4 Qbd Principles Jobs

You should have a comprehensive understanding of product development activities for all injectable dosage forms meant for the regulated market. This includes working with complex injectable products like suspension-based formulations, liposomal formulations, and Polymer based products. Your responsibilities will also involve preparing and reviewing product development reports, MFR, stability protocols, study protocols, and SOPs. Additionally, you should have a basic grasp of implementing QbD principles for formulation and development, including QTPP, CQA, CPP, CMA, risk assessment, and control strategy. Effective coordination with various departments such as regulatory affairs, manufacturing warehouse, quality assurance, quality control, and engineering is essential for the successful execution of scale-up and exhibit batches. Qualifications - M.Pharm (Pharmaceutics) Amneal is committed to being an equal opportunity employer that values diversity and inclusion. Discrimination based on caste, religion, gender, disability, or any other legally protected status is not tolerated in our workplace. The Human Resources team at Amneal plays a crucial role in partnering with all aspects of the organization to drive success through effective and innovative people management to meet both current and future business needs. Key roles that the Human Resources team performs include: - Executive Role: Specializing in all aspects of people management and providing high-level strategic input into key business decisions. - Audit Role: Ensuring compliance with legal requirements and best practice employment policies and procedures across the organization. - Facilitator Role: Collaborating closely with different departments to support, advise, and enhance their ability to achieve objectives through the implementation of effective employment practices in areas like Talent Acquisition, Learning and Development, Reward systems, Performance Management, and Health and Wellbeing. - Consultancy Role: Offering expert advice to the organization and managers on various aspects of workforce management, employee relations, and performance. - Service Role: Keeping the organization informed and equipped to handle developments affecting employment matters such as changes in legislation and characteristics of the labor market.,

We are seeking a dynamic and experienced person in Process Development Plan and execute process optimization trials & to execute scale up/ confirmatory batch and to support pilot batch, exhibit batches by applying various engineering concepts during optimization and scale up. Roles & Responsibilities You will be responsible for providing critical inputs in process design, executing experiments, and collecting and interpreting data to facilitate smooth process scale-up and ensure effective process control. This role involves collaborating with cross-functional teams, utilizing Quality by Design (QbD) principles, and finalizing batch sizes and equipment trains for successful scale-up and technology transfer. You will be responsible to demonstrate successful process scale up to ensure smooth execution of confirmatory & exhibit Batches on time. You will be responsible to prepare documents required for confirmatory/ scale up batch at plant. Perform Scale Up correlations for all unit operations from lab scale to plant scale. And provide control strategy for Exhibit Batches based on Confirmation Batch (CB) results. You will be responsible to prepare Process optimization report & filing documents. You will be responsible to analyse data and provide support in answering process related deficiencies ensuring on time response to regulatory agencies. You will be responsible to develop process capabilities within team, train new joinee /freshers. Willingness to imbibe young talent and support in the initial stages. Qualifications Educational qualification: Masters/Bachelors/Ph.D in pharma Minimum work experience: 3-5 years of experience in Process development Skills & attributes: Technical Skills Experience in the development/ scale up/ technology transfer of products in relevant dosage forms or technologies. Understanding of pharmaceutical process selection Ability to prepare technical protocols and reports. Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches. Knowledge of International Council for Harmonisation (ICH) guidelines related to Product development or Process Development. Experience in Formulation Development understanding of execution methodology (based on Critical Material Attributes, Critical Quality Attributes of products. Experience in Analytical Research and knowledge on interpretation of the data. BehavioralSkills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Performance oriented and good at building, leveraging relationship. Ability to work collaboratively with own team and cross-functional teams. Committed to Learning & Coaching the team.

You will be responsible for contributing to the reliability, scientific quality, and optimization of project support throughout the entire process from target identification to process development. This will involve performing statistical analyses of data generated in the laboratories using R and potentially other programming languages to generate statistical reports. Additionally, you will play a key role in the development and maintenance of statistical end-user tools. Your expertise will be utilized in representing statistics within various scientific or technology working groups and cross-functional initiatives. To excel in this role, you should possess a strong background in non-clinical statistics as applied to biopharmaceutical development. Your proven experience in industrial statistics, including descriptive and inferential statistics, statistical process control, design of experiments, multivariate data analysis (such as PCA, PLS, and related methods), and statistical modeling and simulation will be crucial. A sound understanding of statistical concepts and techniques, such as predictive modeling and repeated measure ANOVA, is essential. Additionally, familiarity with pharmaceutical research and development, particularly in in-vitro testing, is desirable. Knowledge of CMC regulatory guidelines from organizations such as EMA, FDA, and ICH Quality, as well as QbD principles, will be valuable in this role. Your ability to prepare statistical analyses for regulatory dossiers and ensure compliance with relevant guidelines will be pivotal to the success of the projects you are involved in.,

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals