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2.0 - 5.0 years
4 - 7 Lacs
Aurangabad
Work from Office
Job Description Review of various quality system documents. Preparation and review of Standard Operating Procedures. Preparation and review of Annual product quality review reports. Handling of QAMS activities like change control, OOS, OOT, Deviations, Lab Incidences and CAPA etc. Preparation and review of quality risk management. Review of batch manufacturing record and batch packing records. Preparation and review of Standard Operating Procedures. Review, assessment and closure of other QAMS documents whenever required. Issuance and retrieval of SOP, various list, protocols and logbooks etc. Maintain all cGMP records. Management of control sample area. Review of validation and qualification documents. Work Experience 2-5 years Education Graduation in Pharmacy Competencies
Posted 1 month ago
3.0 - 5.0 years
5 - 7 Lacs
Hyderabad
Work from Office
Summary The Regulatory Coordinator (RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments. To maximize operational effectiveness, collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects. . About the Role Key Responsibilities Ensure procurement of various key regulatory components (e. g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions word wide (as per health authority requirements). For new submissions - Represents Regulatory Affairs LCM BOE team in in NTO project team meetings, RA global and regional team meetings. Organize regulatory readiness with relevant line functions and with Country Organizations & Regions for timely delivery of submission and approvals Track progress of assigned projects, including timelines and dossier deliveries. Ensure quality and compliance with global regulatory requirements, countries requirements and adherence to regulatory internal policies and processes Support for maintaining country requirement lists and conducting need-based surveys & interaction with country organizations. Contribute to non-project related initiatives and excellence activities Support lessons learned sessions and trainings within and external to RA GDD leading to improve strategies and decisions on common regulatory approaches. Minimum Requirements: Degree in Science (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Minimum of 3-5 years of experience in R egulatory A ffairs, related areas of the pharmaceutical Industry Good interpersonal and communication skills Ability to plan and prioritize work Ability to work effectively in a matrix environment Fluency in English written and spoken Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation 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:
Posted 1 month ago
3.0 - 5.0 years
5 - 7 Lacs
Bengaluru
Work from Office
At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and our enterprise. Making animals lives better makes life better join our team today! Company Overview: At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet, and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals lives better makes life better join our team today! Your Role: [Associate/ Senior Associate Manager Aggregate Report Writing] As an Associate/ Senior Associate Manager Aggregate Report Writing, you will be part of Global Pharmacovigilance team to deliver veterinary pharmacovigilance documents for regulatory submission and internal use. The purpose of this role is to ensure the provision of comprehensive, high quality, scientifically accurate and consistent medical information in consultation with the Global Pharmacovigilance team. Your Responsibilities: Author/review of routine regulatory documents including, but not limited to aggregate reports (PSURs, PDER), Annual Signal Management Reports, and literature searches and occasionally other regulatory documents such as Risk Management Plan, Benefit-Risk Evaluation reports and Ad hoc PSURs required in accordance with applicable regulatory requirements. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Support Regulatory Affairs team in the timely submission of Regulatory dossier for the initial or renewal of product registrations. Maintaining and completing Veeva Vault RIM tasks on time. Collaborate with regulatory affairs, quality assurance, and clinical teams to gather relevant data and ensure consistency. Liaise with global affiliates, and regulatory authorities when necessary. Ensure documentation and processes are audit-ready and support regulatory inspections when applicable. Participate in training and continuous improvement activities related to pharmacovigilance and PSUR processes. What You Need to Succeed (minimum qualifications): Education : i. e. Graduation in veterinary medicine/ post-graduation in pharmacy or any other life science background. Experience : A minimum of 3 - 5 years of industry experience in PV or medical writing. Excellent oral and written communication skills with ability to communicate logically and technically with global stakeholders. High competency in Microsoft Office applications. In-depth knowledge of GxP requirements and regulatory guidelines with sound understanding of operational Regulatory and R&D principles. What will give you a competitive edge (preferred qualifications): Ability to work independently or as part of a team and collaborate with global teams cross geographies and time zones. Experience with electronic document management systems (e. g. , Veeva Vault), Mastery of templates, styles, and submission-ready formatting. Additional Information: Travel percentage up to 10%, annually. Location: IN, Bangalore - Hybrid Work Environment Don t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but dont necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Posted 1 month ago
6.0 - 10.0 years
8 - 12 Lacs
Mumbai
Work from Office
Job Description Drive Six Sigma molecules program & Continuous improvement projects at all API sites Monitor the process of six sigma projects across all sites and ensure action closure To co-ordinate and interact with functional departments for the smooth execution of projects Provide technical guidance, support and oversight to trouble shooting issues to site team Ensure sustenance of closed projects and knowledge management Explore & initiate Automation, Digitalization across sites wherever necessary for business Support capability improvements by deploying specialist scientific and technical competence Work Experience 6 to 10 Years Education Graduation in Chemical Engineering Post Graduation in Pharmacy or Chemistry Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management
Posted 1 month ago
7.0 - 9.0 years
9 - 11 Lacs
Bengaluru
Work from Office
Regulatory Affairs Associate III, Labeling, Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate III, Labeling, Labeling Who we are The opportunity The RA Associate III is responsible for preparing and/or reviewing high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. The candidate must demonstrate the ability to work independently and possess a strong knowledge of US FDA labeling regulations and guidance documents, applying this knowledge effectively across all work output. Additionally, they will be responsible for creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes. How you ll spend your day Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and for early development projects requiring a human factor or comparative analysis study to ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents documents with all relevant departments. Develop labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serve as a Subject Matter Expert (SME) in all facets of SPL/drug listing, including but not limited to finished product, bulk, and manufacturer under contract. The SME must be able to provide guidance to other team members related to established SPL documents (content and data elements) to ensure alignment with associated applications and applicable FDA regulations and guidance, as well as troubleshoot any validation errors received. Work closely with the SPL Vendor, as well as the FDA Drug Listing team, on any drug listing issues, ensuring a rapid resolution. Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes but is not limited to the development of side-by-side comparisons, SPL, and other required submission materials, as necessary. Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT. Work closely with external departments, including the CMC and Device teams, to align with internal product/device strategy and processes. Work closely with Regulatory Operations, as well as in Teva s publishing software, to ensure assigned projects are submitted on time following the eCTD requirements related to labeling. Support products falling under Business Development deals, if required, from a labeling/artwork and drug listing perspective. Attend assigned project meetings to ensure labeling timelines are met. Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects. Provide support to the Manager, as needed, in completing the year-end FDA Mandated Blanket No Change certification. This ensures all drug product listings remain active within the agencys National Drug Code (NDC) Directory, preventing potential issues such as disruptions in the market, Medicaid rebates, and other regulatory complications. Assist in the training of new labeling personnel. Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling and drug listing. Work in a team environment. Perform all other job-related duties as required by management and dictated by process changes. Your experience and qualifications 7-9 years experience in the Pharmaceutical Industry. Min 6+ years of RA experience will be preferred in the respective Markets. Bachelors in Pharmacy/Master in Pharmacy/Master in science & Life sciences Be able to multi-task in a fast-paced work environment. Have exemplary oral and written communication skills. Be organized with a keen attention to detail. Manage projects from initiation to completion. Collaborate effectively with cross-functional teams and team members to achieve project goals. Possess in-depth knowledge of US FDA regulations and guidance documents related to US Gx labeling and drug listing. Possess in-depth knowledge of US FDA eCTD submission standards and demonstrate experience in applying these requirements to routine labeling submissions. Proficiency with PC and Microsoft Office Suite, including Microsoft Word and Microsoft Excel. Thorough knowledge of Structured Product Labeling software. Proficiency in Adobe Acrobat Professional is a must. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Posted 1 month ago
8.0 - 12.0 years
25 - 30 Lacs
Mumbai
Work from Office
The Site Care Partner is a key Pfizer point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through site activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level recruitment and accountable for safeguarding the quality and patient safety at the investigator site. The Site Care Partner contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Pfizer pipeline opportunities under supervision. The Site Care Partner is accountable for ensuring that sites receive necessary support and engagement, that issues are resolved, and Pfizer s reputation is upheld throughout study lifecycle. Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study sites (eg. CRA, Investigator Contracts Lead, Site Activation Partner, cSOM, Clinician, etc. ) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. The Site Care Partner is responsible for site quality utilizing and interpreting data from analytic tools (eg SQRD), in conjunction with country intelligence and IRMS to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. Job Responsibilities: Accountable for site start-up and activation Deploy GSSO site strategies by qualifying and activating assigned sites Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection. Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision. Maintain a knowledge of assigned protocols Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation. Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e. g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc. ) Support country specific ICD review and deployment up to Site Activation Ensure follow up activity completion post PTA and SIV to ensure site readiness for FSFV Partners with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visit Responsible for relationship building and operational quality of the site Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners Ability to write scientific summary documents for Subject expert committee and present to the SEC in India and defend protocols. Have a scientific outlook to coordinate with local Medical affairs, Regulatory and Local Commercial teams for global and local studies. Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e. g. , vendor, site contracts and payment issues etc. ) Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly Responsible with site monitor/CRA for enrollment delivery during study conduct Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry up to Site Activation Accountable for study conduct and close-out Review Site Reports and related issues Assure quality and consistency in the delivery of monitoring Support the CRA/site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management. Responsible for proactively providing local intelligence. Provide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics. Provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies. QUALIFICATIONS / SKILLS Education Graduate or Post-Graduate in Pharmacy or Biotechnology or Nursing degree. MBBS/MD or in a related field with 8 - 12 years of experience Proficiency in local language preferred. English is required. Experience Demonstrated experience in Site Management with prior experience as a Site Monitor/CRA Demonstrated experience in Startup activities through to Site Activation Demonstrated experience in conduct and close out activities Demonstrated knowledge of Quality and Regulatory requirements in applicable countries Skills and Technical Competencies Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Good communication, presentation, and interpersonal skills Ability to manage required travel Demonstrated networking and relationship building skills Demonstrated ability to manage cross functional relationships Ability to communicate effectively and appropriately with internal & external stakeholders Ability to adapt to changing technologies and processes Knowledge of country requirements for GCP that may be different to those of Pfizer Procedures Behavioral Competencies Effectively overcoming barriers encountered during the implementation of new processes and systems Identifies and builds effective relationships with investigator site staff and other stakeholders Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization Able to manage issues that are escalated by site staff in a way that meets the needs of both Pfizer and the site staff Organizational Relationships: Direct Report to DCSO Indirect relationships with: Global Study Manager/Study Operations Manager Start Up PM SAP CTA CTRO ICL Site Monitor/CRA Feasibility Strategy and Analytics Lead Signal Interpretation Lead Coordinates with institutions and investigators at the country level. Travel - As needed nationally and internationally. Medical #LI-PFE
Posted 1 month ago
8.0 - 13.0 years
30 - 35 Lacs
Mumbai
Work from Office
Mumbai, India (hybrid role: 3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed, and detail-oriented pharmacovigilance professional with 8+ years of total PV experience, including a minimum of 4-5 years in authoring aggregate safety reports and Risk Management Plans (RMPs) and have additional experience overseeing ICSR compliance activities at both local and global levels, then we would love to hear from you. Join us to help improve peoples lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are: We act decisively but we never compromise on quality. We keep our promises and do as we say. We value our heritage and foster an entrepreneurial spirit. We reinvest in our future - in our products, our brands and our people. We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovias therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. Main responsibilities & duties: Prepare and author aggregate safety reports and regulatory documents, including PADERs, Summary Evaluation Reports (SERs), and Serious Adverse Reaction (SAR) reports Prepare and author Risk Management Plans (RMPs) Provide strategic oversight and operational management of SDEAs, including authoring, reviewing, and ensuring ongoing compliance Ensure compliance with ICSR submission timelines and partner obligations Develop and maintain internal processes to support core pharmacovigilance activities Support and participate in pharmacovigilance audits and regulatory inspections Contribute to product labelling activities based on safety data and evolving benefit-risk profiles Monitor and assess regulatory intelligence updates and implement necessary changes to PV systems and practices Assist with pharmacovigilance risk assessments and due diligence activities for new products or partnerships Develop, track, and report key performance indicators (KPIs) to senior leadership for informed decision-making Collaborate cross-functionally with internal leadership teams to ensure PV oversight aligns with broader business goals About you: Candidates with progressive pharmacovigilance experience, specifically in authoring aggregrate reports, RMPs, as well as management and oversight of SDEAs and ICSR compliance activities, should have the skills and experience required for the role. We are also looking for: Bachelors degree in Pharmacy (Masters degree desirable) 8+ years of experience in pharmacovigilance with minimum 4-5 years of experience in authoring aggregate reports/RMPs is essential. Experience in working with core pharmaceutical companies desirable Strong knowledge of PV regulations at local and global level Experience in management of SDEAs Experience in ICSR review and compliance monitoring Organised and inquisitive, with problem solving skills Solid time management skills, the ability to multitask and see the big picture Strong technical skills Adaptability and resilience What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working. By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible. Enter Your Details Please fill out all form fields and upload your CV If you would like to know more about Ortolan People and how we can help you reduce your ongoing recruitment costs, get in touch! Hope started operating in 2013 and we had a lot of positions that we needed to fill. We initially relied on recruitment agencies and did a little bit of our own direct advertising, but wanted to explore more cost effective recruitment methods. We decided to try some e-recruiters to see how they could help. Ortolan were by far the best and also the most cost effective of the suppliers that we tried and we now ask for their help with virtually all of our external recruitment needs, because they provide a very personal and tailored service, have people, rather than computers, working on their candidate searches and short lists. Using Ortolan has significantly reduced our expenditure on attracting candidates, but has also meant that we have had a much broader range of people applying to work for us than before. I d highly recommend trying Ortolan to see how they can help you. Peter Spargo, HR Manager, Hope Construction Materials Ltd Nick Benson Chief Executive I am a solicitor who as well as having had a 10 year career as a British Army officer has also run a number of successful businesses. I have worked in large law firms, small start-up businesses and have been the CEO of a NASDAQ listed international leisure company. Drawing on this broad base of experience I co-founded Ortolan Group in 2007, driven by the opportunity to provide innovative and high quality recruitment services at a sensible price point. Today I help to manage the business and also spend a lot of time working as a solicitor with our sister company, Ortolan Legal. Because of my background, I tend to lead on all of our legal recruitment work. I occupy my spare time raising Tamworth pigs and flying. Cindy Parry Senior Consultant Having spent most of my working life in Recruitment and HR, I sold my successful Recruitment Business in 2009 to a large national High Street agency. Having missed the recruitment industry too much to stay away! I joined Ortolan in 2013 and I now head up their Permanent Recruitment Division. I live in Cheshire with my husband and unruly pack of 4 very large dogs, and as I don t work Mondays love to spend long weekends out and about in the countryside with the dogs, and ever so occasionally shopping for handbags and shoes! Jane Johnstone Senior Consultant After attaining an engineering degree and working for British Gas designing distribution systems, I had a change of career and joined British Aerospace as a computer programmer. I then spent twenty years working for major IT solutions vendors in a range of roles (product and sales support, professional services, technical management), before I had my next change of career into recruitment in 2008, when I moved from South East to Derbyshire. In my spare time I like to explore the Peak District, then reward myself with a pub lunch!
Posted 1 month ago
15.0 - 20.0 years
50 - 60 Lacs
Nagpur
Work from Office
Job Description To coordinate with research and Development / Plant for technology transfer execution of exhibit batches, launch products and validation batches. To coordinate with purchase department for availability of all raw materials to ensure smooth execution of trial bathes, scale up batches, Exhibit batches & Pre-validation batches. Design and approval of documents related to manufacturing of scale up batches, exhibit batches, validation batches and commercial batches and support to execution. To conduct the process validation of the product. To support site-regulatory affairs in timely filing of exhibit products/ Variation batches. To assist plant in regulatory inspection of customers and regulatory agencies. To conduct technology transfer of products from other locations to Nagpur plant and vice versa. Carrying out self-inspection and review of self-inspection reports. Complete self-training and monitor training of team members on the relevant SOP s. To perform the OOS/OOE investigation for the batch failure and to find out the root cause. Implementation of CAPA to prevent recurrence of failure. Supervise compliance to all cGMP or any other regulatory requirements, including EH&S requirements. Report any quality concerns or suggestions for improvements to product and process to superior. Execute and supervise all tasks and activities as per the applicable SOP s. Handling of QAMS and SAP systems as per requirement and given role. Review and approval of document pertaining to PDL and support to PDL related activities. Preparation and review of functional procedures (SOP s) and related documentation activities for Corporate Technology Transfer Function. Work Experience Candidate must be M Pharma with total experience of 15 to 20 years in Process Development / Technology Transfer /MS&T Education Graduation in Pharmacy Masters in Pharmacy Competencies Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation
Posted 1 month ago
0.0 - 5.0 years
1 - 3 Lacs
Pune
Work from Office
Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.
Posted 1 month ago
1.0 - 4.0 years
2 - 3 Lacs
Jodhpur
Work from Office
About Company ASG Eye Hospitals is a chain of super specialty eye hospitals in India. It offers a comprehensive range of eye care services including treatment and surgeries of Retina, Cataract, Squint, Oculoplasty, Cornea, Lasik, ICL, Glaucoma, and Paediatric Ophthalmology. Currently, the group has 165+ Eye Hospitals across 83+ cities in India. Role - Executive - Pharmacist Location - Jodhpur Job Responsibilities Provide advice about health issues, symptoms and medications in response to customer enquiries. Process prescriptions and dispense correct medication. Ordering, selling and controlling medicines and other stock. Manage inventory to ensure an adequate supply of medications. Managing budgets Keeping statistical and financial records Preparing publicity materials and displays Counsel patients on proper medication and side effects. Desired Candidate Profile D.Pharm / B.Pharm Must be a registered Pharmacist from the State Pharmacy Council. Good Communication Skills. Must have Basic computer knowledge. Perks and Benefits + Performance Based Incentives Interested candidates mail your resume along with below details to simran.meena@asgeyehospital.com or WhatsApp the same on 88750 29935 Total Experience - Current CTC - Expected CTC - Notice Period -
Posted 1 month ago
0.0 - 5.0 years
1 - 2 Lacs
Hyderabad
Work from Office
We Are Hiring! We are looking for Pharmacist for our retail outlets across Hyderabad. Only Telangana state candidates with Telangana state PCI were eligible for this position. Job Responsibilities : Knowledge about medicines Reading prescriptions Be able to suggest medicines for basic ailments Suggest alternate me dicine if one brand is not available Basic Computer knowledge Manage invoicing and billing Qualification: *For Pharmacist: D. PHARM / B.PHARM / M.PHARM with Telangana State PCI Registration *For Pharmacy Assistant: SSC & above with at least 2+ years of retail pharmacy experience *For Pharmacy Trainee: Freshers with SSC & Above *Experience: Freshers / 0 to 10 years of relevant pharmacy retail experience Skills Required: Knowledge of medicines (drugs), commitment to serve the community & good interpersonal skills. Why to Join Apollo Pharmacy? Largest organized Pharmacy retail chain in India Continuous Learning & Development Transparent Career Path Rewards & Recognition Attractive Compensation & Benefits 1 Weekly off & Holidays Casual, Sick & Earned leaves PF & ESI Monthly Incentives NOTE: Eligibility for candidates with D. Pharm / B.Pharm / M.Pharm qualification with valid PCI License ONLY. Incase awaiting for PCI License apply for "Trainee Pharmacist" role on https://careers.apollopharmacy.app Venue : Gate No.7, 1st Floor, Block -A, General Hospital, Pharmacy HR Dept, Apollo Health City Campus, Jubilee Hills, Film Nagar, Hyderabad Google Map: https://goo.gl/maps/VgeX9SbvNnL2 Contact Details: Chilam Praveen Kumar- 9177962210
Posted 1 month ago
0.0 - 5.0 years
1 - 3 Lacs
Madhyapradesh, Gujarat, Rajasthan
Work from Office
About Us :- Indira IVF centre is the pioneer in providing affordable yet creditable infertility curation to the common people for the first time in India. It is armed with the state-of-the-art infrastructure, advanced equipments and a pool of renowned physicians. We started with a two room clinic back in 1988 and today we stand tall as one of the most esteemed and prestigious IVF service providers in the country and beyond. Job Description :- Issue & Return of Material against Patient indents from Stores and against Departmental indents Direct Issue of drugs/ medical consumable to Patient Issue of Narcotics as per protocols Receiving the material at Receiving Bay & Processing of Invoices Emergency Cash Purchase Receipt of consignment goods & Processing their Invoices on Consumption Physical Stock Verification. Only immediate joiners apply for the role Interested candidates can share their profile on manali.yadav@indiraivf.in
Posted 1 month ago
2.0 - 7.0 years
2 - 5 Lacs
Greater Noida
Work from Office
Urgent requirement Pharmacist / Senior Pharmacist - Sharda Healthcity Pharmacy SHARDA HEALTHCITY- PHARMACY Designation: Pharmacist / Senior Pharmacist r Department: Pharmacy Number of Openings: Pharmacist - 12 and Senior Pharmacist - 8 (Vacancies) Qualification: 10th or 12th or Any Graduation Salary Range CTC: For Pharmacist - 17,000 to 28,000 Monthly CTC (Depends on Experience & Interview with us) For Senior Pharmacist - 28,000 to 40,000 Monthly CTC (Depends on Experience & Interview with us) Job Profile: - 1. To dispense the medication to the patients. 2. To check the medication as per the billing made by operator and handover to the cashier for further process. 3. To maintain the register in case of shortage of medicine and new products 4. To maintain the schedule and record on software. 3. To monitor the temperature and update the temperature monitor checklist on daily basis. 6. To check and remove th expiry from the rack. 7. To check and ensure the cut strip stock. 8. To check for dispensing error. 9. To maintain the drug recall record on every month. 10. To check vendor supply 11. To maintain and record for IP patients 12. To maintain the inventory 13. To maintain LASA/High risk medication. Interview Location: - Contact: Nishant Chaudhary- 9311211527 (Whatsapp Available) SHARDA HOSPITAL- Building, Entry from gate number- 2 First floor, C-Block, HR Department, Greater Noida, Uttar Pradesh 201310 Interested candidates can share their profiles via email at nishant.kumar7@sharda.ac.in or Contact Number:- 9311211527 (WhatsApp available) for further inquiries We look forward to welcoming passionate individuals to our team as we embark on this exciting journey in healthcare excellence Regards, Nishant Chaudhary Assistant Manager- HR Human Resources Department
Posted 1 month ago
0.0 - 5.0 years
1 - 3 Lacs
MADHYAPRADESH, GUJARAT, Rajasthan
Work from Office
Job Description :- Clinical Work Provide direct & indirect patient care in emergency care situations. Provide any & every detail about the procedures, medications, and answer patient queries & subsequent follow-up. Reporting & documenting USG findings/treatment plan in File/Portal. Documenting the prescribed mediation/Stimulation/HRT drugs etc. & in file/portal/ providing Trigger time. Executing all Donor Related Activity, in association with Donor Coordinator. Administer injection to patient/donor, as prescribed in file. Maintain stock of all required injections/drugs. Elicit accurate & relevant patient/donor medical history Co-ordinate procurement of necessary documents from patient/donor, per PCPNDT regulations. Update all patient records in both physical, as well as digital format. File all regulatory forms/consents before each procedure. Submit PCPNDT forms timely, as required by PCPNDT office. Identify & provide for physical, emotional, and developmental needs of patients. Counsel patients & their families; explain procedures planned for them. Ensure all procedures are carried out as per the SOP, and are compliant with the Policies on Universal Protection, Biomedical Hazard & Infection Control. Should have valid state registration Only immediate joiners apply for the role Interested candidates can share their resume on manali.yadav@indiraivf.in
Posted 1 month ago
0.0 - 3.0 years
2 - 3 Lacs
Hyderabad
Work from Office
We Are Hiring! We are looking for Pharmacist for our retail outlets across Hyderabad. Only Telangana state candidates with Telangana state PCI were eligible for this position. Job Responsibilities : Knowledge about medicines Reading prescriptions Be able to suggest medicines for basic ailments Suggest alternate me dicine if one brand is not available Basic Computer knowledge Manage invoicing and billing Qualification: *For Pharmacist: D. PHARM / B.PHARM / M.PHARM with Telangana State PCI Registration *For Pharmacy Assistant: SSC & above with at least 3+ years of retail pharmacy experience *For Pharmacy Trainee: Freshers with SSC & Above *Experience: Freshers / 0 to 10 years of relevant pharmacy retail experience Skills Required: Knowledge of medicines (drugs), commitment to serve the community & good interpersonal skills. Why to Join Apollo Pharmacy? Largest organized Pharmacy retail chain in India Continuous Learning & Development Transparent Career Path Rewards & Recognition Attractive Compensation & Benefits 1 Weekly off & Holidays Casual, Sick & Earned leaves PF & ESI Monthly Incentives NOTE: Eligibility for candidates with D. Pharm / B.Pharm / M.Pharm qualification with valid PCI License ONLY. Incase awaiting for PCI License apply for "Trainee Pharmacist" role on https://careers.apollopharmacy.app Work Locations: Hyderabad . Area: Khajaguda, Hitech City, Nallagandla, Tellapur, kondapur, kukatpally, Gopanpally, Osman Nagar, Nanakramguda & Kokapet. Venue : Gate No.7, 1st Floor, Block -A, General Hospital, Pharmacy HR Dept, Apollo Health City Campus, Jubilee Hills, Film Nagar, Hyderabad Google Map: https://goo.gl/maps/VgeX9SbvNnL2 Contact Details: Chilam Praveen Kumar- 9177962210
Posted 1 month ago
1.0 - 3.0 years
0 - 0 Lacs
delhi, gurugram
On-site
Roles & Responsibilities: 1. Create MOU with the corporate hospitals and big hospitals for outsourcing of Infectious disease specialty samples to Infexn Laboratories. 2. Meet specialist doctors like BMT Specialist, Oncologists, ID specialists, Intensivists, Chest Physicians, General Physicians, Neurologists, Paediatricians, Gastroenterologists, Neonatologists, Gynaecologists, Ophthalmologist, etc. and promote relevant tests from our menu and get business from them. 3. Create KOLs and KBLs for the company and for specific tests. 4. To keep the doctors engaged by following up regularly and by passing on new tests and technology information. 5. Being alert to the competition and collecting the available competitor information and passing it on to the seniors and marketing department. 6. Handling a MSL list of 60 clients/250 doctors efficiently and making sure that at least 25 to 30 regular prescribers are there in the list. 7. 3 to 4 new conversions of doctors per month are expected. Further ensuring continuous business from them. 8. Should be able to analyse and create additional revenue from the existing clients. 9. Should have a sharp ability to convert and demand business from doctors. 10. Launch new tests to Hospitals and doctors. Give test information to the hospital lab by meeting the Lab HOD and relevant person to ensure the smooth functioning of the sample outsource. 11. Responsible for monitoring and increasing channel partners business in the given territory. Also ensure that the monthly sales review meetings are attended by the channel partners. 12. Coordinate with Channel partner sales personnel and maximize sales. 13. A minimum of 1 to 2 days working every month in the channel partners territory is must to ensure proper sales monitoring, support and to resolve channel partners queries, if any. 14. Minimum 10 meetings per day are mandatory. 15. Exhibit thorough professionalism during working hours and to the clients while interacting on the phone and in person. 16. Punching Attendance and meetings check-ins in the software is mandatory. 17. Prepare the required presentations in the given formats for the weekly meetings. 18. Timely and proper reporting to the manager is mandatory. Educational qualifications Graduate/Postgraduate from reputed institution preferably in science with Microbiology, biotechnology, biochemistry, and molecular biology as major subjects. B. tech/M. tech from reputed institution. B. Pharm/ M Pharm from reputed institution. MBA or post grad management diploma/degree in sales and marketing can be preferred. Work Experience 1. Minimum 1 experience of hospital working and meeting the doctors. 2. Experience in Pharma selling to the specialists will be advantageous. Work experience of selling antibiotics and speciality drugs to the clinicians will be advantageous. 3. Fresher with inclination to sales can be considered for the position of Sales trainee. Personality Traits: 1. Should have flair for sales and marketing 2. Should have a pleasant personality 3. Should be comfortable in doctors cabin and able to communicate confidently with the doctors 4. Should be ambitious and have a passion to succeed in whatever he does in life. 5. Should be result and target driven. 6. Should be self-motivated to work irrespective of monitoring 7. Should have a willingness to learn and acquire knowledge of the subject and selling. 8. Should be a team player. Website: http://www.infexn.in/index.html
Posted 1 month ago
0.0 - 5.0 years
12 - 14 Lacs
Kamrup
Work from Office
Responsibilities: * Dispense medications accurately * Collaborate with healthcare team * Provide patient education on medication use * Maintain inventory levels * Ensure compliance with regulatory standards D. Pharm or B. Pharm pass only. Sales incentives Annual bonus
Posted 1 month ago
4.0 - 7.0 years
1 - 3 Lacs
Bengaluru
Work from Office
Responsibilities: * Dispense medications accurately * Assist with inventory management * Provide exceptional customer service * Collaborate with healthcare team * Follow pharmacy policies & procedures Provident fund Health insurance Employee state insurance
Posted 1 month ago
0.0 - 2.0 years
0 - 1 Lacs
Mohali
Work from Office
We are looking for Staff for our Mohali Branch in Phase 10, Sector 64. Job role would be flexible which includes. Reception work, Pharmacy work , Tele Calling. We will give you training for all the departments.
Posted 1 month ago
1.0 - 4.0 years
2 - 3 Lacs
Ahmedabad
Work from Office
Receiving indents. Dispatching medicine to inpatient. Attending outpatient. Receiving Medicine from the supplier. Arranging medicine according to their storage condition. Purchase return of medicine due to their expiry date. Handling narcotic & keep record of it. Arranging non-available medicine from nearby chemist. Hand over cash to cashier. To Internalizing the S.O.P. Selection of good quality product. To receive the quotation from different company. As per doctor requirements check the comparative rates. Procurement of medicine. Negotiation for scheme with supplier/manufacture.. Purchase order approval. Attending the M.R. for new molecule & new brand. Audit of medicines for their expiry & storage condition. Training programmed on medication safety for concerned staff. Assisting assistant pharmacist in routine work whenever required. Second check on gate pass. Physical stock taking of medicine quarterly & Whenever Require. To take rounds in the Wards to check for the Compliance. Assess the identity, strength and purity of medications. Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability. Provide information and advice regarding drug interactions, side effects, dosage and proper medication storage. Analyze prescribing trends to monitor patient compliance and to prevent excessive usage or harmful interactions. Order and purchase pharmaceutical supplies, medical supplies, and drugs, maintaining stock and storing and handling it properly. Maintain records, such as pharmacy files, patient profiles, charge system files, inventories, control records for radioactive nuclei, and registries of poisons, narcotics, and controlled drugs.
Posted 1 month ago
7.0 - 13.0 years
0 Lacs
hyderabad, telangana
On-site
You will be joining USP's Global Biologics department as a Sr. Scientist - I (RSS-Review), where you will play a crucial role in supporting the development of USP documentary standards and reference standards for biological products. In this hands-on, non-supervisory position, you will be responsible for ensuring the accuracy, clarity, and compliance of scientific documents, managing the reference standard stability program, and driving continuous process improvements. Your primary responsibilities will include performing technical and quality reviews of documents, developing and reviewing SOPs and training materials, assisting in investigations of quality-related issues, and collaborating with internal stakeholders to develop new standards for analytical analysis of biological products. You will also be involved in maintaining the reference standard stability program, reviewing testing data, preparing stability trend reports, and updating databases to document laboratory data and program determinations. To succeed in this role, you must have a PhD degree in Biochemistry/Biology/Pharmacy or a related field with 7 to 10 years of experience, or a Master's degree with 11 to 13 years of experience. You should have demonstrated expertise in technical review of analytical documents in Quality Assurance and hands-on experience with analytical techniques for characterizing biological products. Strong communication skills, both written and verbal, along with the ability to work collaboratively with internal and external stakeholders, are essential for this position. Additionally, knowledge of USP products and services, experience in the pharmaceutical or biotechnology industry, and the ability to work effectively in a fast-paced environment are desired preferences. While there are no supervisory responsibilities associated with this role, you will be expected to take ownership of your work, ensure timely delivery of tasks, and maintain the highest quality standards. USP is committed to providing comprehensive benefits to protect the well-being of you and your family, including paid time off, healthcare options, and retirement savings. By joining USP, you will contribute to the organization's mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs.,
Posted 1 month ago
0.0 - 4.0 years
0 Lacs
delhi
On-site
The role of Medical Representative/Territory Manager in Delhi is a full-time on-site position with the main duty of promoting pharmaceutical products to healthcare professionals. You will be responsible for maintaining and developing relationships with doctors, pharmacists, and other key stakeholders, as well as achieving sales targets. Additionally, you will need to conduct market research, schedule appointments and meetings with healthcare staff, handle orders, and ensure the dissemination of product knowledge to enhance market penetration. To excel in this role, you should possess skills in Medical Sales and Customer Service, along with excellent communication abilities. A good knowledge of Medicine and Pharmacy is essential, as well as strong interpersonal and relationship management skills. Being self-motivated and capable of working independently are also key traits for this position. A Bachelor's degree in Pharmacy, Life Sciences, or a related field is required, while previous experience in a similar role would be advantageous.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
ranchi, jharkhand
On-site
As a Medical Sales Representative at SKM Enterprises in Ranchi, you will play a crucial role in promoting and selling medical products to healthcare professionals. Your responsibilities will include developing and maintaining customer relationships, providing product demonstrations, and ensuring high levels of customer satisfaction. Additionally, you will be tasked with achieving sales targets, managing product inventory, and offering valuable market feedback to the company. To excel in this position, you should possess strong medical sales skills along with excellent communication and customer service abilities. A solid knowledge of medicine and pharmacy is essential, and previous experience in the healthcare industry would be advantageous. You must also demonstrate strong interpersonal and relationship-building skills, the ability to work both independently and as part of a team, and hold a Bachelor's degree in a relevant field such as Pharmacy, Medicine, or Life Sciences. If you are a motivated professional with a passion for sales and a background in healthcare, we invite you to join our dynamic team at SKM Enterprises and make a meaningful impact in the medical products distribution sector.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
As a Product Manager at Hyuman, you will be part of a team that believes skincare is more than just science; it's about self-care, soul care, and smart innovation. Hyuman, a personal care brand dedicated to democratizing self-care for women, aims to make quality and intentional skincare easily accessible, empowering women to feel visible, celebrated, and self-assured in their skin. We are currently seeking a dedicated and enthusiastic R&D Analyst with practical expertise in formulation, procurement, and product development. If you have a passion for personal care and are excited about contributing to our mission, this opportunity is for you. This is an onsite position located in Dahisar, Mumbai. Your main responsibilities will include leading end-to-end product development, driving technology transfer from lab scale to full-scale manufacturing, collaborating with vendors, managing procurement, ensuring timely product launches, maintaining consistency and quality throughout the product lifecycle, troubleshooting manufacturing issues, supporting lab testing, assisting Quality Control, and fostering strong relationships with vendors, suppliers, and R&D collaborators. You will also be expected to identify opportunities for innovation and efficiency within the vendor network. To qualify for this role, you should hold a Bachelor's degree in cosmetology, Chemistry, Pharmacy, or a related field, and have at least 2-3 years of experience in the personal care, cosmetics, or beauty industry. A strong understanding of product development and brand vision is essential, along with excellent communication and stakeholder management skills. You should be comfortable making agile decisions and adept at multitasking across teams. Join us at Hyuman and be part of a team that is dedicated to transforming the skincare industry by prioritizing self-care, innovation, and inclusivity.,
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
pune, maharashtra
On-site
Optra Scan Pvt Ltd is a renowned provider of digital pathology solutions, transforming the landscape of pathology practices worldwide by streamlining the management and interpretation of diagnostic information. With our innovative technology, we empower pathologists to enhance efficiency, precision, and patient care through the integration of digitalization and artificial intelligence. As a Technical Writer - Regulatory at OptraSCAN, you will play a pivotal role in creating, organizing, and updating regulatory documentation essential for product approvals, certifications, and market entry across global jurisdictions. This position demands a blend of strategic regulatory planning and meticulous technical writing focused on ensuring adherence to international standards like ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulations. Your responsibilities will include preparing and managing various regulatory documents such as Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), Risk Management Files, Declarations of Conformity, and FDA submissions. Collaboration with cross-functional teams comprising R&D, QA, Clinical, and Marketing departments will be essential to gather inputs for the compilation of submission materials. In the realm of technical writing, you will be tasked with crafting, reviewing, and refining Standard Operating Procedures (SOPs), work instructions, user manuals, labeling, and Instructions for Use (IFUs) to ensure accuracy, clarity, and regulatory compliance. Your ability to translate intricate technical information into easily comprehensible documentation will be critical in this role. Staying abreast of regulatory updates such as EU MDR and FDA guidelines will be imperative to ensure that internal processes and documentation align with the latest standards. Compliance with key regulations like ISO 13485, ISO 14971, IEC 62304, IEC 60601, EU MDR 2017/745, and FDA 21 CFR Part 820 will be a focal point of your responsibilities. Moreover, you will provide support for internal audits and inspections by maintaining meticulous and readily accessible documentation. Assistance in Corrective and Preventive Actions (CAPA) documentation and post-market surveillance reporting will also be expected as part of your Quality System Support duties. To qualify for this role, you should hold a Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field, accompanied by at least 3-6 years of experience in regulatory writing or regulatory affairs within the medical device or healthcare product domain. Proficiency in global medical device regulatory frameworks, exceptional written English and technical writing skills, as well as strong organizational and project management capabilities are essential prerequisites. Preferred qualifications for this position include prior experience in preparing 510(k) submissions, CE Mark applications, or similar regulatory filings. Knowledge of digital pathology, imaging devices, or software as a medical device (SaMD) would be advantageous, along with a certification in Regulatory Affairs such as RAPS RAC. Join Optra Scan Pvt Ltd in revolutionizing the digital pathology landscape and leveraging your regulatory expertise to drive impactful advancements in healthcare technology.,
Posted 1 month ago
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