84 Stability Studies Jobs - Page 4

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

*Greetings*!! *We Are Hiring_Quality Control _ Chennai Location* *Education*- B.Sc / M.Sc *Experience* - 2 to 5 Years *Location* - Chennai *Preferable Candidate from only Pharmaceutical Manufacturing* Key Skills - handling HPLC , QMS , Raw materials and Wet Analysis For more details and to apply, please reach out at pna@softgelhealthcare.com or call 8608396077 References will be highly appreciated

The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. About the Role: The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. Key Responsibilities: Coordination and management of analytical method transfers and stability studies. Compilation of data reports. Compilation of Quality control monographs describing test procedure and specification setup. Scientific analytical support for quality control, production, registration, marketing. Presentation and discussion of analytical data in local and international project teams. Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as we'll as changes and complaints. Cross-functional interface with Manufacturing Science Technology team, analytical development, production and regulatory department. Management and coordination of analytical activities at external laboratories (CROs). Support for trouble shooting activities and continuous improvement initiatives. Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)). Budgeting and cost control of external analytical activities. Contribution to QC/AST network teams. Management of reference substances and control samples. Essential Requirements: Minimum 10 years in pharmaceutical industry and/or analytical laboratory in GMP environment. MS Office- and other standard IT applications. External orientation: proactive communication, collaboration and exchange with PUs and SUs within local organisation and Novartis organisation. Innovation: continuously thrives for improvements and questions processes and procedures for improvements. Reacts in a flexible and fast way on changes and challenges. Ability to analyse complex processes. Desirable Requirements: Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Language proficiency: English, German optionally. Why Novartis: you'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:

Develop and optimize formulations for new and existing products Conduct pre-formulation studies, including solubility, stability, and compatibility tests Prepare laboratory-scale and pilot batches and analyze physical and chemical properties

Roles and Responsibilities Conduct stability studies, method validation, and analysis of finished products using techniques such as GC, HPLC, UV-Vis, KF, FTIR, and dissolution testing. Ensure compliance with GLP guidelines and maintain accurate records of all experiments and results. Collaborate with cross-functional teams to resolve issues related to product quality control and manufacturing processes. Develop and implement new methods for analyzing raw materials, intermediates, and finished products. Participate in method development activities to improve existing methods or develop new ones.

Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualification Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Key Responsibilities Quality Strategy & Planning Develop and implement quality control standards, procedures, and policies. Define inspection criteria and quality benchmarks. Team Management Lead and supervise a team of quality inspectors or analysts. Provide training and guidance to QC staff. Manage and supervise QC laboratory activities Use effective negotiation skills to drive alignment and resolve conflict Inspection & Testing Oversee routine inspections and testing of raw materials, in-process, and finished products. Ensure compliance with internal and external specifications and regulations. Documentation & Reporting Maintain detailed records of quality control activities. Analyze QC data and generate reports to identify trends and areas for improvement. Compliance & Audits Ensure compliance with ISO, GMP, or other industry-specific standards. Coordinate and support internal and external audits. Problem Solving Investigate product quality issues and customer complaints. Implement corrective and preventive actions (CAPA).

Job Band: Job Band 13 (JB13) Hiring Manager: Akhil Kodiyamtharappel Sadasivan Lead Recruiter: Tino Manimuthu Country: India Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential. JOB SUMMARY: - Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines. REPORTING: - Reports to Deputy Manager QC ESSENTIAL DUTIES: - Administration/Internal Communications: Responsible for completing testing as part of Chemical, Functional and incoming inspection. Responsible for Document Review and Approval Responsible for providing support to Global Quality projects. Responsible for providing support to complete gap assessments. Other duties and responsibilities Responsible for Analysis and inspection of raw materials, accessory items and finished product. Responsible for Document and Test Report Reviews and Approval Responsible for In-process Testing and water testing. Responsible for making sure that data is accurately recorded in accordance with guidelines. Responsible for reporting, trending, and presenting results. Responsible for Calibration of Glassware and Instruments. Responsible for ensuring products are complying to the established regulatory guidelines with respect to product compliance. Responsible for ensuring GLP and cGDP requirements are in place. Responsible for supporting WCM, Lean, Six Sigma projects, root cause analysis, Productivity projects. Responsible for empowering people by giving required training Responsible for qualification of analytical instruments and QC equipement Responsible for New product evaluation and stability studies. Responsible for Monthly trending of test results. Responsible for subcontractor training and audits. MINIMUM QUALIFICATION REQUIREMENTS: - Education: Master s degree in chemistry or Bachelors Degree in Pharmacy or Master s Degree in Pharmacy (Pharmaceutical Analysis / Pharmaceutics / Pharmaceutical Chemistry) Experience: 7 to 10 years of experience in Testing laboratory of pharmaceutical industry. Technical Experience/knowledge and Skills required in below. Knowledge on instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR/ etc) Knowledge on performing test as per Pharmacopoeial requirements (USP/IP/EP) Data Integrity Knowledge on different type of chemical analysis Able to understand and identify key objectives across the business. Able to deal with multiple issues, tasks and priorities concurrently. Knowledge about Analytical/Microbiological test and Equipment Qualification Preferable to have Knowledge about USFDA/EuGMP requirements. Need to work in all 3 shifts including night shift on requirement. Additional Requirements Capable to work in all shifts including All three shifts (Night Shift on requirement). Have strong communication skills complimented with right technical skills to drive meaningful discussions.

Responsible and Accountable for the oversight of Quality operations and GMP compliance across the West and South EPD TPM s for, LL Systems & Contract Operations in India. Effectively monitoring the rating of TPM/LL sites Lead the implementation of quality strategy and plan in the above-mentioned sites including EQD policies implementation. Implement Quality Projects at identified TPM s from time to time. Ensure quality compliance to regulatory w.r.t. labelling, stability studies and documentation across the 4 business divisions to deliver acceptable quality products coming from LL and TPM sites to consumers on sustainable basis. Develop strategy on quality as per Abbott`s EPD requirements for the Supply Chain Organization in third party and LL manufacturing sites in applicable region. Promote Quality Management System as an important management tool with increased visibility across the business and guide the team for effective implementation at 3rd party contractors. Establish robust quality management systems through the supply network and ensure compliance. Create culture which imbibes quality as a way of working through identified trainings and awareness programs for critical LL and TPM sites. Establish and implement a process to ensure all consumer complaints/ queries are addressed as per Abbott policy in stipulated time at applicable TPM sites. Establish KPI s and analyse the same periodically to improve the compliance metrics through departmental reviews. Periodic quality reviews with COQA team. Monitoring of LL & TPM tech transfers, SAP related matters and KPMG audit compliance. Deputise for Director TPM QA as per needed Ensure development needs are identified for direct reports Ensure Quality budgets are maintained and managed for TPM QA organization Ensure the COMPETE project runs as expected, efficiency and cost saving ideas are identified, managed and implemented Participate in "Management Quality Reviews" and "Functional interface meetings". Ensure that the associated TPM s are maintained in a state of Quality and compliance and the CAPA;s arising out of the audits are closed on time.