7 Stability Study Jobs

This position is responsible for managing all Quality Control Operations of a WHO-GMP & ISO approved Tablets and Capsule manufacturing facility. Specific Responsibilities: To perform HPLC and Dissolution analysis. To review and check all Raw material, packing material, bulk and finish product specification, method of analysis and all worksheet. To review and check Different validation protocol like process, cleaning, analytical method. To review and check Stability study and hold time study protocol. To ensure for timely sampling and analysis of incoming materials, like raw materials, packing materials. To ensure for timely analysis of bulk, finish product, stability sample and validation sample. Qualifications / Requirements: Experience of performing HPLC analysis. Bachelors degree in a scientific discipline (Masters Preferred). 3-7+ years of hands-on experience in the pharmaceutical industry, with specific experience in Quality Control. Job Types: Full-time, Permanent Schedule: Day shift Yearly bonus License/Certification: FDA certification Chemical and Physio Chemical Testing. (Required) Work Location: In person,

As an R&D Executive at PTC - SIGMA, you will be responsible for a wide range of activities related to documentation, product development, collaboration & coordination, and team training. Your primary responsibilities will include preparing various Technology Transfer documents such as LIF, PIF, PBOM, BOM for VAQ review, FBOM, and MFC. You will also be initiating AIF and Change control in the portal and handling SAP related activities including BOM loading, New SAP code generation, and Code extension. Additionally, you will be involved in LnB Issuance, PDR review, LnB and Project Files Archival, SOP preparation, review, and training, as well as Form 29, Form-11 application activities. In terms of product development, you will be conducting literature searches, monitoring raw material availability, aligning formulation development activities, preparing project presentations, loading products in stability studies, and analyzing stability data. You will also be responsible for preparing regulatory submission documents and ensuring compliance with SOPs during practical work. Collaboration and coordination with other departments such as ADL, PKG, RA, GDSO, and CQA will be crucial for the successful execution of day-to-day activities. Additionally, you will be expected to deliver presentations on assigned topics and share execution learnings within the team. Overall, as an R&D Executive at PTC - SIGMA, you will play a key role in driving the successful development and documentation of products, ensuring regulatory compliance, and fostering effective collaboration within the organization.,

YASH Technologies is seeking SAP PP/QM Professionals with around 10+ years of experience in PP and QM, including work on Discrete, process industries & Repetitive Manufacturing scenarios. The ideal candidate should have Certification in SAP, experience in Presales/Rollout/Upgrades/Implementation projects, and at least 4-5 End to end implementation experience in S/4HANA and ECC. Knowledge of S/4HANA and FIORI is a must, along with experience in Production planning and Quality management modules. The candidate should have worked on Sales and Operational planning, Long term planning, Material Requirement Planning, Demand Management, capacity evaluation, and production execution processes. Strong knowledge of Planning strategies such as Make to Order/Make to stock/Engineer to Order is required. Experience in Quality Planning, Quality Inspection, and Quality Improvement processes is necessary, including knowledge of Sample management, Stability Study, Inspection Scope modification, and Statistical Process Control. Strong client-facing experience, excellent communication skills, and the ability to communicate complex technical topics to both technical and non-technical audiences are essential. The candidate should be capable of design and build SAP PP/QM solutions, perform maintenance and support, and conduct Client demos as needed. Integration knowledge in Production Planning, Materials Management, Sales & Distribution, Finance, and Costing/controlling is required, with additional knowledge of APO and IBP being advantageous. Other responsibilities include integration with third-party applications, RICEFW's, master data management in both PP and QM, and creating effective reusable components. As a Business Process Consultant, the candidate must have deep product expertise/business experience and be able to independently handle implementation projects with a focus on Production Planning & Quality Management processes. Leading the project team, participating in project planning, estimation, and realization, as well as providing creative solutions to address problems are key aspects of the role. YASH Technologies offers an inclusive team environment where employees are empowered to create a career path that aligns with their goals. The company emphasizes career-oriented skilling models, continuous learning, and an ethical corporate culture. With a focus on flexible work arrangements, emotional positivity, trust, transparency, and collaboration, YASH provides a stable employment environment that supports the realization of business goals.,

As an experienced professional in SAP, you will be responsible for independently handling large implementation projects with a focus on Production Planning & Quality Management processes. Leading a team assigned to you in a functional capacity, you will add value to the project and ensure the final deliverables meet the client's expectations. Your role will involve active participation in the preparation, conception, realization, and Go Live phases of customer implementation projects. You should demonstrate proficiency in planning, running, and managing blueprint workshops and meetings with both internal and external clients. Additionally, you will be accountable for defining project scopes, estimating efforts, and managing project timelines. Participating in RFP discussions and providing estimates under the guidance of a Bid Manager will be part of your responsibilities. You will also be expected to offer creative solutions to address project challenges and deliver billable components that align with the customer's requirements. To qualify for this role, you should hold a Bachelor's degree in a related field with at least 7 years of experience in SAP. Possessing SAP Certification in Production Planning & Quality Management (PP/QM) is preferred. You should have a minimum of 2 to 3 full life cycle SAP implementations under your belt and strong knowledge of SAP Production Planning & Quality Management Modules. Your expertise should extend to good integration knowledge with other components within SAP S/4HANA, including experience in Discrete, Process Industries, and Repetitive Manufacturing scenarios. Understanding Sales and Operational planning, Long-term planning, Material Requirement Planning, Demand Management, capacity evaluation, and production execution processes is crucial. A strong grasp of all Planning strategies (Make to Order/Make to Stock/Engineer to Order), Quality Planning, Quality Inspection, and Quality Improvement processes is essential. You should also be familiar with Sample management, Stability Study, Dynamic Modification of the Inspection Scope, and Statistical Process Control (SPC). Your role will involve significant client interaction, requiring a well-developed customer focus and excellent oral and written communication skills. Mobility is a requirement, as you must be willing to travel to project locations for both short-term and long-term assignments. Your performance will be measured based on customer feedback and satisfaction scores, as well as productive days/utilization as defined by the organization. Knowledge management and the creation of effective reusable components will be key aspects of your role. Providing support for SAP PP/QM module to business users, designing and building SAP PP/QM solutions, performing maintenance and support are also part of your responsibilities. In addition, having strong ERP implementation experience, technical knowledge in PP/QM, familiarity with SAP S/4HANA Public Cloud solution, and knowledge of SAP ACTIVATE implementation methodology will be advantageous. Good communication skills are necessary to effectively communicate complex technical topics to various audiences.,

As an Analytical Technical Writer, your main responsibility will be to prepare and review analytical technical documents based on laboratory data. This includes but is not limited to product specifications, analytical test methods, validation protocols, reports, stability study protocols, and reports. You will also be required to collaborate with client stakeholders and external laboratories to gather necessary documentation. Additionally, you will be responsible for managing change control processes in coordination with cross-functional teams and ensuring timely implementation of changes. Your role will involve reading analytical laboratory data and transforming it into a report format. It is essential to have experience in verifying the completeness and accuracy of technical reports, as well as managing the lifecycle of technical documents. You will support cross-functional teams by providing technical documents for submission requirements and adhere to client documentation standards and best practices. To be successful in this role, you should hold a minimum of M. Sc. in Chemistry, M. Pharmacy, or a related scientific field. A minimum of 2-4 years of experience in Quality Control, QA documentation, R&D, or Analytical Quality Assurance is required, along with strong analytical thinking skills. If you are passionate about analytical writing and possess the necessary qualifications and skills, we invite you to join our team as an Analytical Technical Writer in Mumbai on a full-time basis.,

Job Description: As an Assistant R&D in our organization, you will play a crucial role in supporting the Research & Development team. Your primary responsibility will be to assist the R&D head in various activities related to new product development. This includes performing sampling under the guidance of the R&D head and conducting stability studies on cosmetic and perfume products as directed by the R&D and QC head. Additionally, you will be responsible for procuring raw materials for the R&D department and identifying new suppliers. You will also be in charge of preparing and maintaining documentation related to product development and stability studies. It will be essential for you to keep the R&D lab organized and maintain records of new samples in an orderly manner. This is a full-time position based in Dombivli East, with a possibility of the location shifting to Ambernath in the future. We are looking for candidates who hold a B.Tech in Cosmetic and are fresher with no prior work experience. Please note that this position is open only to female candidates. In return for your contributions, we offer health insurance and Provident Fund benefits. The work schedule is during day shifts. If you are passionate about the cosmetic industry and eager to kickstart your career in Research & Development, we encourage you to apply for this role.,

As a Formulation and Development Officer for our client based in Vatva, Gujarat, you will be responsible for various key tasks. Your primary duty will involve the development of formulations for all dosage forms such as tablets, capsules, ointments, creams, gels, oral liquids, injectables, and novel drug delivery systems for different markets including regulated, domestic, and ROW markets. This includes activities like document review, planning, and conducting stability studies of R&D batches. Additionally, you will be required to provide technical support for the scale-up and technology transfer to manufacturing processes. You will play a crucial role in troubleshooting formulation-related issues that may arise during production, ensuring a smooth manufacturing process. To qualify for this position, you should hold a Bachelors or Masters degree in Pharmacy. If you believe you possess the necessary qualifications and skills for this role, we encourage you to share your updated CV with us. We look forward to reviewing your application and will reach out to you promptly.,