104 Mhra Jobs

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 Education Graduation in Pharmacy Work Experience 3-6 years of experience in Fette compression machine

MISSION: The Case Specialist s job is to guarantee the optimised management of vigilance cases, using their scientific knowledge to enable a detailed analysis of the various files. He/she is the guarantor of the proper handling of a case, both from a regulatory and medical point of view, and in this respect masters the regulations in force. He/she must be able to validate all tasks related to the exploitation of cases, from their collection to their submission. In addition, he/she contributes to the smooth running of his/her Line Of Business. Main activities and technical skills: VIGILANCE CASES: Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields: Coding according to applicable dictionary (MedDRA/IMDRF/Product/WHO or other). Seriousness of the events/effects/incidents . Expectedness/listedness. Data entry of vigilance cases in ad hoc databases or in formats defined with the client. Follow-up request of vigilance cases by phone/mail Suggesting queries to complete the case. Confirm or support Data Officers submission requirements. Validation of documents within the Safety and Vigilance platform. Analysis of inclusion/exclusion for cases received from EV or MHRA ICSR download. Reconciliation activities. MEDICAL INFORMATION: In support of the medical information line of Business Taking phone calls reporting vigilance notifications. CUSTOMER/PROCESS MONITORING: Participation in the operational implementation of new clients. Key contact with clients (with the support of a senior member of staff or the division manager). Drafting/updating of technical agreements /safety management plan / client template (for a trial for example) Drafting/updating of procedures/ operating methods or others directly related to its activity Participation in the implementation/ maintenance/ improvement of processes Additional Activities: Participation in the coordination of Case Management by relaying to the coordinator if necessary. Support for the coordination of activities (including planning and monitoring) ensuring effective communication to the coordination team regarding cases received with short timelines to meet regulatory deadlines. Required Education: BPharm / MPharm Required Experience: 4-5 years Required Technical Skills: Well versed with MS Office, Safety Databasea Additional Skills & Experience: Presentation skills, Communication Skills, Should be well versed with pharmacovigilance basics, case processing and associated conventions, thorough knowledge of GVP modules, ICH guidelines, regulatory requirements, MedDRA coding, well versed with safety databases, solution oriented.

" 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 ",

Urgent opening for Head QA with rich experience in MHRA site. Job location Chandigarh

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for Calibration, Thermal Mapping, SOPs and Formats preparation, Training co-ordination, online documentation and other Engineering GMP activities as needed or requested by the organization. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Deputy Manager Engineering and Maintenance at ARPL for day to day engineering activities of allotted Job responsibilities. Execute in co-ordination with the user departments for calibration instruments related issues / problems and ensuring completion of calibration work orders. Execute / supervise with the help of contractor s on daily basis or as and when required for follow up and completion of calibration and other engineering cGMP documentation activities and projects. Execute / supervise the engineering department online documentation all time with respect to Risk Assessment preparation and approval / Calibration / Thermal Mapping/ Training / Logbooks. Planning of calibration and thermal mapping activities as per the schedule. Execute calibration of different type of instruments like Electrical, Electronics, Mechanical devices. Prepare Performance Qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS department personnel. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values. Execute / supervise the engineering department online documentation all time with respect to Equipment / Instruments Calibration, Thermal Mapping & Qualification activities. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory and compliance and safety requirements. Notification creation, Confirmation, and TECO updation for calibration and thermal mapping work orders in SAP PM module. Follow up with cross functional team for on time closure of CAPA, CCR, deviations with respect equipment qualification. All other duties as assigned. Job Requirements Education Graduates or B.Tech Engineering / Preferable in Instrumentation / Electronics and communication /B.Pharma Knowledge, Skills and Abilities Should have Knowledge in Calibration, Thermal Mapping and its related documentation. Should have good interpersonal and communicational skills. Should have hands on experience in SAP, MS Office etc. Strives to drive projects related to engineering systems effectively. Knowledge on ISPE (Internation society for Pharmacetiucal Engg - Good Engg Practices), ISO and WHO Should have exposure to any of the regulatory audits like USFDA, HC, MHRA, TGA, etc ., Experience Minimum 02 Year of experience for Bachelors degree or 04 Years of experience for Diploma in Engineering in a pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

" 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 ",

" 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 Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Reporting to (Business) Zonal Sales Manager Reporting to (Matrix) NA No of Reportees Direct 4-5 Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability PR Skills Dependable Contributor Good Products knowledge Creative & Assertive 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 : 5 to 7 years of Total experience and 1 2 years of First Line experience Age should be around 32 years ",

" 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 Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Reporting to (Business) Zonal Sales Manager Reporting to (Matrix) NA No of Reportees Direct 4-5 Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability PR Skills Dependable Contributor Good Products knowledge Creative & Assertive 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 : 5 to 7 years of Total experience and 1 2 years of First Line experience Age should be around 32 years ",

As the Head of Quality Control at a leading Pharma MNC located in the Chandigarh Vicinity, you will be responsible for overseeing the quality control operations of highly regulated plants, specifically focusing on tablet/capsule/pallets/OSD products with a preference for injections. With over 20 years of experience in the industry, you will demonstrate a track record of excellence in maintaining MHRA and EUGMP profiles, along with multiple successful audit exposures. In the realm of Quality Assurance, you will showcase a deep understanding of the latest updates outlined in the ICH Q9 guidelines. For Quality Control, you will exhibit proficiency in the Updates related to ICH Q2R2 Analytical method validation. Moreover, your leadership skills will be put to the test as you manage a large team, drawing upon your prior experience in handling sizable teams effectively. A key requirement for this role is a proven track record of stability, demonstrating your ability to navigate challenges in the pharmaceutical quality control landscape with resilience and expertise.,

The position of Head of Quality Assurance at a Leading Pharma MNC in Chandigarh Vicinity offers a competitive salary of up to 60 LPA. As a qualified candidate, you must possess over 20 years of experience in managing highly regulated plants, with a strong focus on Tablet/capsule/pallets/OSD products, and preferably injections as well. Your expertise should include an excellent MHRA and EUGMP Profile, along with a track record of multiple successful audit exposures. In the realm of Quality Assurance (QA), you are expected to be well-versed with the latest updates in ICH Q9 guidelines. Additionally, in Quality Control (QC), familiarity with Updates in ICH Q2R2 Analytical method validation is crucial. Your experience should also demonstrate proficiency in handling large team sizes and showcasing proven stability in your previous roles. If you meet these mandatory requirements and are ready to take on a leadership role in ensuring the quality standards of pharmaceutical products, we encourage you to apply for this challenging yet rewarding position.,

Summary As a key resource within the Audit Management Office (AMO), this role ensures effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e. g. , GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA and Swissmedic. The associate acts as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, the role involves monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. About the Role MAJOR ACCOUNTABILITIES Govern processes to effectively manage both internal and external audits across Data, Digital & IT (DD&IT), focusing on GxP (e. g. , GMP, GCP), quality, and regulatory-related audits, along with stakeholder management, remediation tracking, status reporting, and lessons-learned sharing. Act as the single point of contact (SPOC) for audit teams across DD&IT, coordinating audit and inspection activities, ensuring effective communication, and maintaining compliance throughout the process. Notify and mobilize relevant DD&IT stakeholders such as application managers, system owners, QA, Information Security & Compliance (ISC), and SOP process owners for audits and inspections, ensuring timely readiness. Coordinate globally with business teams to ensure audit support tickets are created, tracked, and resolved in alignment with Novartis policies and procedures. Conduct pre-audit meetings to clarify IT scope, agree on auditor pre-requests, align timelines, and ensure stakeholders understand expectations for audits and inspections. Provide advice and guidance to DD&IT teams on GxP and information systems compliance requirements to ensure alignment with regulatory standards such as FDA, EMA, MHRA and Swissmedic expectations. Track and proactively manage audit requests across different time zones, ensuring SMEs respond on time, identifying backups where needed, and escalating delays or deviations as appropriate. Guide DD&IT SMEs by clarifying audit process requirements and supporting them throughout the audit lifecycle, ensuring accurate delivery of requested information. Conduct training sessions on audit readiness, including proper inspection etiquette and effective collaboration during audits and inspections. Collaborate with internal teams to improve and standardize governance frameworks and processes, aiming to reduce audit findings and improve inspection readiness. Escalate compliance deviations and critical quality issues to senior management and coordinate resolution efforts, ensuring corrective and preventive actions (CAPAs) are implemented effectively. Manage relationships at a global level across divisions and functions, including ISC, e-Compliance, and DDIT teams, facilitating cross-functional alignment and collaboration on audit-related matters. Coordinate and participate in audit closing meetings, preparing summaries of findings, tracking observations, and supporting SMEs in addressing them. Partner with security, compliance, and quality experts to identify focus areas, evaluate industry trends, and recommend strategies to improve audit processes and outcomes. Monitor and report on audit findings, remediation actions, and related improvement activities, ensuring compliance, security, and quality gaps are addressed thoroughly. Drive and coordinate key Sarbanes-Oxley (SOX) activities in collaboration with application teams and external auditors, ensuring alignment to SOX IT controls and timely delivery of evidence while minimizing audit-related disruptions. Ensure adherence to security and compliance policies and procedures within the audit management governance framework, while aligning with internal and external quality standards. Minimum Requirements University degree or equivalent. Master s degree in IT, Quality Management, Business Administration, or related fields. Overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements. In-depth understanding of pharma business processes and their interrelationship with IT systems and regulatory frameworks. Proven track record of managing audits, regulatory inspections, and remediation efforts in pharma or other highly regulated environments. Experince with Computer System Validation (CSV), system testing, and adherence to lifecycle validation processes (e. g. , requirements gathering, system design, validation testing, implementation, and maintenance). Knowledge of ITIL processes and best practices. Demonstrated ability to work effectively in large, cross-functional, global organizations. Proficient in Excel, PowerPoint, and other productivity tools for reporting and presentation. Business-proficient in English (written and spoken). Strong communication skills with the ability to articulate expectations and audit requirements clearly to diverse teams and stakeholders. Ability to manage multiple priorities and time-sensitive processes efficiently. ITIL-certified professional. Strong knowledge of validation practices, including GxP, Sarbanes-Oxley (SOX), and pharmaceutical quality compliance standards. understanding of CSV lifecycle processes, including risk assessment, traceability matrix development, protocol execution, and impact analysis. Business knowledge or experience in IT s role supporting audit and compliance functions within regulated industries. Expertise in Computer System Validation (CSV) testing methodologies and frameworks. ? Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www. novartis. com / about / strategy / people-and-culture Commitment to Diversity and Inclusion: Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

" 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 Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Reporting to (Business) Zonal Sales Manager Reporting to (Matrix) NA No of Reportees Direct 4-5 Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability PR Skills Dependable Contributor Good Products knowledge Creative & Assertive 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 : 5 to 7 years of Total experience and 1 2 years of First Line experience Age should be around 32 years ",

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbeing needs of our people while helping make their working life experience more rewarding. Whats in it for you To grow with a global company and learn more about key global benefits initiatives around the world. S&P Global puts our people first, and you will have the opportunity to participate in making positive change through global programs such as Wellbeing Reimbursement, Global Education, Global Parental Leave, Flexible Time Off program, Global EAP, Insured and Retirement benefits in the EMEA region. Responsibilities Manage benefits administration, renewals and day-to-day operations Support benefits programs involving the research and implementation of plans and programs as well as managing competitive benefits offered in the APAC region Subject matter expert for all benefits queries and escalations while also providing guidance and support to various business units Work closely with the external vendors, local leadership of the respective countries, HR partners, and other functions to offer best in class benefits and service to our employees Support APAC benefits projects and implementation related projects from beginning to end including benefits communication creation Develop and maintain policies and other documentation to educate all employees about the companys benefits programs. You'll be asked to work from office 2 days a week. What Were Looking For: Basic Required Qualifications: 4 years' minimum benefits experience Fluent English Exposure to managing benefits plans including benefits related regulatory and tax requirements Benefits project management skills. Capable of managing multiple tasks in an organized manner whilst interacting with various external and internal stakeholders Ability to engage and communicate effectively with employees and stakeholders while understanding their needs Microsoft Excel and PowerPoint experience. A self-starter that is motivated to achieve results whilst also being a team player Accurate, with great attention to detail A positive, flexible and proactive approach Additional Preferred Qualifications: German or French language will be beneficial Bachelor's degree desirable Workday knowledge is a plus If you meet the above qualifications and are passionate about designing and managing employee benefit programs, we would love to hear from you. Return to Work Have you taken time out for caring responsibilities and are now looking to return to workAs part of our Return to Work initiative, Restart, we are encouraging enthusiastic and talented returners to apply, and will actively support your return to the workplace. Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. Recruitment Fraud Alert If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, pre-employment training or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here. ---- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ---- HUMRES202.1 - Middle Professional Tier I (EEO Job Group)

Preferred Education/ Qualification : B. Pharm/M. Pharm/M. Sc. Experience : 6 8 years of experience in Quality Assurance / MQA of sterile dosage manufacturing facility /Technology Transfer/Validation. Core Competencies : Technology Transfer of injectables Change Management process Risk assessments principles and tools Validation of manufacturing equipment s Drug Product Process validations Regulatory requirements Compendial Changes Technical Skills : Fundamental knowledge on manufacturing and Quality control activities, such as Solution preparation, filling, terminal sterilization, visual inspection, packing, in process sampling and analysis. Technical document review skills Knowledge in change control assessment Knowledge on manufacturing process such as stopper processing, sampling and dispensing, solution preparation, Component Preparation, Filling and Capping of Drug Product. Should be capable of handling regulatory inspections USFDA/MHRA/TGA, etc. , Behavioural/ Any Other Skills: Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship Acts Decisively: Makes decision in a timely manner based on available information Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives Critical thinking and Compliance mindset. Core Responsibilities : Good performance, partially independent, reviews trends and data Responsible for review of Manufacturing documents such as SOPs, Process validation, cleaning validation, cleaning process verification documents, Batch manufacturing records, Exhibit batch plan, Exhibit batch Summary Reports. study protocols and reports. Tracking of change controls, Providing QA Impact Assessment, preapproval, post approval & closure of action items. Coordinating with CFT for addressing & resolving of Review Comments for timely Closure. Review of product & process related SOP, Job aids & Forms. Review and approval of NVPC, PH and conductivity. Review and approval of APQR s. Report any non-compliance to the Supervisor Should have trouble shooting abilities in manufacturing Quality area, which helps the organization to develop, implement and achieve its mission, vision and values. Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the Efficiency. Experience in handling regulatory, corporate and internal auditors/ inspectors. Work Location Assignment: On Premise Quality Assurance and Control #LI-PFE

Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis 32S/32P Reference Standards 32S/32P Characterization of Impurities 32S/32P Justification of Specification 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification report based on the performance of material at test. To prepare justification reports towards reduction of tests in Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing. Preparation/Review of SOPs Preparation of cleaning validation method protocol and report Required Skills Data Integrity (ALCOA+ principles) | Advanced Regulatory knowledge (USFDA, MHRA, ICH Q series) | Advanced Method Validation Documentation | Advanced Method Development Understanding | Advanced CTD / eCTD Module Preparation (Primarily Module 3.2.S & 3.2.P) | Advanced

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution. Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines. Demonstrates knowledge of key processes, procedures and tools. Regulatory Skills: Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry. Leadership Skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format. Ability to comprehend and summarize complex technical data. Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.

JOB SUMMARY: To ensure on handling of documents like analytical test procedures, specifications, standard operating procedures from initiation till implementation. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To ensure sampling activities are performed as per SOP and sample integrity are maintained till analysis completion. To ensure working/reference standards are made available for analysis and timely qualification of standards within due date. To involve in investigations and to collaborate with cross function team for root cause determination and implementation of effective CAPA. To ensure safety and use of required personal protective equipments during day-to-day activities. Responsible for carrying out any other responsibilities assigned from time to time orally or in writing by HOD. To maintain and enhance quality index of the site unit data elements pertaining to QC function. Identify the training need and organize for the training to concerned group in QC to avoid event and unconfirmed OOS due to errors during analysis. ESSENTIAL JOB FUNCTIONS: To ensure stability samples are charged and analysis completed within the due date and stability chambers are monitored and maintained at respective conditions. To ensure effective analytical methodology are placed for testing. To ensure analytical method validation and analytical method transfer activities are completed and validated methods are adopted for testing. To ensure sampling activities of RM/Intermediates/Finished as per approved standard operating procedures. To ensure stability study sampling, stability study chamber monitoring and timely withdrawal and completion of analysis. To review the analytical method validation, method transfer, regulatory submission related documents, working reference standard procurements. To co-ordinate self-inspection (internal audit) and its compliances. To approve the lab event/out of specification/our of trend/our of calibration/CAPA/change control/deviation. Ensure trend of quality control errors and effective CAPA implementation. To monitor the compliance with the requirement of GMP. To participate in the management reviews of process performances, product quality and of the quality management systems and advocating continual improvement. To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. To conduct training program and ensure it effectiveness. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To follow safety & use of required personal protective equipment during day to day activities. To ensure maintenance of housekeeping at shop floor and reporting day to day activities to QC head and in absence delegate change to second line manager. To participate in laboratory internal audits, customer audits, health authority inspection. Awareness of IMS systems (ISO14001:2015 and ISO45001:2018) Travel Estimate Low Job Requirements Educational Qualification M.Sc Chemistry Experience 15+ years experience

" 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 ",

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Key Accountabilities (2/6) Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (3/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Key Accountabilities (4/6) Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

" 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 Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sitedat Roorkee, Uttarakhand and Salisbury, Maryland, USAengaged in manufacturing of Tablets and Capsules. 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 team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization ",

Position: Site Head (Sr. Manager) - Production Location: Ranjangaon, Near Pune Reporting To: Head - Manufacturing Operations Industry: Pharmaceutical Manufacturing Experience: 15+ years in Plant leadership roles, preferably in pharmaceutical or manufacturing industries About Fresenius Kabi At Fresenius Kabi, we are driven by a commitment to improve the quality of lives: We are Committed to life. We strive for continuous innovation with our outstanding manufacturing capabilities, unique channel access, and customer proximity. With our four complementary business areas BioPharma, Pharma (primarily IV drugs and infusion therapy), Medical Nutrition, and MedTech; Fresenius Kabi plays a vital role in the treatment of chronically and critically ill patients across various healthcare settings. For instance, over 70% of our IV drug units shipped in the US are on the Essential Medicines List of the US Food and Drug Administration, emphasizing the importance and impact of our products. All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations. For us, care is a fundamental obligation, mission, and daily source of inspiration. It is the momentum that pushes us forward to help elevate the quality of life for both caregivers and those who need it most: critically and chronically ill patients. By providing essential medicines and technologies for infusion, transfusion, and medical nutrition, we are helping advance the future of healthcare, making it even more accessible, reliable, and in tune with current and future needs. Our principles: The Fresenius Principles form the basis of our company culture, with which we support our #FutureFresenius strategy. They describe what we stand for and how we operate, collaborate, approach challenges and make decisions as individual Fresenius employees and as a whole team. Role & responsibilities Confirm that production is carried out by appropriately qualified, experienced, and trained personnel. Ensure GMP-compliant operations across all manufacturing activities. Verify that manufacturing operations are clearly defined, systematically reviewed, and proven capable of consistently producing products of the required quality. Ensure manufacturing processes are properly validated. Provide assurance that critical process parameters are identified, controlled, and any changes are validated. Implement change control, event handling, and CAPA/action management processes in accordance with global Quality Management (QM) documents, monitor and trend accordingly. Maintain accurate records for equipment usage, calibration, maintenance, and repair including dates and responsible personnel. Oversee manufacturing equipment qualification, validation, and calibration programs. Ensure proper storage and handling of materials and products covering receipt, quarantine, sampling, storage, labeling, dispensing, processing, and packaging according to written procedures. Execute yield checks and quantity reconciliations to confirm no discrepancies exceed acceptable limits. Conduct in-process and environmental controls as required, ensuring accurate recording. Contribute to investigations of product quality defects. Control reprocessing or reworking of materials to prevent unauthorized use. Prevent cross-contamination and mix-ups during manufacturing, packaging, and labeling operations. Implement and monitor progress toward EHS policy objectives. Create, manage, and update documentation related to the Environmental Health & Management System. Maintain surveillance of compliance with legal and organizational requirements. Report EEHS performance metrics to top management. Conduct regular reviews of occupational risks and environmental aspects. Provide training and awareness to employees to minimize accidents and environmental impact. Liaise with corporate and global EEHS representatives regarding relevant issues. Conduct audits of the Environmental, Energy, and Health & Safety Management System Ensure realistic commitment to the production plan based on machine utilization and manpower availability. Collaborate with the Site Head to escalate and resolve key events affecting production, quality, and safety. Review and propose capital expenditure (CAPEX) and operational expenditure (OPEX) budgets. Lead and drive continuous improvement projects by identifying suitable opportunities and overseeing their implementation. Provide ongoing coaching and support to team members to build capability and strengthen performance. Proactively mitigate potential conflicts between internal and external stakeholders.

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 and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. 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 team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization. JOB RESPONSIBILITIES : ;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work US Drug Dossier Authoring, Reviewing and Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation and Submission Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements Reporting and Maintenance Maintain regulatory files/database

(We are looking fo the Immediate joining candidates or willing to leave early for their current company) Role & responsibilities HPLC Analysis of Solid Orals/Nasal hands on experience on QC activities, RM, Packing, In Process and Finished Products Compliance with GMP/GLP Practices Preferred candidate profile 2-7 years of experience Prior experience of working in Regulated plants (USFDA/MHRA Approved) Perks and benefits Working in a state-of-the-art fully automated world class manufacturing. Opportunity to work on diverse dosage forms in a multi-product facility. Attractive attendance bonus & Special Allowances Unmatched opportunities to learn and grow Thanks & Regards Dhivakar D BVR People Consulting dhivakar@bvrpc.com

Roles and Responsibilities Ensure compliance with USFDA, MHRA, and other global regulations through quality control management. Conduct regular audits to identify areas of improvement in production processes. Collaborate with cross-functional teams to resolve quality issues and improve overall product quality. Develop and implement corrective actions plans to address non-conformities found during audits. Desired Candidate Profile 10-15 years of experience in pharmaceutical industry with expertise in HPLC analysis. B.Tech/B.E. degree in Chemical Engineering or related field;. Strong understanding of GMP guidelines, ISO standards, and regulatory requirements such as USFDA & MHRA.

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form PURPOSE AND SCOPE: Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal standards, and best practices. . PRINCIPAL DUTIES AND RESPONSIBILITIES: Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes; applies creative problem-solving to resolve a wide range of technical and operational issues. Manages the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards. Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the U.S., Canada, EU, and Asia-Pacific. Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards. Collaborates cross-functionally with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions. Interprets and applies key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, etc.). Leads and contributes to the development, revision, implementation, and training of departmental SOPs, WIs, and standardized publishing processes to ensure consistency, efficiency, and regulatory compliance. Assists in the management and continuous improvement of templates, procedures, and tools used to support global submission activities. Troubleshoots technical issues related to publishing tools and document formatting, particularly within MS Word and Adobe Acrobat, and supports resolution of validation errors. Participates in evaluating and implementing new regulatory technologies; ensures alignment with infrastructure standards and supports transitions from legacy systems to electronic platforms. Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs. May mentor junior staff, provide publishing guidance, and act as a resource for complex submissions. Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines. Ensures compliance with all applicable regulations, company policies, and the Code of Business Conduct. May escalate complex issues for resolution and assist with additional projects or duties as assigned. Assist with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function EXPERIENCE AND REQUIRED SKILLS : Bachelor s Degree required; Advanced Degree desirable Minimum five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. Proven expertise in the preparation, compilation, publishing, and validation of eCTD submissions in support of U.S. (FDA), Canada (Health Canada), EU (EMA, MHRA), and Asia-Pacific (PMDA, TGA, NMPA, etc.) regulatory requirements. In-depth knowledge of electronic publishing tools and Regulatory Information Management (RIM) systems. Proficiency with electronic document management systems (EDMS) and advanced knowledge of document formatting tools, particularly MS Word (template and style management) and Adobe Acrobat (PDF optimization and troubleshooting). Strong understanding of global regulatory submission guidance. Demonstrated experience managing multiple submission projects in parallel, with proven ability to meet tight deadlines and deliver high-quality, technically compliant outputs. Strong organizational skills and meticulous attention to detail; able to identify and resolve issues independently and proactively. Excellent written and verbal communication skills, with the ability to clearly document processes, communicate submission requirements, and collaborate effectively across teams. Experience with electronic submissions, specifically eCTD, required. Strong understanding of document management processes in a regulated pharmaceutical environment. Demonstrated understanding of the drug development process and project management experience is highly preferred. Proven experience in developing, revising, and maintaining departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and internal processes, with a focus on continuous improvement and regulatory compliance. Strong software troubleshooting skills. EOE, disability/veterans