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5.0 - 9.0 years
0 Lacs
madurai, tamil nadu
On-site
As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to meet quality, cost, and delivery targets. You will develop and implement production schedules to ensure timely product delivery while ensuring adherence to Good Manufacturing Practices (GMP) and compliance with USFDA regulations. Your role will involve maintaining and ensuring compliance with USFDA, WHO, and other regulatory standards in all production processes. You will coordinate with the Quality Assurance (QA) team to prepare for and manage regulatory audits, inspections, and proper documentation of manufacturing processes. Leading, mentoring, and training the production team will be essential to ensure optimal performance and awareness of regulatory requirements. You will foster a culture of continuous improvement, accountability, and teamwork among the team members. Identifying and implementing process optimizations to improve productivity, efficiency, and quality will be part of your responsibilities. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain to resolve production-related issues is crucial. Additionally, you will be accountable for maintaining and calibrating production equipment and facilities, implementing safety protocols, managing inventory of raw materials, and preparing and managing the production budget to optimize costs without compromising quality. To qualify for this role, you should hold a Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field. A minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial role is required, along with proven experience in a USFDA-regulated environment. Knowledge of cGMP, CAPA, and regulatory submissions is essential. Your technical and functional skills should include a strong understanding of pharmaceutical production processes, familiarity with validation protocols, exceptional leadership, communication, and interpersonal skills, strong analytical and problem-solving abilities, and the ability to work under pressure and meet tight deadlines.,
Posted 4 days ago
5.0 - 7.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.
Posted 6 days ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
You will be part of the Formulation Development team, contributing your expertise in Biologic Formulations and pharmaceutical sciences. Your responsibilities will include conducting literature reviews, formulating biological products, designing and executing experiments, analyzing data using various techniques, calibrating instruments, performing proof-of-concept studies, conducting stability studies, writing scientific reports, and collaborating with cross-functional teams. To excel in this role, you should hold a minimum of a Postgraduate degree (MTech, MPharm) in Pharmaceutical Sciences, Chemistry, or a related field. Proficiency in analytical techniques like HPLC, GC, pH, Osmolality, KF, and UV spectroscopy is essential. Effective communication, strong analytical and research skills, teamwork abilities, and knowledge of pharmaceutical excipients and raw materials will be key to your success in this position.,
Posted 1 week ago
0.0 - 4.0 years
0 Lacs
patna, bihar
On-site
The role is a full-time on-site opportunity for a Student based in Patna. Your responsibilities will include participating in pharmaceutical studies, supporting professors and research teams in their projects, attending lectures and practical sessions, compiling research data, and contributing to academic publications and group discussions. Additionally, you will engage in laboratory work, ensuring compliance with safety protocols and academic regulations. To excel in this role, you should have an interest in Pharmaceutical Sciences and a strong willingness to learn. Collaborative skills and the ability to work effectively within a team are essential. Proficiency in research and data compilation, as well as familiarity with laboratory procedures and safety protocols, is required. Your organizational and time-management skills should be strong, and you should possess excellent communication and interpersonal abilities. While a Bachelor's degree in a relevant field is preferred, previous research or laboratory experience would be advantageous.,
Posted 1 week ago
0.0 - 4.0 years
0 Lacs
hyderabad, telangana
On-site
As a Pharmaceutical Intelligence Intern at pharmaand GmbH (pharma&), a global pharmaceutical company based in Vienna, Austria, you will have the opportunity to be a part of our team in Hyderabad. This full-time, 6-month internship will allow you to actively contribute to the commercial and analytical operations of pharma& in a meaningful manner. Your main responsibilities will include supporting forecasting models by utilizing both internal and external data, participating in market research activities such as surveys and treatment landscape analysis, conducting secondary research to gather competitive intelligence, working closely with commercial teams to monitor brand performance and aid in planning, assisting in CRM optimization in collaboration with cross-functional teams, contributing to various ad-hhoc projects alongside the analytics team, and keeping abreast of pharmaceutical market trends and regulatory developments. To qualify for this role, you should hold a Bachelors degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field. Strong analytical and communication skills are essential, and any prior internship or experience in the pharmaceutical industry would be advantageous. The ability to work effectively in a team environment is also crucial. In return, we offer you hands-on experience with real-world data and strategic initiatives, exposure to global commercial operations, mentorship, and opportunities for professional development. A monthly stipend will be provided, and you may also have the chance to support preparations for industry conferences, with travel expenses covered by pharma& if applicable. This internship is based in Hyderabad, India, and is a full-time, paid position lasting for 6 months. Monthly stipend will be provided based on candidate qualifications. Candidates must be legally eligible to work in India to be considered for this opportunity.,
Posted 1 week ago
0.0 - 4.0 years
0 Lacs
hyderabad, telangana
On-site
As a Pharmaceutical Intelligence Intern at pharmaand GmbH in Hyderabad, you will be an integral part of our team for a full-time, 6-month internship. Your role will involve supporting forecasting models, conducting market research, gathering competitive intelligence, tracking brand performance, contributing to CRM optimization, and assisting the analytics team on various ad-hoc projects. You will also be responsible for staying updated on pharmaceutical market trends and regulatory developments. To excel in this role, you should hold a Bachelors degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field. Strong analytical and communication skills are essential, and any prior internship or experience in the pharmaceutical industry would be advantageous. Your ability to work collaboratively in a team environment will be crucial for success in this position. This internship offers you the opportunity to gain hands-on experience with real-world data and strategic initiatives. You will be exposed to global commercial operations, receive mentorship, and have access to professional development opportunities. A monthly stipend will be provided, and you may also support preparation for industry conferences, with travel expenses covered by pharmaand GmbH if applicable. The position is located in Hyderabad, India, and is a full-time, paid internship lasting for 6 months. The monthly stipend provided will be based on your qualifications, and candidates must be legally eligible to work in India to be considered for this opportunity.,
Posted 2 weeks ago
4.0 - 7.0 years
8 - 13 Lacs
Pune, Gurugram, Bengaluru
Hybrid
Job Purpose Gathering, analyzing, and writing requirements, data analysis, report creation, system flow diagrams, PowerPoints, as well as assisting with project delivery of in-house/vendor application implementation. Work with cross-functional teams to understand the business to apply effective technical solutions for different work streams. Be highly self-motivated, forward-thinking and like to explore new ways of applying existing and new technologies to solve Business problems. Understand the importance of prioritizing according to business value and can communicate effectively with stakeholders. Have an innate interest in applying modern technology to the daily work. Desired Skills and experience Experience of working with Digital Teams in pharmaceutical organisations Understanding of Clinical operations process and Clinical feasibility process, with ability to drive all feasibility and site identification activities related discussions with business users Work with business stakeholders (like Clinical Ops Planning & Feasibility leads) to capture user goals, needs and expectations and translating these into personas, user-journeys & product features that drive towards improvements. Drive experience design activities to improve user interfaces and task flows through wireframing, prototyping and ideation workshops. Work with product managers/product owners to identify & define use-cases as well as write and prioritise user stories Work with UX designers, data engineers, data scientists, biostatisticians and technical architects to map dependencies, refine the requirements and render them ready for implementation Contribute to the production and continued refinement of business cases throughout the life cycle of the product Contribute to the wider Business analysis community of the project Experience in agile methodologies, especially agile business analysis Ability to work in a fast-paced and dynamic environment Detail-oriented, and able to manage multiple priorities simultaneously Understanding of data relating to clinical trial planning, management & deliveryRole & responsibilities
Posted 1 month ago
8.0 - 12.0 years
10 - 15 Lacs
Bengaluru
Work from Office
Althera Laboratories India private Limited is a leading OSD (Oral Solid Dosage) manufacturing company committed to developing and delivering innovative pharmaceutical products. We are seeking a highly motivated and experienced Clinical Project Manager to lead and oversee clinical trials for our drug development pipeline. Role & responsibilities Develop and execute comprehensive clinical project plans, timelines, and budgets in alignment with company objectives and regulatory requirements. Oversee all aspects of clinical trial conduct, including protocol development, site selection, investigator initiation, patient recruitment, data management, and safety monitoring. Prepare and present clinical study reports, regulatory submissions, and other relevant documentation. Ensure adherence to Good Clinical Practice (GCP) guidelines, ICH regulations, and other relevant regulatory standards. Collaborate effectively with cross-functional teams, including R&D, regulatory affairs, quality assurance, and medical affairs, to achieve project milestones. Build and maintain strong relationships with key stakeholders, including investigators, CROs, and regulatory authorities. Monitor and manage project timelines, budgets, and resources effectively. Identify and mitigate project risks proactively. Proficiency in clinical trial management software and systems. Required Qualifications: M. Pharma/Ph.D Min. 8 to 12 years of experience in clinical project management within the pharmaceutical industry. In-depth knowledge of EU regulatory requirements for drug development and clinical trials Strong understanding of clinical research methodologies and statistical principles. Proactively manage project risks, develop mitigation strategies, and communicate effectively to project teams and management. Strong leadership and interpersonal skills with the ability to build and motivate cross-functional teams. Preferred Qualifications: - Experience in OSD product development and clinical trials. Knowledge of global regulatory requirements.
Posted 1 month ago
2.0 - 7.0 years
6 - 10 Lacs
Patna
Work from Office
Responsibilities: * Lead zonal sales strategy & execution * Manage distribution network & growth * Oversee pharmaceutical product launches * Develop doctor relationships & activations * Build strong team performance Provident fund
Posted 1 month ago
2.0 - 7.0 years
6 - 10 Lacs
Lucknow
Work from Office
Responsibilities: * Manage zonal sales team for pharma products * Lead distribution development & doctor activities * Build strong customer relationships * Drive revenue growth through strategic planning & execution Provident fund
Posted 1 month ago
8.0 - 13.0 years
11 - 21 Lacs
Gurugram
Work from Office
Purpose: Primarily responsible of consolidated portfolio management of Global Projects managed within RnD, Data and repository management, analytics helping management and leadership with Key decision making which is based on data, Budget Management, Support in Defining Shared Goals Targets and tracking the same, Capacity mapping, Review Management, Analytics on activities performed within RnD based on Historical data, Tracking overall project progress and RAG Reporting, Working with Dashboards like Tableau, Critical Chain Project Reports supporting Project Management Team and RnD Functional Heads on various Data driven inputs resulting to corrective actions where ever required. Roles and Responsibilities Role requires awareness on Project management methodologies and end to end project life cycle knowledge. Risk/Issue Management, Change Management, Re-prioritization, Optimization and Automating activities will be key requirement for the role Experience with working, managing and analyzing huge data sets. RAG Reporting and escalate things on timely manner to avoid impact on deliverables. Prioritization, On Time Delivery, Excellent in Data Handling, Analyzing and Summarization of the outcome. Automations, Dashboard and CCPM Tool report management, Budget and work plan management, global portfolio and project tracking, Review management, and MIS Readiness will be some of the key activities where in a person will be supporting Meeting Management, Stake holders management and understanding requirement and delivering outcome oriented analytics, which can help in decision making which is data driven. Key Skills Role will require excellent communication skills, good in co-ordinations, team player and will be required to work with all stake holders and departments within and outside R&D. Good with analytics, logical and lateral thinking, advance excel with key formulas, MS Office, MS Projects and power point knowledge, added advantage if aware of macros, SQL Queries and Dashboards. Innovative thinker, Flexible Approach, Go-getter with leadership skills as role requires interactions and getting work done with support of Peers, juniors, seniors and Leadership team.
Posted 1 month ago
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