3748 Pharma Jobs - Page 22

Interview for SVP & Injectable Pharma Formulation Plant in Bharuch on Company / Permanent Payroll Experience: 2 to 6 Yrs CTC: As per industry Work Location: Dahej Send CV on sdpbharuch@gmail.com with Subject: SVP Bharuch & Call 7600033423 Free Job Required Candidate profile Autoclave Operator Granulation Operator Mixing Operator Grinding Operator Cartonator Operator Washing Tunnel Operator Ampoule Filling Operator Vial Filling Operator Vial Sealing Operator Lyo Operator

Interview for SVP & Injectible Pharma Formulation Plant in Bharuch on Company / Permanent Payroll Experience: 2 to 6 Yrs CTC: As per industry Work Location: Dahej Send CV on sdpbharuch@gmail.com with Subject: SVP Bharuch & Call 7600033423 Free Job Required Candidate profile Autoclave Operator Granulation Operator Mixing Operator Grinding Operator Cartonator Operator Washing Tunnel Operator Ampoule Filling Operator Vial Filling Operator Vial Sealing Operator Lyo Operator

* Lead & manage the team ensuring business targets are met. * Manage recruitment of Sales Persons. * Develop & Implement sales strategies to achieve revenue goals. * Provide training & assign task to Sales team. * Manage Performance report of Team. Required Candidate profile Any Graduate with Min. 2 year Sales Experience Must be local and have area knowledge Must have valid document of last company Age between 24 to 40 M-hitisha.sresthinfo@gmail.com C-9106057150 Perks and benefits On Roll Job + High CTC Incentives + Allowances

Job Description :- Note : Location is Pan India not Vadodara who are interested for Pan India , Please apply. This position is for 1 year contract with LTTS only initially later can convert for On role Exp. In Chemical / Sp. Chemical / Pharma / Petrochemical Industry Responsible for Mechanical Works such as Equipment Erection, Piping works, etc. Coordinate with Contractor Supervise Contractors personnel in the field and prefabrication Ensure compliance with HSE standards and regulations Assist to client for finalizing contractor, material vendor Responsible for checking of fit up of piping (Fabrication Shop) Works To understand P&ID and Isometric drawings for Piping works To forecasting requirement of material, manpower and tools & tackles as per work front & project requirements Responsible for erection of Piping as per Isometric/P&ID Monitor the work activities with regard to full compliance with the work permits and to detect further unsafe conditions or actions Report all safety observations & induced measures in report Ensure compliance with project standards and specifications Check and ensure right sequence of workflow Co-ordinate with other contractor's personnel for interfaces. Keeping track record of increasing of quantity w.r.t BOQ and same to inform the client for amendment Follow up status of the work and compare planned and actual figures Reporting of deficiencies regarding quality of the work Monitor contractor's personnel planned and actual Compile and follow up of punch items list Co-ordinate with other external team members Log and file all document necessary for daily work and as built Check and execute isometric drawings Preparation of test packs and material for hydro tests Responsible for certification of Contractor RA bill. Support for Pre-Commissioning and Commissioning Works Experience : 7 + years Industries Prefered : Chemical, FMCG, CPG, Pharma are relatable Steps : 1) Apply through Naukri 2) For Speed response, Please apply on below link also https://ltts.sensehq.com/careers/jobs/22842?utm_source=LINKEDIN&utm_medium=SOCIAL_MEDIA

SAP QM Tech Consultant with S/4HANA full cycle experience, PP/PI integration, MES interfacing, and strong analytical skills. Drives workshops, config/testing, data migration, and cross-module collaboration. Pharma domain knowledge preferred.

We are seeking adynamic Product Manager to lead the strategy, development, and growth ofour Agentic AI platform a suite of AI-powered agents designed toautomate complex, cross-functional enterprise tasks- You will define productvision, identify opportunities across industries (e-g-, chemicals,manufacturing, logistics, compliance), and collaborate with engineering,design, and go-to-market teams to bring cutting-edge automation solutions tolife- KeyResponsibilities Product Strategy & Vision Define and own the roadmap for Agentic AI products across key verticals- Shape the vision for autonomous AI agents using LLMs, ML, RPA, and computer vision- Customer & Market Insights Conduct customer discovery, competitor analysis and market validation- Translate real-world enterprise pain points into scalable product features and flows- Execution & Delivery Work closely with engineering and AI/ML teams to scope and deliver features using agile methodologies- Prioritize backlog, define epics/user stories, and drive end-to-end product delivery- Cross-functional Leadership Collaborate with design, sales, marketing, and solutions teams to drive adoption and revenue- Lead product demos, internal enablement, and client presentations- Product Lifecycle & Governance Define frameworks for AI agent governance post-deployment (e-g-, ownership, monitoring, compliance)- Ensure ethical and reliable performance of AI agents within enterprise environments- Requirements 58 years of product management experience in B2B SaaS, AI, automation, or enterprise software- Experience working with or building AI-powered products LLMs, computer vision, RPA, or ML- MBA or degree in engineering, computer science, or related field- Strong grasp of process automation in industries like manufacturing, chemicals, pharma, or logistics is a plus- Ability to translate ambiguous requirements into clear product roadmaps and features- Technical depth to work with engineering and data teams; familiarity with APIs, workflows, and system integrations- Excellent communication, prioritization, and stakeholder management skills- What We Offer A chance to shape a category-defining product in autonomous enterprise automation- High ownership, fast-paced environment with strong support from design and engineering- Key Skills Product Discovery, CustomerDiscovery, Market research, Competitor analysis, Beta testing, MVP, GTM,Product Execution, Product Backlog, UserExperience

As an RWD SME / RWE Execution Data Scientist, you will focus on executing innovative methodologies and AI models to mine RWD on the data42 platform- You will be the go-to authority for leveraging diverse RWD modalities patterns crucial to understanding patient populations, biomarkers, and drug targets, accelerating the development of life-changing medicines- About the Role Duties and Responsibilities: Collaborate with R&D stakeholders to co-create and implement innovative, repeatable, scaleable and automatable data and technology solutions in line with data42 strategy- Be a data SME, understand RWD of different modalities, vocabularies (LOINC, ICD, HCPCS etc-), non-traditional RWD (Patient reported outcomes, Wearables and Mobile Health Data) and where and how they can be used, including in conjunction with clinical data, omics data, pre-clinical data, and commercial data- Contribute to data strategy implementation such as Federated Learning, tokenization, data quality frameworks, regulatory requirements (submission data to HL7 FHIR formats conversion, Sentinel initiative), conversion to common data models and standards (OMOP, FHIR, SEND etc-), FAIR principles and integration with enterprise catalog Define and execute advanced integrated and scaleable analytical approaches and research methodologies (including industry trends) in support of exploratory and regulatory using AI models for RWD analysis across the Research Development Commercial continuum by facilitating research questions- Stay current with emerging applications and trends, driving the development of advanced analytic capabilities for data42 across the Real-world evidence generation lifecycle, from ideation to study design and execution- Demonstrate high agility working across various cross-located and cross-functional associates across business domains (commercial, Development, Biomedical Research) or Therapeutic area divisions for our priority disease areas to execute complex and critical business problems with quantified business impact/ROI- Draft and edit high-level research documents (proposals, protocols, statistical analysis plans)- [optional] Knowledge of governance, ethical and privacy considerations [optional] Ideal Candidate Profile: PhD or MSc- in a quantitative discipline (e-g-, but not restricted to Computer Science, Physics, Statistics, Epidemiology) with proven expertise in AI/ML- 8+ years of relevant experience in Data Science (or 4+ years post-qualification in case of PhD)- Extensive experience in Statistical and Machine Learning techniques: Regression, Classification, Clustering, Design of Experiments, Monte Carlo Simulations, Statistical Inference, Feature Engineering, Time Series Forecasting, Text Mining, and Natural Language Processing, LLMs, and multi-modal Generative AI- Good to have skills: Stochastic models, Bayesian Models, Markov Chains, Optimization techniques including, Dynamic Programming Deep Learning techniques on structured and unstructured data, Recommender Systems- Proficiency in tools and packages: Python, R(optional), SQL; exposure to dashboard or web-app building using PowerBI, R-Shiny, Flask, open source or proprietary software and packages is an advantage- Knowledge in data standards e-g- OHDSI OMOP, and other data standards, FHIR HL7 for regulatory, and best practices- Good to have: Foundry, big data programming, working knowledge of executing data science on AWS, DataBricks, SnowFlake Strong in Matrix collaboration environments with good communication and collaboration skills with country/ regional/ global stakeholders in an individual contributor capacity- High learning agility and adherence to updates in industry and area of work- Optional Experience in Biomedical Research and development in pharma is a bonus-

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries- Working as part of the global ICON University, the purpose of this role is, to provide support for the development and delivery of learning and development solutions to meet the identified needs of ICON s employees at all levels, enabling them to develop and grow as trusted partners to all our customers, external and internal- To support the ICON Learning management system by providing timely customer service via ICON s help desk application- Responsibilities: Recognize, exemplify and adhere to ICONs values, which center around our commitment to People, Clients and Performance- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs- Provides programme support as assigned Provide support for external and internal audits and/or client requests for training documentation on study staff including preparation of employee reports (training histories or learning plans when requested) and provision of scanned or actual paper files, when necessary- Maintain departmental files, as necessary Demonstrate leadership by working at a high level of quality with minimal supervision Mentor and coach other Learning and development coordinators as required Provide timely and professional customer service via ICON s help desk application Provide support for ICON systems that promote learning and development Ability to communicate effectively with internal and external customers Generate reports as necessary Perform additional activities and responsibilities related to the job role and support ICON University activities as assigned- Proactively informs Icon University management of department and or learning and development related issues- Work collaboratively and proactively as part of the wider ICON University team To perform this job successfully, an individual must be able to perform each essential duty satisfactorily- The requirements listed below are representative of the knowledge, skill, and/or ability required- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions- US/LATAM/CAN: experience in relevant discipline in Training, Learning Development, Education, Management, HR or other EU/APAC: In depth proven experience in relevant discipline in Training, Learning Development, Education, Management, HR or other Demonstrates the ICON competencies Demonstrates excellent interpersonal and communication skills (oral and written)- Ability to work effectively and efficiently on global networked computers using current systems, and/or software including the MS Office applications: Excel, Powerpoint and Word- Demonstrates high level of organisational skills, attention to detail and accuracy in work completion- Ability to work as part of a remote global team Ability to work effectively and efficiently with current learning and delivery technologies Fluent in English (written and oral) Ability to travel domestically and internationally as necessary and not expected to exceed 10%- What are we looking for: Min- Graduate or should have Bachelors Degree in any stream Should have 2-3 years experience in Cornerstone LMS Should have Advance Excel knowledge experience Should have good communication interpersonal skills Open for Hybrid role (Chennai- Thooraipakkam) Our benefits include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being- Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others-

BharatCares (CSRBOX Foundation) is the social impact arm of CSRBOX. We believe in innovations, technology, and scale for providing solutions to the problems that we as a society have been grappling with. BharatCares works as a social solution bridge for communities, innovators, and funders to get the best implementation model in place. We strive to provide better education, employability skills, and entrepreneurial ecosystem support to underprivileged communities. Curious about what Life @ CSRBOX looks likeExplore: About the Position Responsibilities Project Development: Collaborate with the CSRBOX team to conceptualize, design, and develop innovative education-focused projects aligned with CSR objectives and local community needs. Stakeholder Engagement: Build and maintain strong relationships with diverse stakeholders, including government bodies, non-profit organizations, schools, teachers, parents, and community members, to ensure effective project implementation and sustainability. Project Implementation: Lead the successful implementation of education projects, coordinating with internal teams, external partners, and beneficiaries to ensure the timely and efficient delivery of project objectives. Monitoring and Evaluation: Develop and implement comprehensive monitoring and evaluation frameworks to track project progress, assess impact, and make data-driven recommendations for continuous improvement. Training and Capacity Building: Organize and conduct training workshops and capacity-building programs for teachers, school staff, and other stakeholders to enhance their skills and knowledge in various areas of education. Documentation and Reporting: Maintain accurate project documentation, including progress reports, success stories, case studies, and impact assessments, to share with relevant stakeholders and donors. Budget Management: Assist in budget planning and ensure effective financial management of projects to optimize resource utilization and meet project goals. Advocacy and Networking: Represent CSRBOX at education-related events, conferences, and forums to advocate for quality education and explore potential partnerships and collaborations. Travel: Willingness to travel occasionally to project sites and other locations for project-related activities and stakeholder meetings Mandatory Qualification and Experience: Bachelors degree in Education, Social Sciences, Development Studies, or a related field is required. A masters degree is preferred. Minimum years of experience in education project management, preferably in the context of CSR initiatives or social development programs. Fluency in the local language is essential to effectively engage with stakeholders and beneficiaries. Strong understanding of the education sector, including issues related to access, quality, equity, and inclusion. Proven track record of successful project implementation, including project planning, execution, and monitoring. Excellent interpersonal and communication skills, with the ability to engage and communicate effectively with diverse stakeholders. Experience in conducting needs assessments, data analysis, and impact evaluations is desirable. Ability to work independently and as part of a team, managing multiple tasks and deadlines effectively. Proficiency in using MS Office suite (Word, Excel, PowerPoint) and other relevant software applications. Passion for social impact and a strong commitment to driving positive change in the education sector. Desirable

Specialist Regulatory Affairs LCM - Strategic Growth Products Date: 14 Jul 2025 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma Location: Andheri, Mumbai (Hybrid working opportunity) About ADVANZ PHARMA ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About Business Unit The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. What You ll Do: Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Renewal Application and Annual Maintenance Variation Application Notification of Change in Marketing Status, sunset clause exemptions where applicable Notification of drug shortages Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Orphan Designation Maintenance (where applicable) Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Innovative Medicines (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through MA will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Formal training in Regulatory Knowledge, Skills Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Medical writing and Review experience Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines post approval changes such as PIP modifications and label expansions. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. Why ADVANZ PHARMA The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you ll be empowered to own your work, explore new possibilities, and make things happen. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

Select with space bar to view the full contents of the job information. Specialist Regulatory Affairs LCM - Strategic Growth Products Job Details | AdvanzPharma We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Specialist Regulatory Affairs LCM - Strategic Growth Products ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM for Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. Strategic Growth Products will include Innovative Medicines (NCEs or Biologics), Biosimilars and Specialty Generics that would require significant technical inputs on CMC and Clinical side during post approval phase. Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Notification of Change in Marketing Status, sunset clause exemptions where applicable Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Biosimilars (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through M&A will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Knowledge, Skills & Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Proven Biosimilars regulatory experience for EU preferably Life cycle activities. Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines or/and complex CMC post approval changes. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset & Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. *Please include a CV and Cover letter. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. Provider Description Enabled We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data centre "JSESSIONID" is placed on the visitors device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another

Previous job Next job JOB DESCRIPTION Mumbai Job Description Generate sales through close and regular interaction with assigned customers, such as healthcare practitioner (HCPs) and by developing new projects that meet sales objectives Make calls on existing or potential customers such as healthcare practitioner (HCPs) and serve as representative of the Company in all matters concerning product and service delivery Keep abreast of new products or services and other general information of interest to customers while continuously upgrading ones product knowledge and selling techniques Transform information captured from the field/shoppers and from interactions with customers/external partners to insights for developing programs and plans that will further build the business Job Qualifications Minimum Bachelor s degree required. B. Pharm or Science graduates preferred Experience and/or training in chain pharmacy, specifically in Field Sales, Pharma sales and Sales Management in the Pharmaceutical industry, preferred.

Designation: Invitro ADME Sientist Job Location: Bangalore/Hyderabad Department: Discovery Biology About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines: Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self. Compliance to Syngene s quality standards at all times. Job Purpose Support the ADME team by planning and conducting the metabolic stability, Single point inhibition, reversible CYPIC50 inhibition and TDI-IC50 shift assays using Human liver microsomes with highest quality Time management and multi-tasking skills to meet the demand of high-volume wave 1 ADME assays to complete multiple projects within timelines. Contemporaneous recording of lab activities and experiments performed, practices high level of house keeping Adhere to all safety rules and maintains safe workplace. Predominantly laboratory-based job Key Responsibilities: Extensive experience in planning metabolic stability, CYP inhibition assays Design and execute in-vitro Single point inhibition, reversible CYPIC50 inhibition and TDI-IC50 shift assay with human liver microsomes. Seamless coordination with BA-DMPK group to design in-vitro CYP inhibition studies. Preparation of SOP s and EOPs. Reporting of executed studies without any noncompliance. Reporting of study results clearly in the cross functional scientific meetings. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team. Educational Qualification: M Pharm. in any pharmaceutical science or M Sc. in biological science. Technical/functional Skills: Comprehensive understanding of in vitro ADME assays and technical expertise in trouble shooting the assays In depth understanding of biochemical and aspects of enzyme kinetics is highly desirable related to the metabolism Good, demonstrated knowledge in software such as Microsoft excel and Graph pad prism Demonstrated cross functional leadership capabilities Experience with automation is desirable Experience: A M Pharm. in pharmaceutical sciences or M SC in biological science with six or more years of Industrial experience in DMPK/ADME research. Behavioral Skills: Demonstrate ability to be a team player. Commitment to deliver the study reports within the agreed timelines Adaptability to changes in the dynamic lab environment Communicate confidently with colleagues and collaborators in the meetings and presentation of study reports and evidence of publications in the PEER reviewed Journals Equal Opportunity Employer: .

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific: Functional Responsibilities: Responsible & accountable towards safety & compliance in all the work activities in the own responsibility area(s). Monitor & confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed. Adhere to the highest standards of quality, integrity & compliance for every work activity. Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar. Attend all assigned mandatory trainings related to data integrity, health and safety measures. Participate in & support the trainings on procedures, protocols and On-the-Job activities. Compliance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s). Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls. Primary Responsibilities: Sample analysis for in-process, finished product, stability and miscellaneous samples. Responsible to troubleshoot problems, provide technical guidance, train lab personnel in fundamental lab techniques and procedures as a mentor and coach. Responsible for supporting the routine testing operations, ensuring compliance with regard to observation data sheet along with the analytical data, analysis report and handing over the same on time to QA or the Client. Preparation and review of batch release documents like STPs with observation data sheet, Method transfer and validation protocols etc. Responsible to review of Analytical data, QMS documents related to batch release and stability study activity related documents. Responsible to review the Method transfer, Method validation& Verification protocols. Coordinating and supporting for the review and release of Method transfer, Method validation & Verification activity and its records/reports and results. Responsible to manage a team supporting for routine testing operations, Ensuring Compliance with regard to observation data sheet along with the analytical data, analysis report on time to QA and Customers.

Follow the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment and adhere to the highest standards of quality, integrity & compliance for every work activity. Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar. Attend all assigned mandatory trainings related to data integrity, health, and safety measures. Compliance to Current Good Manufacturing Practices and Good Documentation Practices. Adherence to Standard Operating procedures, Operational control Procedures. Participate in & support the trainings on procedures, protocols, and On-the-Job activities. Follow the discipline of reporting structure at times of escalation. Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s). Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls. Safety and DI Responsibilities: Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security. Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety. Understand all necessary safety protocols and always follow the same to ensure safety for all. Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals. Specific Responsibilities: Follow good aseptic behavior inside Biologics operations facility. Perform all the upstream activities like Assembly preparation, Media Preparation, Vial thaw, Feed preparation and filtration, Bioreactor Operations to Batch Harvest. Monitoring and process control of the specific Operations of the upstream. Maintenance of Quality records. Traceability from raw material till finished product. In-process product sampling and storage. Preparation and review of operation related documents. Perform room owner responsibility for the assigned USP area. Perform equipment/instrument ownership related responsibilities related to USP. Initiate Complaint Slips (work orders) for USP related areas and equipment. Coordinate with QA for line clearance. LNS system monitoring and LN2 tank refilling. Gas Bank Monitoring. Maintaining process area All-time ready for Inspection/ audit purpose. Preparation of general upstream related procedures, protocols, risk assessment and BMRs. Execution of protocols related to upstream related activity and equipment / instrument qualification. General consumable stock review and record maintenance Ensure PM planner and calibration planner are followed. Execution of batch activity as per BMR and report nonconformity to the supervisor. Issuance of annexures, RM, consumables and BMRs. Tracking of work order status and ensuring timely closure. Involve in downstream related activities under supervision of downstream supervisor.

JOB/ROLE DESCRIPTION The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Responsibilities At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. Compliance with safety policy and procedures: Facilitate and monitor the performance of regular facility walkthroughs and internal quality audits for biologics operations to ensure adherence to the implemented systems and compliance with regulatory requirements including data integrity assessment. Responsibility for establishment and implementation of a robust cleaning, sanitization & sterilization process. Monitoring of equipments which are related to Facility Management and responsible for review of logbooks and reports. Lead and monitor management of garments and general consumables as per BMP5 facility requirements. Review the SOP s, protocols, study reports procedures in BMP5 operations. Lead and monitor timely tracking of Operational and Compliance Metrics for manufacturing Operations and management reporting. Facilitate and monitor the implementation of the approved CAPA for the Biologics Operations in Facility Management section. Facilitate and monitor waste management as per the established procedures and adherence to the Clean Room Behavior by all the personnel working in the clean rooms. Leading the team in effective manner. Leading the commissioning and qualification & requalification of all equipment s which are related to facility management. Support for timely reporting of deviations, appropriate investigations to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Support for appropriate manufacturing investigations for OOS and results and customer complaint to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Support for risk management for biologics operations (Facility Department) which covers the following elements and ensured proposal and implementation of appropriate risk mitigation actions (CAPA). Quality and Compliance Risks Operational Risks Data Integrity Risks Facilitate and monitor timely preparation, review, and approval of GMP Documentation for BMP5 Facility Management related major equipment s. Standard Operating Procedures (EOP, IOP and SOP). Protocols and Reports Any other GMP relevant documentation. Support for control of documents and records within the Manufacturing Operations. Execution of BMP5 facility related activities by adhering to Syngene s safety and GMP practices. Other competencies required for the role Follow the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment and adhere to the highest standards of quality, integrity & compliance for every work activity. Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar. Attend all assigned mandatory trainings related to data integrity, health, and safety measures. Compliance to Current Good Manufacturing Practices and Good Documentation Practices. Adherence to Standard Operating procedures, Operational control Procedures. Participate in & support the trainings on procedures, protocols, and On-the-Job activities. Follow the discipline of reporting structure at times of escalation. Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s). Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls. Safety and DI Responsibilities: Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security. Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety. Understand all necessary safety protocols and always follow the same to ensure safety for all. Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals. Equal Opportunity Employer . Pls visit us at https://syngeneintl.com/ to know more about us and what we do.

Primary Job Function Achieving assigned territory/ geography wise sales target Carrying out effective field work without direct day-to-day supervision Report field work in daily basis on assigned online system Meeting Call Average, Coverage, Frequency coverage Norms of assigned division Core Job Responsibilities Generate maximum prescriptions & increase market share Promote the Division s products as per strategy Relationship Building with the Stake holders (Doctors, Chemists, Stockiest etc) Facilitating Strategy building A good Brand Ambassador Minimum Education BSc/B. Pharma 3 +Yrs of experience. Minimum Experience/Training Required Candidate with prior/current experience in same therapy. Candidate from MNC and top Indian Pharma companies will have added advantage. Fluent and confident in communication LOCATION: India > Lucknow : Halwasiya Husse Road, 2nd Floor, Gyan Ganga Market t

Therapy Business Manager Successfully launch assigned brands in a specialty segment in line with brand strategy Plan and consistently achieve patients on therapy, unit targets and value targets Ensure customer coverage / KOL development in assigned territory as per plan Execute / initiate compliant medico marketing activities Manage distribution channel and monitor services to all stakeholders Proactively plan and execute immediate and medium-term plans for the business in his/her region Record and report all market intelligence to HO Experience 3+ years in specialty segment is desirable. Experience of selling premium brands is essential Required Qualification B. Pharm / M. Pharm / M.Sc. candidates preferred. Other graduates with management qualification can LOCATION: India > Mumbai : BKC Building t

MAIN PURPOSE OF ROLE Summarize the main purpose of the role. Conduct market research and feasibility studies to analyze the viability of alternative business development opportunities. MAIN RESPONSIBILITIES Collect, compile, verify, and analyze financial, competitive, sales, marketing, and other information about potential business partners, new markets, products and services, or other business opportunities so that senior management has accurate and timely information for making strategic and operational decisions. Prepare documents and materials (for example, reports, presentations, information packages) for meetings and negotiations with potential clients and business partners so that the information provided is accurate and appropriate for external distribution. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Associates Degree ( 13 years) Experience/Background Experience Experience Details No Experience LOCATION: India > Bangalore : Thungs Tower t

MAIN PURPOSE OF ROLE Responsible for coordinating and executing activities involving the analysis of business opportunities both in the domestic and foreign markets, aiming at achieving the financial and marketing goals established by the company. MAIN RESPONSIBILITIES Oversee and coordinate the work in a business development team. Coordinate a business development team which evaluates, analyzes, and formulates strategies for business growth. Responsible for the development of key projects and participates the successful closure of business deals. Executes the planning and preparation of business proposals, and supports the provision of recommendations to senior management. Typically without budget or hire/fire authority. Focuses on mentoring, coaching, and coordination. QUALIFICATIONS Education Associates Degree ( 13 years) Experience/Background Minimum 4 years LOCATION: India > Hyderabad : No 1-6-140 t

CORE JOB RESPONSIBILITIES 1. To analyse and prepare working plan for the territory basis the data provides/ market research 2. To be able to follow up, monitor and achieve targets of the territory 3. Implementation & execution of all strategies 4. Stakeholder engagement- doctors, stockist, retailers, chemists and institutions pharmacy 5. Discipline and punctual with set timelines for multiple internal processes 7. Basic computer skills- excel working, word & email exchanges 6. Fast learner and adaptable to change in market 7. Strong communication skills (verbal)- English and local language 8. Effective in-clinic performance 9. Basic understanding and ability to explain anatomy physiology and product portfoli0 10. Organizing Camps (CME) as per the division strategy and customer needs 11. Prescription audit for Abbott brands and other competitors brands 12. Generate POBs for Abbott brands as per the business plan REQUIRED EXPERIENCE Experience 2+ years of experience Fresher with good communication skills and analytical skills may also consider Required Qualification B.Sc. / B.Pharma. LOCATION: India > Pune : Tara Heights, CTS No.20/2, Final Plot, no.18/2 t

" 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 ",

Job Summary: We are looking for an experienced professional to manage and validate GxP computerized systems in a regulated pharmaceutical environment. The ideal candidate will play a key role in ensuring IT compliance with industry regulations and supporting core Quality Management System activities. Key Responsibilities: Installation and configuration of operating systems and other applications Diagnosing and troubleshooting of computer system and software problems Maintain an inventory of GxP computerized systems. Preparation and implementation of all the IT procedures as per GMP requirements. Responsible for Electronic data backup, archival and restoration. Verification of daily backup for electronic data generated for instruments. User management (Creation / modification of User IDs and passwords, assigning privileges) for laboratory and GMP Softwares. Developing the validation deliverables for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Preparation, execution and reporting of GxP computerized systems validation deliverables Maintain the validated state of all GxP computerized systems Conduct periodic reviews of all GxP computerized systems to ensure continued compliance. Manage QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs. Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance. Good knowledge of GMP, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity requirements for Pharma Required Skills & Experience: 3-4 years in Pharma industry Strong working knowledge of GMP, 21 CFR Part 11, Annex 11, and GAMP 5 Hands-on experience in validation of GxP systems within a pharma or life sciences setup Solid understanding of pharmaceutical regulatory and compliance frameworks Educational Qualification: M.Sc / B.E / B.Tech / MCA (with relevant industry experience)

About Apotex Inc. 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 To ensure planning and monitoring of analytical activities, Instrument Calibration / Qualification, Investigations and Documentation as per the procedure in Quality control at Apotex Research Pvt. Ltd. Job Responsibilities Report to Head of Quality & Compliance regarding day to day activities to Head, Quality Control. Ensure the operations in Quality Control Laboratory as per the established standard procedure. Identify the departmental employees training needs and to fulfil the same. Provide support to Manufacturing Operations during the execution of exhibit batches / commercial batches within the stipulated time line. Assess, review, approval and ensure the timely completion of the changes in QC department as per established & approved change control procedure. Ensure timely completion of analysis of commercial samples. Ensure smooth functioning of all laboratory instruments in co-ordination with service engineers. Responsible for reviewing and approval SOP s and directions for testing of laboratory samples in QC. Perform all work in accordance with all established regulatory and compliance and safety requirements. Conduct investigation for OOS / OOT results, and to identify assignable cause wherever applicable and to ensure timely completion of laboratory analytical investigations. Evaluation of Investigation, Deviations, CAPA and Change Control Records and approval as Manager Approval . Ensure a disciplined work environment and to provide expertise to subordinate \ colleagues in proper performance of laboratory procedures. Interact with QA department / Auditor during inspections or any audit conducted by regulatory authorities. Assist Quality group in various activities like data compilation for APQR, Training, Vendor development programme, Self-inspection and External audit programme. Participate in handling of Market complaints / Product recalls / Quality related returns (if any) in co-ordination with Quality group at Apotex affiliates and responding the same if required. Ensure to update (self) with latest cGMP / GLP / Regulatory requirements and to train the same to the departmental people. Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees. Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Collaboration, Courage, Perseverance and Passion. Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures. Take up any other work allotted by seniors and to fulfil the same. Job Requirements Education Minimum MSc /B Pharma or any equivalent degree. Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonnel skills. Proficient in MS office tools. Knowledge on preparation and review of various documents like SOPs, formats, protocols, reports and analytical data etc. Knowledge on investigation and deviation report preparation. Having good command on trouble shooting on instrument and analysis. Having well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities. Able to priortise the task, best in effective planning of work activities to meet the timelines. Experience Minimum 16 to 20+ years of experience in GMP regulated 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.

About Apotex Inc. 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 To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures. Job Responsibilities Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation. Approval of layouts, yearly & monthly schedules, to be added planners. SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements. Assess change controls related facility, equipment, process, utility, cleaning and packaging. Review & approve of standard operating procedures. Co-ordination and implementation of training activities of team members. Responsible for review of site VMP s (Validation Master Plan) and related documents. Responsible for review and approval of process validation & cleaning validation protcolsand reports. Co-ordinate with cross functional teams in Investigations carried out at ARPL. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion, Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned as per the expertise in the relevant subject. Job Requirements Education Minimum Bachelor of Pharmacy/ Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in Qualification and Validation of Equipment, Facility, Utilities, Process and Cleaning Maintains good Interpersonal skills and communication skills. Strives to drive projects related to Validations & Engineering effectively. Experience Minimum 12 - 15 years of experience in GMP Regulated 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.