41 Qbd Jobs

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

3+ years of hands-on CMC experience required with JMP for statistical analysis, including DoE(Design of experiment), statistical approaches: PCA, and PLS. Strong understanding of QbD, PQR, and regulatory guidelines (ICH/FDA) required. Proficiency in SAS/R programming is essential Software: Minitab and JMP

Key Responsibilities: Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional team towards to meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualification M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years Additional Information

Role & responsibilities 1. Literature Search, Pharmacopoeia and Patent Search, Review and Discussion and Documentation. 2. Application of NOC, Test License, Manufacturing and Import License 3. Reference product Characterization, Manufacturing and Import License. 4. Reference product Characterization, Reverse Engineering and prototype development. 5. Preformulation study, Manufacturing of bench scale trials for formulation development. 6. Manufacturing of process optimization batches, scale up batches and submission batches. 7. Preparation of Bill of Material, Master Formula Record for manufacturing of submission batches. 8. Preparation of Product development Report for regulatory filing of products. 9. Should have knowledge on product development requirements for Regulated market (EU/UK/Canada). 10. Should have knowledge on QbD and DOE, formulation development and Process development of drug products. 11. Coordination with CFTs like: DQA, Clinicals, Regulatory, Technology transfer and production for smooth development and transfer of product from laboratory to Production floor. 12. Knowledge on IR/MR solid oral drug products. Preferred candidate profile Male candidate only

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 - 8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

Role & responsibilities 1. Responsible to lead a team of 4-5 scientist for the development of drug products of Regulated Market (EU and UK) 2. Responsible for drug product development to exhibit batch execution and to support for regulatory filing. 3. Conduct Literature survey and compile the scientific data per product. Development of Rubust, bioequivalent formulation and processes through optimization by applying QbD principles. 4. Compilation and review of developmental data and exhibit batch stability data. 5. Should have good understanding on Reference Product Characterization, reverse Engineering, Bioequivalent Prototype development, Stability studies, Scale up activities. 6. Coordination with different cross functional team like ADL, IP, Project Management, SCM, Clinical and regulatory for smooth execution of the projects. 7. Execution of Tech Transfer and monitoring scale up / Exhibit batches. 8. Having well verse knowledge on Regulatory Guidelines for EU, Canada and TGA 9. Lab activities and team management experience is must. Preferred candidate profile Team Management, Formulation Development, Scale Up and Technology Transfer

Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.

1+ years in US Bookkeeping Work from office - Ahmedabad, Gujarat 3 PM to 12 AM - Mon to Fri Quickbooks Online / Desktop mandatory Fluency in English mandatory Immediate joiner preffered Share updated CV at glory.m@crystalvoxx.com / 75670 60888

Job Summary We are seeking a dynamic and experienced Formulation Scientist in Topical division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. Roles & Responsibilities You will be responsible for end to end Formulation development of Topical formulations (Creams, Ointment, Gels, Sprays and Foams) including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD). You will be responsible to support in scale-up to pilot/plant scales for topicals. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technologytransfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization,processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documentsfor drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materialsand ensure development studies are performed related to regulatory and internal system requirements. you will be responsible on preparation of assessments for impurities including Nitrosamine impurities and should be well versed with guidelines of India market, Russia market and US market requirements. Qualification Educational qualification: Masters in Pharmaceutical Technology/Pharmaceutics Minimum work experience: Approx. 5 years of experience in pharmaceutical company topical products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in Topical dosage forms Experience in areas of product development for Generic topical dosage forms Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Job Description: NDDS (Novel Drug Delivery System) Scientist - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements. Formulation Development: Design and develop NDDS formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products. Perform pre-formulation studies, including solubility, stability, and compatibility evaluations. Technology Integration: Implement innovative drug delivery technologies, such as microencapsulation, nano-particle systems, and multi-layer tablets. Optimize drug release profiles to enhance therapeutic efficacy and patient compliance. Process Development: Develop scalable and robust manufacturing processes for oral solid dosage forms. Perform critical parameter optimization for processes like granulation, blending, compression, and coating. Analytical and Stability Studies: Collaborate with the analytical team to develop and validate testing methods for NDDS products. Conduct stability studies in compliance with ICH guidelines. Regulatory Compliance and Documentation: Prepare technical reports, protocols, and batch manufacturing records. Ensure compliance with cGMP, ICH, and FDA guidelines during formulation and process development. Technology Transfer: Oversee the transfer of lab-scale formulations to pilot-scale and commercial manufacturing. Work closely with production, quality assurance, and regulatory teams to ensure seamless transfer. Innovation and Research: Stay updated with emerging trends in NDDS and oral solid dosage technologies. Contribute to patent applications and publications to support organizational innovation initiatives. Key Requirements: M. Pharm / M.S. in Pharmaceutics or related field. 4 to 7 years of relevant experience in formulation development of OSD for USFDA or other regulated markets. Strong knowledge of QbD, scale-up and technology transfer. Experience in developing formulations for bioequivalence studies and regulatory submissions. Familiarity with USFDA/EMEA regulatory guidelines and documentation. Excellent problem-solving, documentation, and communication skills. Preferred Skills: Hands-on experience with granulation, compression, coating, and capsule filling equipment. Ability to work cross-functionally in a fast-paced, deadline-driven environment.

Role & responsibilities Experience: 9-14 years Specialization: 14 years of experience in Peptides Key Responsibilities: 1 Design and develop formulations for peptide-based drugs, ensuring stability, efficacy, and optimal bioavailability. 2. Conduct research on novel excipients and innovative drug delivery mechanisms tailored for peptide formulations. 3. Lead scale-up and technology transfer of peptide formulations from lab-scale development to commercial production. 4. Coordinate with analytical teams to perform in-depth characterization studies, including stability profiling and compatibility assessments. 5. Ensure regulatory compliance in formulation strategies, preparing CMC documentation for global regulatory submissions. 6. Optimize formulation processes using QbD and DoE approaches to enhance efficiency and quality. 7. Collaborate with manufacturing and production teams to ensure seamless formulation execution at large-scale levels. 8. Conduct pharmacokinetic and bioavailability studies to refine peptide drug delivery strategies. 9. Lead troubleshooting efforts related to formulation challenges, ensuring robust and scalable peptide drug development. 10. Provide technical leadership, mentoring junior scientists, and fostering innovation in peptide drug formulation. Qualifications: Extensive experience in peptide formulation and drug delivery systems. Expertise in stability studies, compatibility assessments, and formulation troubleshooting. Strong understanding of peptide pharmacokinetics, bioavailability enhancement, and absorption mechanisms. Experience with process development, scale-up, and technology transfer for peptide-based formulations. Knowledge of regulatory pathways, GMP compliance, and preparation of CMC documentation. Ability to develop innovative formulation strategies for improved therapeutic performance of peptide drugs. Proficiency in QbD and DoE methodologies to optimize formulation development processes. Preferred candidate profile Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.

Regional Head – Operations Job type : Full time Reporting Manager : India Operations Director / Account Director No of staff managed : 200 Job profile Qualification Bachelor’s Degree / Master Degree Industry Type FM Services, Hotels, Projects, Overall Experience : 12 -14 years Industry Experience 10-12 years of relevant / equivalent experience Technical Skills Building Services Generic Skills Leadership, Communication, Vendor/people management, Strategies Behaviors Team work, Learning attitude, Innovation mindset Job Aim: To take complete ownership for all client deliverables for all the facilities in the city. The person will be responsible to provide comprehensive facility management services, as per the contractual terms with a focus on continuous improvement for the respective facilities. Will also be responsible to achieve financial and other Key Performance Indicators ( KPIs) established by the Client. The Regional Head must be a team player and work with other functions within JLL and also the client stakeholders to achieve outcomes. Competencies Interpersonal skills with a strong client focus. Team Leader with line management skills and the ability to delegate Client /Supplier relationship management Technical comprehension and experience with performance based service contracts and vendor management Knowledge of occupational safety requirements Strong budget management and financial analysis skills Excellent written and oral communication skills. Strong analytical skills. Responsibilities Operations delivery Overall service delivery of the region KPI / Compliance Scores and management Manage escalations with closure in a timely manner People Management Ensure right expectation setting for the team, ability to maximise performance of the team. Training for the team Growth Plan for the team Employee assessment, identify shortcomings and plan development Technology Ensure optimum utilization of all technology tools that are implemented from time to time. Innovation/ Initiative Keep a track and updates on Energy savings project for the region. Focus / Thrust on improvements/ initiatives Financial Acumen Keep a track one Office services / R&M /Capex Budgets /work closure Understanding of the facility / City spend Track FM Operational Expenses CRM / SRM Client/employee engagement, Leadership connects Service partner’s engagement Vendor management Vendor engagement /Identification and evaluation on larger aspects Expansion/Go live Overall planning / Cost proposal & approval Approval/transition/Go live Ensure/oversee closure on project snag BCP /Risk management Oversee, assess risk, plan and handle any BCP situation. Certification/Internal Audit Ensure/oversee preparation end to end for all audits Business Reviews Responsible for Quarterly Business Reviews Publish timely and relevant reports for client and senior management Location On-site –Bengaluru, KA Scheduled Weekly Hours: 40 If this job description resonates with you, we encourage you to apply even if you don’t meet all of the requirements. We’re interested in getting to know you and what you bring to the table! JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL’s recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. Candidate Privacy Statement . For candidates in the United States, please see a full copy of our Equal Employment Opportunity and Affirmative Action policy here. Jones Lang LaSalle (“JLL”) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process – including the online application and/or overall selection process – you may contact us at Accommodation Requests . This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page I want to work for JLL.

Role & responsibilities Experience: 9-14 years Specialization: Oral Solid Dosage Key Responsibilities: 1. Develop and optimize formulations for OSD drug products. 2. Conduct pre-formulation studies, compatibility assessments, and stability testing. 3. Lead formulation development for OSD products, including tablets, capsules, and granules. 4. Design and optimize OSD formulations, ensuring stability and efficacy. 5. Work closely with manufacturing teams for scale-up and technology transfer of OSD formulations. 6. Ensure compliance with regulatory guidelines and GMP standards. 7. Innovate in OSD drug delivery systems and formulation strategies. 8. Develop regulatory-compliant documentation for submission. Qualifications: PhD/Masters in Pharmaceutical Sciences. Significant experience formulation development and OSD technologies. Strong understanding of regulatory requirements for OSD products. Proficiency in QbD , DoE , and process optimization. Preferred candidate profile 1. Experience of compliance with regulatory guidelines and GMP standard 2. Hands on experience of Pre -formulation studies , compatibility Assessment , stability Testing

Role & responsibilities Experience: 9-14 years Specialization: Oral Solid Dosage with at least 4 years of experience in Peptides Key Responsibilities: 1. Lead formulation development for OSD products, including tablets, capsules, and granules. 2. Develop and optimize stable peptide formulations for OSD applications. 3. Conduct pre-formulation studies, compatibility assessments, and stability testing for peptide-based formulations. 4. Innovate in drug delivery strategies, ensuring enhanced bioavailability and release kinetics for peptide-based OSD formulations. 5. Work closely with analytical teams to characterize formulations using advanced techniques. 6. Oversee scale-up activities, ensuring successful transition from laboratory to pilot and commercial-scale production. 7. Manage technology transfer processes across manufacturing sites to ensure formulation integrity and reproducibility. 8. Prepare and review regulatory documentation, including CMC sections for global submissions. 9. Ensure compliance with GMP standards and regulatory guidelines for peptide drug formulation. 10. Utilize QbD and DoE principles for formulation optimization and process development. 11. Provide scientific leadership and mentorship to junior scientists within the formulation team. Qualifications: PhD/Masters in Pharmaceutical Sciences, or industrial Pharmacy Extensive experience in peptide formulation and oral solid dosage technologies. Strong expertise in excipient selection, stability enhancement, and formulation optimization. Understanding of global regulatory requirements, including expertise in preparing regulatory submissions and ensuring compliance with CMC guidelines. Ability to drive innovation in peptide formulation strategies and drug delivery systems. Preferred candidate profile OSD Experience at least 4 years of experience in peptides Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.

MS Dynamics prefer, and generic Testing skills CRM will be good to have Ensure successful test case execution maintaining the organizations quality standards Maintain work allocation and reporting structure Maintain document repository of all test results and project level changes Maintain workplace discipline and adhere to organization standards Provide status updates on daily, weekly, monthly basis to test manager and Project Manager

Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualification Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Role & responsibilities Process Characterization and Optimization : Quality by Design(QbD) approach and execute experiments for process characterization, including identifying critical process parameters (CPPs) that meets Product CQAs. Deep understanding on Cell culture and Purification Process with knowing Design space concepts, range studies and process fitment studies to achieve QTPP ranges. Thorough knowledge on designing process with knowledge on material attributes and process parameters for attaining Quality. Sound Knowledge on process characterization, use of PAT tools and statistical software for OFAT and multivariant study designs. Develop and optimize upstream and downstream purification processes for biosimilar products. Perform risk assessments and define process control strategies to ensure product consistency and compliance with regulatory standards. Data Analysis and Reporting : Analyze experimental data to establish process parameters and justify the design space. Develop comprehensive characterization reports and present findings to cross-functional teams. Use statistical tools for data analysis, process capability assessments, and troubleshooting. Regulatory Compliance and Documentation : Prepare detailed technical reports, batch records, and documentation for regulatory submissions. Participate in regulatory inspections, audits, and responses by presenting scientific rationale and documentation on process characterization. Drafting of CMC Dossier sections for Process characterisation for biosimilar products Cross-functional Collaboration : Collaborate with process development, analytical, and MSAT teams to ensure end-to-end process robustness. Contribute to project meetings, provide scientific input, and communicate project status, risks, and mitigation strategies to stakeholders. Preferred candidate profile Education : Masters or Ph.D. in Biochemical Engineering, Biotechnology, Biochemistry, or a related field. Experience : Minimum of 10 years in upstream/downstream process development or characterization in biopharma, with a focus on biosimilar or biologics. Technical Skills : Proficiency in cell culture techniques, including bioreactor operation, media development, and cell line maintenance Expertise in protein purification methods (chromatography, filtration, etc.). Experience in design of experiments (DoE), statistical analysis, and process modelling. Familiarity with regulatory guidelines (e.g., ICH Q8/Q9/Q10, FDA, EMA) and cGMP. Proficiency in data analysis software (e.g., JMP, Minitab, or similar). Soft Skills : Strong analytical skills, attention to detail, excellent communication and presentation abilities, and the capacity to work collaboratively across teams.

Job ID/Reference Code INFSYS-NAUKRI-210549 Work Experience 3-5 Job Title Payments - GPP Responsibilities Global Pay Plus - Payments Technical and Professional Requirements: PaymentsISO-20022 standards SWIFT, SEPA, MT messages Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering * Location of posting is subject to business requirements

Job Description At Accenture, we believe your career is about what you want to be and who you want to be. It's about bringing your skills, your curiosity and your best true self to your work. Here, you'll match your ingenuity with the latest technology to do incredible things. Together, we can create positive, long-lasting change. We are: Strategy & Consulting Global Network at Accenture empowers our people to compete, win and grow. We develop everything they need to grow their client portfolios, optimize their deals and enable their sales talent, all driven by sales intelligence. Topic Advisory at Accenture. Our Topic Advisory team is a specialty sales advisory service within the Strategy & Consulting Global Network. We are specialists aligned to Accenture's priority business offerings with expertise in how to go-to-market and best position Accenture to win work. We are the sales lab that works with offering leadership, equipping them with relevant market insights, customized sales messages, and curated sales assets to originate, sell, and win. You are: An experienced Consultant who has profound sales and delivery expertise in Sustainability Particularly you have deep expertise in at least one or more of the following 3 areas: Sustainability Strategy development, ESG regulations / regulatory reporting, ESG governance & operating model design ESG risk assessment / measurement, ESG data management and understanding of underlying platform technologies Supply Chain Scope 3 decarbonization, Sustainable Procurement practices, Circular Business Models Well versed with what it takes to win consulting work, allowing you to build trust and effectively partner with Accenture stakeholders to sell our sustainability services to clients The work: As a Topic Advisory Consultant, you will provide sales support within our global Sustainability Services network. This will include but is not limited to the following: Support go-to-market campaigns Prepare and elevate materials (e.g. Proposals, Stage 0, Analysis, Research, etc.) Bring the latest knowledge and best of content to each opportunity (e.g., industry trends benchmarking, competitive insights, etc.) inclusive of leveraging subject matter expert network Help shape solutions for our clients (approach, team, pricing, differentiators, etc.) to best fit the deal requirements Develop go-to-market assets Conduct reviews with client teams to identify areas of improvement and harvest deliverables Stay relevant through training, research, client interaction and feedback sessions The work does not require travel. Qualifications Here is what you need: Bachelors degree in business or engineering 4-6 years of experience in Sustainability A minimum of 3 years in sales or consulting at a top-tier consulting firm Structured thinking with a quantitative mindset Strong oral and written communication skills (clarity, consistency, conciseness) Proficient use of PowerPoint English language fluency (oral and written) Confidence working under time pressure and in fast-paced environments Must support/mirror working hours for the supported Market Unit or other business area Must be flexible with working hours to meet shifting business needs Must have good internet connectivity and distraction-free environment for working at home, in accordance with local guidelines

Job Description At Accenture, we believe your career is about what you want to be and who you want to be. It's about bringing your skills, your curiosity and your best true self to your work. Here, you'll match your ingenuity with the latest technology to do incredible things. Together, we can create positive, long-lasting change. We are: Strategy & Consulting Global Network at Accenture empowers our people to compete, win and grow. We develop everything they need to grow their client portfolios, optimize their deals and enable their sales talent, all driven by sales intelligence. Topic Advisory at Accenture. Our Topic Advisory team is a specialty sales advisory service within the Strategy & Consulting Global Network. We are specialists aligned to Accenture's priority business offerings with expertise in how to go-to-market and best position Accenture to win work. We are the sales lab that works with offering leadership, equipping them with relevant market insights, customized sales messages, and curated sales assets to originate, sell, and win. You are: An experienced Consultant who has profound sales and delivery expertise in Sustainability Particularly you have deep expertise in at least one or more of the following 3 areas: Sustainability Strategy development, ESG regulations / regulatory reporting, ESG governance & operating model design ESG risk assessment / measurement, ESG data management and understanding of underlying platform technologies Supply Chain Scope 3 decarbonization, Sustainable Procurement practices, Circular Business Models Well versed with what it takes to win consulting work, allowing you to build trust and effectively partner with Accenture stakeholders to sell our sustainability services to clients The work: As a Topic Advisory Consultant, you will provide sales support within our global Sustainability Services network. This will include but is not limited to the following: Support go-to-market campaigns Prepare and elevate materials (e.g. Proposals, Stage 0, Analysis, Research, etc.) Bring the latest knowledge and best of content to each opportunity (e.g., industry trends benchmarking, competitive insights, etc.) inclusive of leveraging subject matter expert network Help shape solutions for our clients (approach, team, pricing, differentiators, etc.) to best fit the deal requirements Develop go-to-market assets Conduct reviews with client teams to identify areas of improvement and harvest deliverables Stay relevant through training, research, client interaction and feedback sessions The work does not require travel. Qualifications Here is what you need: Bachelors degree in business or engineering 4-6 years of experience in Sustainability A minimum of 3 years in sales or consulting at a top-tier consulting firm Structured thinking with a quantitative mindset Strong oral and written communication skills (clarity, consistency, conciseness) Proficient use of PowerPoint English language fluency (oral and written) Confidence working under time pressure and in fast-paced environments Must support/mirror working hours for the supported Market Unit or other business area Must be flexible with working hours to meet shifting business needs Must have good internet connectivity and distraction-free environment for working at home, in accordance with local guidelines

JOB DESCRIPTION 1) ARD Scientist (Analytical Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: ARD Sr Scientist/Jr Scientist capable in developing and validating analytical methods and Validation including calibration to ensure the quality and stability of pharmaceutical products. Key Responsibilities: Develop and validate analytical methods for drug substances and drug products. Perform analytical testing such as HPLC, GC, and wet analysis. Interpret analytical data to assess product quality, purity, and stability. Implement GLP & GDP practices. Prepare technical reports and documentation for regulatory submissions. Collaborate with the FRD & DQA to support product development. Troubleshoot analytical method issues and recommend improvements. Qualifications: Masters degree or Ph.D. in instrumental analysis, Analytical Chemistry, or related discipline. Expertise in analytical techniques such as HPLC, GC, and spectroscopy. Strong knowledge of regulatory guidelines such as ICH and FDA. Good documentation and report-writing skills. Problem-solving and analytical thinking abilities. Minimum 3(or) More Years for Junior scientist of experience in ARD /Q.C . For Sr Scientist 8 (or) more years of experience is desired 2) FRD Scientist (Formulation Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: FRD Sr Scientist/Jr Scientist is responsible for the research and development of pharmaceutical formulations, ensuring the products are safe, stable, and effective for consumption. Key Responsibilities: Design, develop, and optimize formulations for pharmaceutical or nutraceuticals Etc. Implementation of QbD . Conduct experiments to test product stability, and efficacy. Prepare technical documents, including formulation protocols and reports. Collaborate with cross-functional teams such ARD, DQA Etc to ensure compliance. Troubleshoot formulation issues and propose solutions. Qualifications: Masters degree in pharmaceutics or Ph.D. in Pharmaceutics & Equivalence, Minimum 3(or) More Years for Junior scientist of experience in FRD /R&D . For Sr Scientist 8 (or) more years of experience is desired Strong understanding of Good Manufacturing Practices (cGMP). Problem-solving skills and GDP implementation Skills in usage of software for developing of formulation and characterization. Excellent communication skills to present findings and collaborate with teams. Exposure in developing Liquid Orals, Solid Orals, Semi-Solid Orals. Nano formulations will be preferred 3) DQA Team (Development Quality Assurance Sr. Executive) Positions Sr Executive -1 Jr Executive -1 job Description: DQA Sr. Executive should monitor the quality assurance processes during product development, ensuring that all stages comply with quality standards and regulatory requirements and product specification need as per ICH Guidelines. Key Responsibilities: Lead quality assurance activities for product development, including design, testing, and validation stages. Ensure compliance with regulatory guidelines and quality standards (e.g., FDA, EMA, GMP). Develop and implement quality control procedures for new product development. Conduct internal audits and prepare quality assurance reports. Collaborate with R&D, ARD to implement the quality issues. Manage risk assessment processes and ensure continuous improvement in quality systems. Should have knowledge in QbD system for product development. Qualifications: Minimum experience should be 6-8 Years for sr executive and 1 to 3 years for junior executive in DQA (or) Q.A Bachelors or Masters degree in Quality Assurance /Analysis/Pharmaceutics, In-depth knowledge of cGMP, GDP, GLP, ICH and regulatory requirements and implementation. Excellent communication and problem-solving skills.

Responsibilities : Experience and the ability to communicate with US CPA firm and end client. Ability to review monthly and yearly bookkeeping/ accounting projects. Experienced into month end and year end closing. Excellent knowledge about bank and account reconciliation. Ability to prepare financial statements yearly and monthly basis. Min of 2-3 years of people management experience. Experienced in 940, 941 and 1099. Qualification & Experience: B.Com (Mandatory)/M.Com/BFA/Professional courses (preferrable) 5-8 years US accounting experience. Strong Technical, Interpersonal and Communication skills. US payroll Knowledge Advance knowledge of QBD, QBO, Xero and advance excel Shift Time 03:30 PM IST- 12:30 AM IST (Indian Summers) 4:30 PM IST-01:30 AM IST (Indian Winters) Skills and Attributes: Strong people skills are a must, as the majority of the work is client facing. Ability to analyses various information before making a conclusion. Possess character traits of resiliency and grit along with exceptional critical thinking and problem-solving competencies. A self-driven and result orientated individual able to work with minimum supervision. Excellent business writing skills. Be able to effectively support all aspects of engagement delivery end to end. Ability to communicate proactively and clearly in a highly responsive manner.

If you are looking for the right opportunity to start your career in the pharmaceutical industry, this is the perfect chance to begin your professional journey We are offering a yearlong Apprenticeship to Freshers for the below Departments and Qualifications. Manufacturing - B. Pharma/ M. Pharm Warehouse - B. com Microbiology - M.Sc. Microbiology Engineering & Projects - B.E or B. Tech Mechanical Packaging Device Development - B. Pharm/ M. Pharm/ M.Sc. (Chemistry) Work Location - Bilekhahalli, Opp. IIM Bangalore, Bangalore *Requirements to Apply* This opportunity is specifically for Freshers with the above-mentioned qualifications only Only candidates who have completed the course and have their Final marksheet/Provisional certificate/Degree certificate will be considered In case of any prior experience, the candidate should not have been covered under the ESI (Employee State Insurance) or PF (Provident Fund) If you are eligible and are interested to apply, You can share your CV/Resume to *Applying to this opportunity does not guarantee permanent employment. *The Hiring Team (TA, Hiring manager or HR) reserve rights to not consider/ reject any misfit candidate.

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 -8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. . 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

Purpose of the role: Drug Product MSAT and Technology Transfer TECHNICAL COMPETENCIES: 1. To ensure Site / Tech -transfer of products to Manufacturing site. 2. To ensure Process Performance Qualifications Role Purpose: 1. Technology transfer of in house R&D developed products. 2. Product transfers from internal and external sites to CDMO. 3. Ensure the compliance of Relevant SOPs in product transfer process. KEY DUTIES AND RESPONSIBILITIES: 1. To involve in execution of feasibility/exhibit/pre-validation/process qualification batches for 2. Technology transfer of products and site transfer products. 3. To conduct trials required to generate additional information or knowledge to support the site transfer projects. 4. Responsible to follow EHS compliance as per the site EHS policy and manual. 5. Responsible for review and approval of process performance qualification and continuous 6. process verification protocols and reports. 7. Supporting the operations team for closure of deviations by involving in investigations for commercial batches. 8. Responsible for MFR review. 9. Responsible for preparation of BMP / Trial report. 10. Responsible for Gap analysis preparation. 11. Responsible to ensure product execution checklist for new products. 12. Preparation and review of protocols or batch records for trial batch on need basis.