104 Mhra Jobs - Page 2

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",

Purpose: The Global Patient Safety (GPS) organization is responsible for delivering scientific, medical and pharmacovigilance expertise in support of Lilly s products in development as well as for marketed medicines and devices globally. The Clinical Surveillance Scientist leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders is an important capability for this role. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Signal Detection and Safety Data Evaluation Drive the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile and consult and collaborate with other safety personnel as appropriate. Develop and review label changes and labelling modifications in collaboration with teams, regulatory and legal. Apply effective communication skills to lead and facilitate safety team meetings for compounds in clinical development and marketed products Define data acquisition strategy, methodology, and approach for safety evaluations. Perform analysis of safety data and lead authoring of safety topic reports Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and other personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner. Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions Risk Assessment, Regulatory Inquiries, and Periodic Reporting Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs) Provide input to safety communications in the form of labeling, medical information inquiries, and healthcare professional (HCP) letters Promote and Advance the Field of Pharmacovigilance Responsible for effective communication and influence with internal Lilly customers (e.g. medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies) Accelerate the advancement of and contribute to the development and coaching of peers and less experienced employees Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity Effectively function and communicate as part of inclusive cross functional teams (e.g. GPS Medical physicians and scientists, Pharmacoepidemiologists, Research and Business Unit team members, other safety personnel) that foster trust, respect, and accountability Demonstrate and apply pharmacovigilance knowledge, including the role of the QPPV, to ensure compliance with local laws and regulations Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with local laws and regulations Minimum Qualification Requirements: Advanced medical related graduate degree, such as: pharmacy (PharmD), nursing with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner), PhD with 1-3 years experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs. OR 3-5 years of clinical experience or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience Other Information/Additional Preferences: Clinical knowledge of various disease states, drug effects, human physiology and pharmacology Experience within Global Patient Safety or demonstrated understanding of Pharmacovigilance is preferred Demonstrated ability to manage multiple deliverables simultaneously Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. . .

Education Graduation in Pharmacy Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Work Experience 3-6 years work experience in Fette compression machine

JOB DESCRIPTION Designation: Research Associate (9-I) or Senior Research Associate (9-II) Job Location: Bangalore Department: BBRC PD ARD - GMP About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240- a strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation. Job Purpose (1-2 Lines): Analytical Research and Development working on Analytical GMP testing (AGT), and Syngene BMS Laboratory (SBL) stability programs Key Responsibilities: Testing of samples (drug substance and drug product for release testing and stability) using chromatographic, dissolution, and wet analytical techniques under a GMP environment following cGMP practices Analysis of API clinical campaign samples manufactured in Syngene pilot plant Qualification or requalification of API reference standards. Performing instrument calibration and qualification Performing method validation, and method transfers Troubleshooting HPLC, dissolution apparatus and other analytical instruments in the lab Deliver analytical results within the established windows and as per applicable guidelines Compliance & implementation of quality systems Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Electronic lab notebook documentation Miscellaneous lab responsibilities Educational Qualifications: M.Sc. Chemistry for 9-I; M.Sc. Chemistry or M. Pharm for 9-II; Technical/Functional Skills: The candidate should have a good educational and theoretical, analytical chemistry background Good knowledge of analytical techniques The candidate should understand instrument calibration, qualification, method validation, and analytical testing Good understanding of documentation as per GxP requirements (electronic notebook) The candidate should have good proficiency in MS office tools Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, MHRA, etc. is preferred. Experience: 1-2 years with M.Sc. for 9-I ; 3-5 years with M.Sc. or 1-2 years with M. Pharm for 9-II Behavioral Skills: Strong commitment toward work and a high level of dedication, enthusiasm, and motivation Good speaking-listening-writing skills, attention to detail, proactive self-starter Ability to work successfully in a dynamic environment Should be able to work in a team and flexible for working in shifts. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Responsible for formulation and process development of oral immediate-release dosage forms, including oral film and tablet formulations. Troubleshoot and problem-solve unresolved or new formula issue

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th JULY 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

JOB RESPONSIBILITY : Accountabilities Scope of work Plant Accounting Manage day-to-day accounting activities at the manufacturing plant, including inventory, production costs, and expense tracking. Financial Statement & Audit Audit & Timely Review to be done timely. Timely compliance of ROC, Direct & Indirect Taxes to be done Finalization of audits related to overseas entity in coordination with Auditors. Projections and Product Costing Providing support to business for new products costing. New project feasibility Weekly projection New project evaluation though payback, IRR and other analysis report to management. Working Capital Management (AR controlling, Inventory monitoring) Review of AR on periodic basis to ensure timely settlement of receivable & keep books clean

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. ",

Job Description Hands on experience on injectable process equipment like Vial filling lines, PFS filling lines, Isolators, Lyophilizers, and Steam Sterilizers maintenance and ability to lead team of 5-10 members. Implementation and review of departmental documentation, validation & QMS activities. Shall have Hands-on experience on Change Control Management, Investigations & CAPA modules. Tracking allocated QMS task completion and closer within time. Analysis of breakdown notifications. Planning and execution of SAP preventive maintenance and timely closure. Maintaining and procurement of critical spare parts. Should be innovative, self-starter and work within the allocated budget. Focus on reverse engineering. Develop and coordinate with external vendors for and developing of indigenous spare parts and maintenance activities. Lead continuous improvement initiatives in the filling lines to increase process efficiency, energy conservation and capacity while maintaining a high level of quality. Ensure compliance to cGMP and quality system. Having exposure to face the regulatory auditors like USFDA, MHRA, ANVISA and TGA etc. Prepare the budget and capex for the engineering department and monitoring of yearly expenditure of engineering department. Ensuring compliance of safety policies, safe work environment for all the team members, external party, contractors etc. Legal compliance with respect to safety & environment, licensing with government authorities. Work Experience 8 to 10 years Education Diploma B. Tech in Electrical or Mechanical Engineering Competencies 1. Strategic Agility 5. Result Orientation

Experience Required: B.Pharm / M. Sc. with 2-4 years of experience in Chemical & Instrumental analysis QC (Finished goods & stability). Approved chemist licensed candidate shall be preferred. Well versed with CAPA, GMP Documentation, should have exposure to regulatory audits such as MHRA, USFDA etc. Followings will be the responsibilities of the position holder: 1. Analysis of Stability Samples/ Finished Products as per respective STP/Specification in Quality Control of Hormone block. 2. Calibration of routine usage instruments such as Balance, pH meter and Conductivity meter, as and when required. 3. Timely analysis of stability sample (Hormone block) and report if any abnormality observed. 4. Timely Charging & withdrawal of samples from Stability Chambers & their documentation within the time frame. 5. Sample reconciliation and destruction record of stability sample. 6. Implementation of GLP / GMP requirements. 7. Coordinating and aligning the practices and procedures in line with the COBC requirements 8. Stability sample charging, Withdrawal, Reconciliation and data entry in software such as LIMS. 9.Completion of assigned trainings of GLP/GMP on time 10. Reporting of stability/Finished product sample as per report received from outside Laboratory and check the compliance against respective specifications. 11.Evalutates the analysis results as per SOP and report to the supervisor for any abnormality. JOB FAMILY: Operations Quality t

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

Career Category Operations Job Description As an Associate, Regulatory Data Management you will help ensure the compliance of our regulatory data via the smooth compliant flow of information across our systems and processes. Roles & Responsibilities: Provide support on maintaining our Regulatory Information Management (RIM) system. Create and archive clinical trial, marketing application submissions and health Authority correspondence within the organisation RIM system. Serve as a point of contact between regulatory representatives, CMC, safety, partners and the submission management team. Provide support on creating, running and analysing reports for data streamline projects. Provide support within data management global team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Highly motivated, organised, and detailed oriented team player. Familiarity with regulatory procedures and filings. Familiarity with global clinical and regulatory health authorities requirements e. g. FDA, EMA, MHRA etc. Preferred Knowledge and Skills: Working knowledge of the Veeva Vault platform is preferred Basic Education and Experience: Master s degree and some directly related experience OR Bachelor s degree and 2 years of directly related experience OR Associate s degree and 4 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP .

: Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS) With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

: Job TitleBond Analytics Analyst, AVP LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader inCash Managemnet, Trade Finance & Lending, Securities services and Trust & Agency Service. Focusing on the treasurers and finance departments ofcorporate and commercial clients and financial institutionsacross the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS) With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 5 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Lead a team to drive excellence in investigation, compliance, and continuous improvement. • Continuously improve capabilities for manufacturing operations. • Prioritize timely investigation and operational improvement with a strong focus on results. • Identify root causes using the right investigation tools and implement effective CAPA (Corrective and Preventive Actions). • Work on procedural gaps to prevent deviations. • Develop a compliance mindset within the team. • Strengthen integrity and right-first-time culture within the team. • Identify improvement opportunities in processes and procedures, removing non-value-added steps. • Use operational excellence tools to identify and minimize all kinds of losses. • Coach colleagues on operational excellence tools and drive projects for capacity improvements. • Regularly update data in management information systems (MIS). • Analyze data available in the production system and take appropriate action. • Conduct TPM (Total Productive Maintenance) and continuous improvement meetings regularly. • Develop subject matter expertise for internal and external audits. • Identify compliance and operational discrepancies through regular Gemba walks. • Understand OEE (Overall Equipment Effectiveness), Lean, and Six Sigma methodologies.

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreements with external partners Risk assessments and periodic performance reviews of critical vendors Handling of audit observations and CAPA follow-up Supporting change control and deviation management related to vendors Qualifications B.Pharm / M.Pharm / M.Sc. in a relevant discipline 5-8 years of relevant experience in Quality Assurance, specifically in Vendor Management Sound knowledge of GMP regulations (USFDA, EU, MHRA, etc.) Experience in vendor audits and supplier qualification Strong documentation, communication, and interpersonal skills Proficiency in QMS tools and audit management systems

Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Clients Thoroughly and succinctly document the research and analysis related to the financial activity and related entities of Clients Escalate issues to client and internal managers to bring issues to their attention promptly Independently handle clients and client calls establish self as a valued partner Help knowledge management endeavor by sharing process knowledge and best practices within the teams Communicate effectively and efficiently with relevant internal and external parties to obtain KYC documents Have a thorough understanding of the clients business and related parties to monitor clients activities for unusual transactions Perform further investigation on identified suspicious client and clients transactions and report to KYC/AML compliance officer Qualification and Skills Bachelors Degree (B.Com, BBA, BBM, BCA) / Masters Degree (M.Com, MBA, PGDM). 2 to 4 years of experience and knowledge of KYC, AML, and Due Diligence Should be able to understand, manage and calculate risks Should be good with logical and quantitative abilities

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

The Senior Executive QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering change controls and deviation handling Risk assessment and mitigation using tools like FMEA and HAZOP Periodic review and requalification planning Participation in internal/external audits and regulatory inspections Ensuring data integrity and documentation compliance across qualification records Responsibilities Qualifications B.Tech / M.Tech / B.Pharm / M.Pharm / M.Sc. with specialization in Engineering, Life Sciences, or related field 5-8 years of relevant experience in QA Engineering or Qualification/Validation domain Strong knowledge of GMP regulations (USFDA, MHRA, EU) and qualification standards (ISPE, WHO, ICH Q9, Q10) Hands-on experience in equipment/facility qualification, HVAC, water systems, and cleanroom validations Excellent documentation review, risk assessment, and communication skills