies of R&D Products 1. Responsible for stability studies of new R & D products for Regulated market projects. 2. Responsible for interpretation of stability data of the products related to analytical methods. 3. Observations of stability trend and discussion of same with formulation team. 4. Management of stability batches analysis and take the decision for stability studies of different batches as per requirement. 3. Routine Support to F&D Team 1. Responsible for providing routine support for the new product development for regulated market projects. 2. Planning and execution of routine batches analysis in minimum possible time. 3. Analytical data review and to provide the online results and observations to F&D Team. 4. GLP, GDP and Documentation Support 1. Responsible for maintaining the overall GLP and GDP in the Laboratory and providing overall GLP support during day to day activities. 2. Maintenance of working standards, Impurities and reference standards 3. Responsible for preparation, review and approvals of all the documents generating in the ARDL laboratory. 5. Team Building 1. Ensure continuous training and up-gradation of knowledge of the R&D team so that they are at the cutting edge of technology. 2. Set challenging goals for team members to ensure they deliver as per their true potential & as per the need of organization. 3. Identify & nurture the top talent of team. 4. Arrange a monthly interaction with team members to understand & resolve their performance bottle necks & also give them feedback for course correction. Performing any other responsibility as per the requirement, in the larger interest of organization. Interested!!!Please share your cv at Neetij@selectsourceintl.com Thanks & Regards

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 Transfer: Facilitating the successful transfer of analytical methods to quality control or production laboratories, ensuring reproducibility across different instruments and environments. Stability Studies: Implementing and managing API stability programs to monitor how products perform under various environmental conditions over time, ensuring continued compliance with quality standards. Regulatory and Quality Support: Providing analytical data and reports in support of regulatory filings and ongoing quality assurance requirements. Troubleshooting and Problem Solving: Using analytical expertise and state-of-the-art equipment to resolve issues, such as product failures or abnormal impurity profiles, quickly and accurately. Instrument Calibration and Maintenance: Ensuring analytical instruments are properly maintained and calibrated for reliable and reproducible results. Reference Standard Management: Handling selection, qualification, and maintenance of reference standards for ongoing quality control. Routine analysis work Qualifications & Skills: M.Sc. / M.Pharm / B.Tech/M.Tech in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline. 3–8 years of relevant experience in a pharmaceutical R&D or CRO environment. Hands-on expertise in analytical instruments (HPLC, GC, UV-Vis/IR etc.). Sound understanding of ICH, USP/EP, and regulatory requirements. Proficient in data analysis, interpretation, and documentation. Strong problem-solving and communication skills; ability to work in cross-functional teams.

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 to ICH and regulatory guidelines. You will be responsible for preparing and maintaining validation protocols, analytical reports, and ensuring compliance with Good Documentation Practices (GDP). Additionally, you will oversee method transfer to QC, provide training, and address any troubleshooting issues that may arise. Conducting stability studies, preparing data reports, and collaborating with cross-functional teams to support product development will also be part of your role. Furthermore, you will be expected to investigate and resolve analytical issues, including OOS, OOT, and deviations, and implement Corrective and Preventive Actions (CAPAs) as necessary. Maintaining up-to-date documentation and ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be integral to your responsibilities. You will also evaluate vendors and key starting materials (KSMs) and provide insights to management based on your findings. In terms of past experience, you should have a strong understanding of analytical chemistry principles and techniques, including HPLC, GC, Dissolution, and UV-Vis. Proven experience in method development, validation, and regulatory compliance is crucial for this role. Familiarity with global pharmaceutical regulations such as those from the FDA, EMA, WHO, and ICH guidelines is essential. You should also be skilled in handling regulatory submissions and documentation, possess excellent problem-solving abilities, and have experience mentoring R&D scientists. Familiarity with CAPA systems and good documentation practices will further strengthen your candidacy for this position.,

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). - Managing and implementing change control processes effectively. - Proficient in preparing and maintaining Site Master Files, Master Validation Plans, and Batch Manufacturing Records (BMRs). - Conducting stability studies, managing stability programs, and handling Out of Trend (OOT) and Out of Specification (OOS) results. - Establishing and maintaining standards according to current regulatory guidelines and Pharmacopeia revisions. - Evaluating deviations, managing change controls, and implementing corrective and preventive actions (CAPA). - Proficient in equipment qualification, process validation, cleaning validation, and method validation. - Overseeing the calibration of equipment and adhering to ICHQ7A guidelines and other regulatory standards. - Conducting trend analysis, providing feedback for continuous improvement, and implementing Quality Risk Management strategies. - Working towards continuous improvement of quality systems and efficiently managing Quality Control departments. - Handling ISO documentation procedures, including quality manuals, work instructions, checklists, and audits. - Managing sampling and testing of excipients, Essential Oils, and Aroma chemicals. - Strong skills in effective manpower handling and communication in English, both oral and written. This is a full-time position with benefits including Provident Fund. The work schedule is day shift, and the work location is in person.,

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 prior art, and establish proof of concept through experimentation. Collaboration with cross-functional teams including Manufacturing Science and Technology (MS&T), Quality Assurance (QA), Quality Control (QC), and production teams across different geographies will be crucial for technology transfer and timely execution of submission batches. Your role will also involve identifying challenges, bottlenecks in development, and providing mitigation proposals at various stages of product development. Furthermore, you will be responsible for problem-solving, prioritizing activities, conducting development trials, and ensuring alignment with established milestones. Clear communication with internal stakeholders, proactive identification of challenges or risks, and adherence to business unit Key Performance Indicators (KPIs) will be essential aspects of your role. On a day-to-day basis, you will work closely with the formulation development teams to achieve key milestones, conduct experiments following QbD principles, and prepare presentations at different stages of product development. Your tasks will include literature reviews, sourcing API and Excipients, conducting preformulation studies, executing development trials, interpreting analytical data, and preparing necessary documentation for regulatory submissions. To be successful in this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 1 year of experience or an M.Pharm in Pharmaceutical Sciences with a minimum of 3 years of experience from reputable universities. Prior experience in working with generic pharmaceuticals in regulated markets such as the US, EU, or Canada will be advantageous. Your commitment to personal accountability, effective work habits, continuous learning, and collaboration with internal teams will be instrumental in contributing to the success of our organization's mission to make good health more affordable and accessible globally.,

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 around strategies, search prior art, and experimentally establish the proof of concept. Help identify the challenges associated, bottle necks in development and suggest mitigation proposals during development at various stages. Co-ordinate with CFTs viz. MS&T, QA, QC and production at different geographies for technology transfer and timely execution of submission batch(es). Problem solving- identify problem statement, gather facts and to facilitate analysis formulation development, process issues. Priortize activities with leads for experimentation in lab. Participate in execution of development trials and during execution of submission batches and further during commercialization. Align day to day activities in line with established milestones, execution of batches at global TGO operation site. Clear comminications with internal stakeholders, for identfying challenges/risk areas which would hamper the timely delivery of products. Align with the BU KPIs and work with group leaders/ leadership teams for implementation of organizational initiatives. Assist the domain leader in business process evalaution and identifying improvement areas. Demonstrate personal accountability and effective work habits, viz. working productively & act responsibly, and learn from mistakes. How you ll spend your day Work on bench with the formulation development teams for the timely achievement of key milestones. Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE. Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data To conduct literature review, prior art experiment design of the product identified for development. Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering. Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic formphase transformation studies, selection of excipients and process as per strategy. Conducting and performing the development trial at bench level, problem identification & resolution. Review and interpretation of analytical data for further action plan. Responsible for execution of Pilot BE batches and interpretation of bio results. Responsible for execution of scale-up and exhibit batches at different manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results. Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE). Establish the stability data for development batches in collaboration with the analytical team. Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report. Co-ordination with various CFT S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product. Compilation and preparation of pharmaceutical development report with respect to current QbD format. Responsible for preparation of Product Developmental Report (PDR) for filling. Handling of deviations, change control and OOS related to Exhibit batches. Preparation, updation of SOPs. Maintaining of batch, calibration and other necessary records. Subjecting required batches to stability studies. Your experience and qualifications Ph. D. in Pharmaceutical Sciences with 1 Yrs +/ M. Pharm in Pharmaceutical Sciences with 3yrs+ from reputed universities Experience in working in a high performance teams in known generic space/ organisations with known generic footprint in regulated markets. Viz. US/EU/Canada Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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 in line with updated guidelines. Requesting, follow-up and tracking of Product Quality Review (PQRs) related data. Preparation and evaluation of Product Quality Review (PQRs) for externally supplied products, related coordination and follow-up with suppliers and other stakeholders. Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to Product Quality Review (PQRs). 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 CROs/CQC. Writing and/or reviewing of process validation, technology transfer, study batch documentation for own products. Write/check/review pharmaceutical documents as per regulatory requirements. Candidate having knowledge of theoretical and/or possible Physico-chemical risks for products based on appropriate available data (E.g., evaluation of synthesis route of API, excipients, packaging materials details etc.) will be an added advantage. Write documents into Orion s IT systems. Preparation and maintenance of lists/documents/records and archiving at appropriate place. Co-ordination with other departments / partners. Achievements of responsibilities within the agreed timelines. To assist the overall working of Indian Pharmaceutical team. Other possible tasks appointed by Supervisors. Note: We do not have own laboratories in India! Primary Skills (essential) Minimum 4 years experience in Formulation R&D or API R&D activities in global Pharma industry Knowledge of organic chemistry/ Pharmaceutical medicinal chemistry/ synthetic chemistry will be an added advantage Ability to analyze the impact of change on Nitrosamine and/or other relevant physico-chemical risks assessment, if possible. Confirmed knowledge of EU requirements and ICH guidelines Candidate having interest and/or experience in pharmaceuticals documentation or any relevant pharmaceutical formulation / manufacturing related documentation will be preferred. Practical development skills from the laboratory to the production scale concerning different types of formulations (tablets, capsules, liquids, etc.) will be considered as an added advantage. Fluency in oral and written English Task oriented with learning attitude and Teamwork skills Confirmed skills of Microsoft Office are essential This job offers An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group Possibility to utilize your own strengths with the support of professionals Flexible, high spirit working environment where your skills are appreciated Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Bachelors/masters degree in pharmacy from a reputed College/University or Masters degree in chemistry from a reputed College/University At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life. Please visit our website to find further information about our values and Orion as an employer https: / / www.orion.fi / en / careers / orion-as-an-employer / . How to apply and additional information Please fill Candidate Information Form on https: / / forms.gle / o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 31.07.2025

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 stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

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 US. You will be responsible for preparing and reviewing literature search reports for drug substances and products, proposing formulation strategies, guiding executives for development batches in the lab, providing expert input into formulation and process studies, and ensuring compliance with specifications. Additionally, you will evaluate vendors for packaging material, monitor stability studies, prepare Technology Transfer documents, coordinate with stakeholders, and adhere to GLP and GMP. Qualifications and Skills required for this role include an M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field with specialization in drug delivery systems or formulation science preferred. You should have 8-10 years of hands-on experience in formulation development, with at least 5 years focused on nasal spray or inhalation formulations. Technical expertise in nasal spray formulation techniques, drug-excipient interactions, device development, particle size distribution, viscosity, and droplet characteristics is essential. You should possess strong project management skills, experience in working with cross-functional teams, and knowledge of regulatory requirements for nasal spray formulations. Leadership qualities, excellent communication and presentation skills, problem-solving abilities, and a knack for innovation are crucial for this role. The work environment will primarily be based at the R&D center, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,

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 chemistry background and analytical instruments.

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, temperature excursions, stability data, process validation documents and troubleshooting etc. for externally supplied products. Write documents into Orion s IT systems for example analytical methods Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to PQRs. Requesting, follow-up and tracking of PQR related data. Review of Externally supplied PQRs, related coordination and follow up with vendor and and other stakeholders Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials Co-operation with other departments/ partners Local in-licensing support To assist the overall working of Indian Pharmaceutical team Other possible tasks appointed by Supervisors Note: We do not have own laboratories in India! Primary Skills (essential) Minimum 4 years work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry Knowledge of EU and US requirements and ICH guidelines Practical development skills from the laboratory work and troubleshooting Task oriented with learning attitude and Teamwork skills Fluency in oral and written English Confirmed skills of Microsoft Office is essential Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets, capsules, liquids, etc.) will have added advantage Candidate interested/experienced in above documentation work will be preferred. This job offers: An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group Possibility to utilize your own strengths with the support of the professionals Flexible, high spirit working environment where your skills are appreciated Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Masters degree in chemistry from a reputed College / University. At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life. Please visit our website to find further information about our values and Orion as an employer https: / / www.orion.fi / en / careers / orion-as-an-employer / . How to apply and additional information Please fill Candidate Information Form on https: / / forms.gle / o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 18.07.2025

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, Kalyanpur (Vill), Baddi, Solan, H.P, INDIA 173205 CONTACT INFO: E-mail: Harishwar.M@hetero.com & Contact: 8121005416 for further info NEED TO CARRY: Resume, 3 Month Pay slips, Increment letter, Previous company relieving letters, Education Documents and ID Proofs

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 product integrity, consumer safety, and regulatory compliance. Key Responsibilities Perform microbiological testing of raw materials, in-process samples, water systems, packaging, and finished goods. Conduct environmental monitoring of cleanrooms and production areas (air, surface, and personnel hygiene). Validate disinfectants, preservative efficacy, and microbial limits as per pharmacopeial standards (IP/BP/USP). Maintain and calibrate laboratory equipment and ensure proper documentation (SOPs, logbooks, test records). Support product stability studies, contamination investigations, and root cause analysis. Coordinate with QA and R&D for batch release, deviation handling, and process improvements. Ensure adherence to GMP, ISO, and regulatory compliance for cosmetic and oral care formulations. Qualifications & Skills Education / Certifications: B.Sc / M.Sc in Microbiology, Biotechnology, or Life Sciences Hard Skills: Expertise in microbial testing techniques (TPC, Yeast & Mold, Pathogens) Hands-on experience with colony counters, autoclaves, incubators, and laminar airflow Familiarity with preservative efficacy testing (PET), D-value & Z-value analysis Knowledge of regulatory guidelines BIS, FDA, ISO, and cosmetic-specific standards Soft Skills: Detail-oriented and accurate in documentation and reporting Strong analytical and problem-solving skills Team player with good communication across departments Ability to handle audits and provide scientific justifications Preferred Experience: 3+ years of hands-on experience in microbiology testing within a cosmetics, pharma, or personal care manufacturing setup Why Join Us? Be part of a growing and future-focused company where your scientific contributions directly shape the quality and safety of consumer products. We offer a collaborative and innovation-driven work culture, aligned with global best practices in personal care manufacturing. Apply Now WhatsApp Apply Now WhatsApp Job Location : Bavla On Call Assistance: HCP HR Talent Acquisition +91 7600217962 +91 9998962424 Email hr@hcpwellness.in career@hcpwellness.in info@hcpwellness.in Job Type: Full-time Perks: Team Outings Cafeteria Soft Skill Training Job Training Health Insurance Office cab/shuttle

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 Drug Substance, Drug Product & In process Materials related to Peptides. Responsible to prepare Study Protocol and Study Reports. Responsible for analysis of Oligonucleotides (DNA & RNA molecules) of single strand (Sense and Antisense) and Duplexes molecules. Responsible for Development of IEX and Ion Pair method for Sense and Antisense to separate charge variants in DNA and RNA molecules Responsible for Development of SEC method to separate size variants in DNA and RNA molecules. Responsible for Isolation of Peptide molecules from impurities by PREP HPLC.

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 ensure successful implementation. Troubleshoot analytical methods and resolve technical issues. Sample Analysis & Testing: Conduct routine analysis of raw materials, intermediates, and finished pharmaceutical products. Perform quantitative and qualitative analysis following established protocols and regulatory guidelines. Execute stability studies and analyze samples at designated time points. Instrumentation & Maintenance: Operate and maintain analytical instruments including HPLC, GC, GC-MS, FTIR, UV-Vis spectrophotometers. Perform routine calibration. Troubleshoot instrument issues and coordinate with service technicians when needed. Ensure proper documentation of instrument performance and maintenance activities. Data Management & Reporting: Analyze and interpret analytical data using statistical methods and software. Prepare technical reports, certificates of analysis, and regulatory submissions. Maintain accurate laboratory records and electronic data systems. Knowledge & Experience Master's degree in Analytical Chemistry, Chemistry, or related field. 2 - 4 years of relevant experience in pharmaceutical, chemical, or analytical laboratory settings. Strong foundation in analytical chemistry principles and techniques. Preferred Qualifications Experience with advanced analytical techniques (DSC, TGA). Previous experience in pharmaceutical or biotech industry. Understanding of stability testing and forced degradation studies. Knowledge of cleaning validation by UV / HPLC. Why Join MPDRPL? Be part of an organization driving cost-effective global healthcare solutions . Work on end-to-end projects from concept to market. Collaborate with experts across departments in a quality-driven, innovation-centric environment . Access to modern formulation laboratories and pilot-scale facilities. Competitive compensation with performance-linked incentives . Professional development and career advancement opportunities . Comprehensive employee benefits including healthcare and retirement plans .

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-equivalent products. Provides support and guidance in scale up/Technology transfer activities for new Formulation development Projects Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.,) Guiding the F&D teammates to timely complete the development activities. Review and summarizing technical data for milestone assessments. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality. Responsible for review of analytical data (e.g. dissolution, assay, related substances, Blend uniformity, content uniformity etc.) Supporting regulatory team in health regulatory submission and query response. Maintain Evolet Healthcare Policy on Quality, Safety and Efficacy Value.

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 stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file. Responsible to follow safety precaution as per laboratory procedure. Responsible to escalate any issue / incident to reporting manager for prompt corrective action. Responsible for method development studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for method Validation studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for routine and stability studies of API, Drug Product & In process Material preferably Peptide molecules Responsible to perform the pharmacopeial evaluation study as per requirement. Responsible to align with organization goal. Other responsibilities assigned by reporting authority. Responsible to follow Quality Management Document procedure. Responsible to perform the calibration of instrument. Responsible to prepare Study Protocol and Study Reports. Responsible to maintain instrument/equipment as per SOPs. Responsible for timely archival of documents as per SOP. Responsible to follow safety precaution as per laboratory procedure. Responsible to ensure proper Handling and Disposal of waste. Responsible to qualification reference standard / working standard/chemical reference standard samples as per approved and valid procedure.

Job Summary: We re looking for an experienced and detail-oriented professional to manage and oversee all QC lab activities. This role demands strong leadership, in-depth technical knowledge, and a commitment to regulatory excellence. The selected candidate will support the HOD, lead lab teams, and drive compliance with GMP, ISO, and global quality standards. Key Responsibilities: Supervise daily QC lab operations and testing activities Act as HOD designee during their absence Ensure timely testing and release of RM, intermediates, and finished products Investigate and document deviations, OOS, OOT, and lab incidents Implement and maintain QMS in alignment with cGMP, ISO, FSSC, Halal & Kosher Review and update specifications and pharmacopeial methods Oversee validation and revalidation of analytical methods Train analysts on lab techniques, SOPs, GLP & GDP Monitor stability studies and ensure protocol adherence Manage instrument calibration, qualification, and maintenance Review analytical reports, calibration records, and lab documentation Lead/support internal and external audits Coordinate with Regulatory Affairs and QA teams Implement pharmacopeia updates and support regulatory readiness Contribute to continuous improvement and special quality initiatives Qualification : MSc Chemistry Experience : 4-8 Years