86 Stability Studies Jobs - Page 3

* For Quality Control (IPPT/FP, RM/PM):- To perform all test for in process product & finish product as per the specification and schedule. To investigate failure of FP / Out of specifications (OOS) and take the corrective and preventive actions (CAPA). To perform and ensure the calibration of instruments as per the schedule. To perform and ensure preparation of reagent / volumetric solution as per schedule. To perform and ensure observation of FP retained samples. To ensure that all documents related to the testing data and related papers are maintained properly. To implement Corrective and Preventive Action (CAPA). To carry out the sampling of all the materials according to Standard Operating Procedure (SOP). To carry out the testing of Raw Material and Packing Material according to approved procedure. To release Raw Material and Packing Material. To carry out the calibration of instruments as per the schedule. To prepare the working standards as per the guidelines and various pharmacopoeias. To ensure the status tag on the released material and transfer such material in the released area. To follow the Good Laboratory practices and Good Manufacturing practices (GMP). To prepare requirement list of chemical & reagent for procurement. To perform the analysis of stability sample as per current specification. To compile the data required for internal quality audit in the plant, as and when required. * For Quality Control (Stability):- To implement the change in procedure as per change control note. To check and verify the sampling of respective samples as per defined intervals for testing. To check and verify that the samples are kept at appropriate temperature and humidity as per defined procedure, which is as per the Standard Operating Procedure. To verify results of analysis conducted in respective period, and to carry out trend analysis. To coordinate with Purchase department for routine requirement and follow up for the procurement. To sign the documents related to stability studies data. To select product batches for the stability studies. In the absence of Officer, Executive will ensure his roles and responsibilities. In the absence of Executive, Sub-department Manager will ensure these roles and responsibilities. To file deviation in case of non-compliance * For Quality Control (Micro):- To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines. To do sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water and pure steam. To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, chlorides, hardness, silt density index and other testing as per the requirements. To analyze the samples of water system after maintenance work . To observe and record the results the microbiological plates and test tubes after analysis as well as supervise discarding method of same. To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material sample as per the requirements and SOPs and record the results for the same. Candidate Profile:- Ready to work in Rotational shifts. Excellent understanding about working area. Initiator and Learner. Decision making ability. Team player and if required, can provide training to other team members. Good communication. The above mentioned requirement is for Male Candidate Only. Hence can be ready to work in rotational Shift. Candidate having Parenteral /Injectable exposure would be preferable . Candidates having Pharma exposure will only be considered for interview process. Fresher can also email their CV on Anee.Silas@otsukapharma.in

Job Purpose (Why Job Exists?) Jr. Cosmetic Formulator Key Result Area Ensuring timely development of innovative and client-specific formulations for skin care range Stay up to date with trending ingredients, active technologies, and market trends in skincare, and personal care. Supervise formulation trials, stability studies, and efficacy testing to ensure product performance and regulatory compliance. Coordinate with clients and the sales team to understand project briefs and convert them into viable, scalable formulations. Ensure accurate documentation including formulation records, product dossiers, trial reports, and compliance paperwork. Work closely with QA/QC, Production, and Packaging teams for smooth handover of formulations for scale-up. Handle cost optimization without compromising product efficacy and quality. Lead innovation projects and explore opportunities in cosmetics, clean beauty, and sustainable formulations. Competencies Domain Knowledge (R & D Processes & Experiments) Knowledge about analytical instruments & technologies Authorities Reporting Sr. Cosmetic Scientist Experience & Relevant Industries Other Education Master of Engineering/Tech in Other or Other Bachelor of Engineering/Tech in Other or Other

Role & responsibilities Position Summary: As an Analytical Scientist at Off Targets Research, you will play a crucial role in the development and validation of analytical methods for the characterization of pharmaceutical products. You will work closely with cross-functional teams to support the research, development, and manufacturing processes by providing accurate and reliable analytical data. Key Responsibilities: Develop, validate, and optimize analytical methods for the analysis of pharmaceutical compounds using techniques such as HPLC, GC, and spectroscopy. Perform routine and non-routine analysis of raw materials, intermediates, and final products to ensure compliance with regulatory standards. Collaborate with R&D, Quality Control, and Manufacturing teams to troubleshoot and resolve analytical challenges. Prepare and review technical reports, method validation protocols, and standard operating procedures (SOPs). Maintain and calibrate analytical instruments, ensuring they are in proper working order. Interpret and present analytical data to support decision-making processes. Stay current with industry trends and advancements in analytical techniques. Preferred candidate profile Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. A Ph.D. is preferred. Proven experience in analytical method development and validation, preferably in the pharmaceutical or biotechnology industry. Proficiency in using analytical instruments such as HPLC, GC, LC-MS, and spectroscopy. Strong understanding of regulatory requirements (e.g., FDA, ICH guidelines) related to analytical methods. Excellent problem-solving skills and attention to detail. Ability to work independently and as part of a team in a fast-paced environment. Strong written and verbal communication skills. Perks and benefits Opportunity to work on innovative research projects that contribute to groundbreaking therapies. Collaborative and inclusive work environment that values professional growth and development. Competitive salary and benefits package. A chance to make a real impact in the field of pharmaceutical research. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

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

Roles and Responsibilities Coordinate and follow-up with internal and external partner to review and evaluate Nitrosamine impurity and ensuring compliance to relevant guidelines. Managing and developing the process for Excipient GMP risk evaluation including maintenance of the structure with functionalities. Review elemental impurities statement, its impact on final product and ensuring compliance. 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 Required documents: CV/Resume Application deadline: 05.07.2025

Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times. Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, Particulate matter analysis using Malvern, PAMAS, HIAC and other relevant instrumentation techniques. etc. Role Accountabilities: Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers, Particulate matter analysis techniques. Shall have experience on Good documentation/laboratory practices such as ALCOA+. Experience in calibration and qualification of various analytical instruments HPLC, UPLC, GC, and other QC laboratory instruments Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control). Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards / Chemicals / Reagents / Consumables / Spares etc., required for the projects Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Must possess good communication and e-mail etiquettes. Behavioural Skills Good Interpersonal skills Self-time management Good team player Good communication skills Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 0-6 years Skills and Capabilities: Hands-on HPLC, UPLC/UHPLC, CG, UV-visible spectrophotometer, Potentiometer, Particulate matter analysis techniques and QC other analytical instruments Theoretical knowledge in Chromatography and spectroscopy technique Good documentation/laboratory practices such as ALCOA+. Able to follow work instructions and perform the tasks under the supervision of the Team leader Preparation and Maintenance of all the documents Good knowledge of MS-office (word, excel, ppt) Education M. Pharm/ M. Tech/ M.Sc. / B.Tech., B.Sc. (Analytical chemistry/Chemistry)

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

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 QbD paradigm , using OFATs and DOE. 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 experimentaly establish the proof of concept. Help identify the challenges assocaited, bottle necks in development and suggest mitigation proposals during development at various stages. Co-ordinate with CFTs viz. MST, 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. Successful demonstration of proof of concept and ensure prospective documentation in line with QbD paradigm. Discuss and deliberate needful measures for timely execution of batches and ensure regulatory filing, approval and launch of generic drug products. Your experience and qualifications Ph. D. in Pharmaceutical Sciences with 3 Yrs +/ M. Pharm in Pharmaceutical Sciences with 6 to 10 years 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.

Stedman Pharmaceuticals is looking for a dynamic and experienced candidate for the Quality Control (QC) department with hands-on experience in Analytical Method Validation for various dosage forms. Resume to hrd@stedmanpharma.com / 9786920463

Dear All, We are conducting Walk-In Interview on 13th June 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: AQA - 6-8 Years of experience in Analytical QA IPQA - 2-4 Years of experience in Line Clearance activities for Production, Warehouse and Dispensing of Raw Materials Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, HPLC and Dissolution instruments Microbiology - 2-3 Years of experience in Environmental monitoring, Culture media preparation and MLT testing Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100

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

Roles and Responsibilities Develop formulations for solid oral dosage forms (tablets) and liquid orals. Conduct formulation research development, stability studies, and analysis to ensure product quality. Prepare trial batches of formulations and document them accurately. Collaborate with cross-functional teams to resolve formulation-related issues. Ensure compliance with regulatory requirements during all stages of formulation development.

Role & responsibilities Analytical data review of in-process, Batch release and stability samples & planning of activities in the Instrumentation lab Trouble shooting of HPLC & UPLC instruments, maintaining of lab as per GLP GDP practices. Audit trail verification of APLE & UPLC 1. Preparation, revision and review of SOPs, STPs, Specifications and GTPs and Worksheets related to product testing. 2. Preparation, revision and review of analytical method Validation protocols and reports related to product testing. 3. Responsible for shift schedules and test planning activities. 4. Testing, documentation, review and release of In-process, Batch release, Stability and Miscellaneous samples. 5. Responsible for testing review and release of product samples by analytical techniques like CZE, HPLC, UPLC etc., 6. Responsible for handling of OOS, OOT, Incidents, LIRs, Change controls and Risk Assessments. 7. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 8. Responsible for training of QC analysts and new joiners related to product testing. 9. Review of analytical reports and work sheets related to product testing 10. Maintenance of all QC documents related to product testing. 11. Preparation and Review of reagents and buffers. 12. Responsible for GLP compliance. 13. Responsible for usage, monitoring and verification of all kinds of Laboratory log books 14. Responsible Sample management and Material management in Quality Control. 15. Stability Management. 16. Responsible for calibrations, validations and PMP of instruments related to product testing. 17. Preparation, execution and review of reference standard qualification. 18. Responsible for procurement and verification of reference standards stock and consumption records 19. Responsible for conducting internal audit of other departments as part of GMP compliance. 20. Responsible for general cleanliness of laboratory 21. Responsible for coordinating with IT department for ensuring the electronic data backup, data retrieval of instruments related to product testing. 22. Responsible for preparation for URS. 23. Responsible for Coordinating with inter and intra departments for technical discussions. 24. Responsible for samples sending and checking of outside laboratory reports. 25. Responsible for preparation and uploading of job responsibilities for new joinee or whenever employee job role change. 26. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 27. Any other responsibilities assigned by reporting officer and HOD. Preferred candidate profile

Work Experience 1-5 years Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i.e.: Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Education Masters in Life Science Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Analysis of Stability and Finished products and maintain GDP and GLP . Follow compliance of current regulations and etc. Testing of Finished Products maintain all GLP document and calibration of Instrument like HPLC, UV spectrometer etc. HPLC, Stability and Working standard section incharge. And also involved in Documentation related activity. Incident, OOS, OOT and CCF initiations and investigation report throug LIR with trackwise. Qc trainings and supporting to RA.

Urgent Opening for QC Chemist Knowledge of HPLC, GC, Stability , KF, UV, validation, Documentation etc

Job Title: Management Associate MPD – AMA Contract Resource Department: MPD-BB, AMA PHC Location: Andheri East Chakala, Mumbai Position Type: Full-Time, Contractual Vacancies: 1 Job Description: We are seeking a Management Associate to support the MPD – AMA team on a contractual basis. This role involves key responsibilities in pharmaceutical documentation, data management, and coordination to ensure efficient support to formulation and analytical development teams. Key Responsibilities: Setup of Enovia DSM for formulation parts and documentation. Compilation and tracking of stability study data for review and approval in Enovia. Raise and manage Change Controls in Veeva QA system for MPD department (CCPs in scope). Maintain status trackers for ongoing/pending CCPs and ensure timely closure and action item follow-ups. Support the MPD Process and Analytical teams with preparation of batch records and other regulatory documentation. Create Coupa Purchase Orders (POs) based on verified quotations. Perform QC Soft entries for reports on stability data, raw material samples, and protocol documentation. Coordinate with the MPD lab team for: Disposal of laboratory waste. Dispatching samples for external testing with accurate documentation. Updating records for destruction of leftover stability samples. Assist in TT document and supplier qualification reviews . Liaise with RM suppliers for collection and review of material qualification and safety documents . Perform additional tasks as assigned by the MPD team. Qualifications: B. Pharm / M. Pharm from a recognized institution. Experience: Minimum 2 years of relevant experience in Formulation Development (F&D) and Technology Transfer functions in a reputed pharmaceutical company. Key Skills: Familiarity with Veeva QA, Enovia DSM, QC Soft, and Coupa Strong knowledge of pharmaceutical documentation and stability study processes Experience in Change Control and Regulatory Compliance Good communication and coordination skills Proficient with MS Teams, SharePoint, and Email correspondence

Engineer-power system studies Think bigger scale. Think higher profile. Think ground-breaking. Join WSP, and you ll be at the heart of a team of international experts all dedicated to growing and sharing their expertise, and working on projects that transform society for all of us. WSP are looking for Principal Engineer - Power System Studies with over ten years experience of overall responsibility of strong engineering design, installation, configuration testing and commissioning, co-ordination including site supervision of works with emphasis on meeting the contract requirements with respect to quality, time and budget. The key objectives of the roles are to: Power system analysis of transmission and distribution projects. Feasibility studies, masterplans, despatch studies, renewable integration, grid code reviews Preparation of Renewable generation connection schemes from distribution to utility scale generation including determining techno-economical optimum amount of renewable generation. Load flow study, fault level calculations, harmonic analysis, voltage stability and transient stability analysis on transmission, distribution, and industrial power systems, using DIgSILENT, PSS/E, PLEXOS, ETAP, CYME PSAF, ASPEN OneLiner, ASPEN database and IPSA+. Review all the Power System Studies technical submittals by EPC contractor / Developers in reference to Client s Electricity Transmission Code and International standards as applicable. Review the Power system models developed by EPC contractor specific to each study. Attend all the required meetings & address all the technical clarifications raised by EPC contractor / Developer. Attend the FAT & SAT visits to ensure all the performance criteria are met related to grid compliance requirements. The test shall be conducted with RTDS or other similar tools. Review the updated model received from EPC based on FAT/SAT reports and ensure all the grid compliance requirements are met as agreed during the detail design stage. Assist Client to incorporate HVDC model provided by EPC contractor into the TRANSCO network PSSE & PSCAD models suitable for various planning studies (steady state and dynamics). The power system studies review work shall briefly include, but not limited to the following: Reactive power capability study Grid impact study Transient and dynamic stability studies Insulation co-ordination study Switching transient study Faulted transient switching study Transformer Energization study AC/DC harmonics and flicker study AC/DC harmonic filter sizing report Harmonic impedance locus identification and analysis study AC protection relay setting coordination study Sub-synchronous resonance studies All required ETC compliance studies Wed love to hear from you if you have: Master s Degree in Electrical / Power systems Engineering. Minimum 10 years of working experience with similar capacity. Proficient with Power system study softwares like PSS Sincal, PSSE, PLS CAD, Dig silent etc. Must have experience in Power System Studies and design related to High Voltage Direct Current (HVDC) offshore projects, Specifically Voltage Source Converter technologies, Grid Impact studies, etc. Must have experience in Power system studies on Transmission and Distribution projects. Essentially having detailed knowledge related to review of contractor s drawings. People managing skill, with excellent written and verbal skills. Able to build excellent client relations through communication and multidisciplinary coordination skills Plexos Energy modelling What if we can? What if we can have work-life balance? What if we can be rewarded in ways that support our individual needs? What if we can be accepted for who we are? Here at WSP - we can! WSP recognizes that work is only one part of our lives and making time for the other things in our life is important - be that our families, our friends or ourselves. So, if working from home, working part-time or having flexible start and finish time will help with this let us know as part of your application. As well as rewarding you with competitive pay, WSP offers standard benefits including first class medical cover, paid professional subscriptions. Be you, be happy - we strive to have a friendly and inclusive culture which respects and maximizes the contribution individuals can bring to WSP. We recognise the benefits that people with varying backgrounds and experiences can bring. Here at WSP we positively encourage applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, religion or belief, marital status, pregnancy or maternity/paternity. We will interview all disabled applicants who meet the essential criteria.

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and pharmaceutical products using techniques such as HPLC, GC, and method validation. Perform stability studies to ensure compliance with GMP guidelines. Calibrate instruments accurately and maintain records of instrument maintenance schedules. Ensure accurate documentation of test results, reports, and certificates of analysis. Collaborate with cross-functional teams to resolve quality issues. Only male candidates

Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring

? Job Description: ? ? We are looking for a skilled and proactive QA/QC professional with 2 5 years of experience to join our quality team. The candidate will be responsible for executing and overseeing quality assurance and quality control activities in compliance with regulatory and company standards. ? ? Key Responsibilities: ? ? Quality Control? ? Perform analytical testing of raw materials, in-process samples, and finished products. ? ? Operate, calibrate, and troubleshoot instruments such as HPLC, UV-Vis, GC, FTIR, and KF. ? ? Prepare and review analytical documentation including test reports, COAs, and calibration records. ? ? Guide and Mentor QC Executives / Trainees for analytical testing ? Quality Assurance? ? Review batch manufacturing and packaging records (BMR/BPR). ? ? Investigate and document deviations, OOS, OOT, and implement CAPA with timely closure. ? ? Review and manage controlled documents (SOPs, protocols, forms) issuance, retrieval, and archival. ? ? Perform internal audits; support regulatory audits (e. g. , WHO, ISO, etc. ). ? ? Oversee GMP, GLP, hygiene training for production and QA/QC staff. ? ? Coordinate stability studies, analyze trends, and maintain stability protocols and logs. ? ? Ensure data integrity in documentation and electronic systems. ? ? Participate in risk assessment and mitigation for quality events. ? ? Support technology transfer, scale-up, and cross-functional quality activities. ? ? Evaluate and audit vendors and suppliers as part of QA oversight. ? ? Requirements: ? ? 2 5 years of hands-on experience in analytical techniques and instruments in a regulated environment. ? ? Strong understanding of cGMP, GLP, and ICH regulatory requirements. ? ? Proficient in analytical instrumentation and documentation practices. ? ? Ability to handle audits, deviations, and quality systems independently. ? ? Excellent communication, collaboration and organizational skills. ? ? Team player with attention to detail and accuracy. ?

Role & responsibilities Independently design, plan and execute moderate to complex analytical method development experiments. Analyze the data, communicate results to clients and write technical protocols and reports Prepare method protocols, & technical reports for characterization of analytical methods based on separation techniques (HPLC, UPLC, GC), Spectro-analytical technique (Ultraviolet-Visible Spectrophotometry) and dissolution testing. Experience in developing pharmaceutical small molecules analytical chemistry methods for dissolution muti-media screening and analyzing data using compendial methods. Exposure in stability testing as per ICH guidelines. Preferred candidate profile Experience in drug product analytical development within a commercial organization. Good knowledge of three main pharmacopoeias (Japanese;, JP, US; USP and European Ph. Eur,) and ICH guidelines related to method development and validation Excellent communication (oral and written), attention to detail, effective problem solving and decision-making skills Ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude. Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Oversee and execute analytical testing of raw materials, in-process samples, and finished products. Ensure compliance with cGMP, GLP, and regulatory guidelines. Review and approve analytical data, test results, and documentation. Troubleshoot analytical instruments like HPLC, GC, UV, and FTIR. Support method validation, stability studies, and regulatory audits. Implement quality improvement initiatives and ensure data integrity

Method development & Validation ( HPLC /GC/ UV/ Potentiometer etc..) for both Solid orals and Injectables & Handling of all analytical instruments/ Equipments, SOPs prepation, SPEC and STPs prepation/ review,Stability samples analysis .

For day to day sample extractions & instrument (LCMS/MS - GCMS/MS) sequencing Roles and Responsibilities Testing of various agriculture and food products for chemical and nutritional testing by standard and in-house methods Hands on expireance in Proximate Analysis Operating the lab instruments like pH meter, weighing balance, incubator, GCMS/MS & LCMS/MS, UPLC Preparation of standard solutions Daily maintenance of lab equipment. Following good laboratory practices Following disposal process for samples & solutions as per SOP. Accurate analysis and interpretation of test results Maintenance of laboratory documents and records Validation of methods and calibration/verification of instruments Ensuring purity and validity of CRMs Conduct sensory evaluations of food samples