3 Process Validations Jobs

Job Description: As a Specialist in Process Development at Dr. Reddys Laboratories Ltd., you will play a vital role in the pharmaceutical development process. Your responsibilities will include conducting strategy evaluations, designing and optimizing pharmaceutical processes, calculating batch sizes, performing scale-up calculations, handling exhibit batches, and preparing technical documentation. Your expertise will ensure the successful development and scale-up of pharmaceutical products, with a focus on oral solid formulations and process validations. Key Responsibilities: - Conduct strategy evaluations to design and optimize pharmaceutical processes for efficient and cost-effective development. - Calculate batch sizes for early development and commercial production, considering critical parameters and quality standards. - Perform scale-up calculations and execute scale-up processes to transition from lab-scale to production-scale successfully. - Handle exhibit batches, coordinating activities and documentation to meet regulatory requirements and project timelines. - Prepare and maintain technical documentation, including development reports, process validation protocols, and regulatory filings. - Collaborate with cross-functional teams to drive process improvements, troubleshoot issues, and ensure product quality and consistency. - Stay updated with industry trends and regulatory guidelines, incorporating best practices and innovative technologies into the development process. Qualifications: - Educational Qualification: Masters in Pharma/Biotechnology/Chemical Engineering - Minimum Work Experience: 4-6 years of experience in Process Development/Manufacturing Skills & Attributes: Technical Skills: - Experience in process optimization, development, and troubleshooting in relevant dosage forms or technologies. - Hands-on experience in end-to-end scale-up. - In-depth understanding of process techniques, equipment knowledge, deficiency management, and product validations. - Experience in manufacturing process improvement and oral solid formulations. Behavioral Skills: - Excellent communication and interpersonal skills. - Strong analytical and problem-solving abilities. - Performance-oriented with the ability to build and leverage relationships. - Collaborative work approach with own team and cross-functional teams. Company Culture: At Dr. Reddys, we prioritize accelerating access to affordable and innovative medicines because "Good Health Can't Wait." Our work culture is driven by a common purpose and value system that fosters individual ability, teamwork, and shared success. We believe in empowering people to lead healthier lives through empathy, dynamism, and a culture that values diversity and common goals. For more information, please visit our career website at https://careers.drreddys.com/#!/,

As a General Manager of Quality Assurance with 5-10 years of experience, your responsibilities will include validations and qualifications, preparation and implementation of the VMP & CMP, process validations, cleaning validation, and facility validation. You will also be in charge of equipment and instrument qualifications including URS, DQ, IQ, OQ, and PQ. Handling of deviations/incidences, internal quality audits, GMP audit system, annual product review, vendor audits, and qualifications are crucial aspects of this role. Your duties will also involve documentation, effective implementation of the document control system, preparation of Standard Operating Procedures (SOP), GMP & GLP records, and approval of Master Formula Records and batch manufacturing records. Quality control and stability studies will be under your supervision, and you should be fully conversant with the latest GLP requirements. Experience in handling sophisticated instruments like HPLC, GC, FTIR independently is required. Moreover, familiarity with ANDA and EU submissions, handling of regulatory deficiencies/queries work, preparation of Drug Master Files & dossiers for export markets are important responsibilities. Your expertise in ensuring compliance with quality standards and regulations will be essential in this role. If you are a detail-oriented professional with a solid background in quality assurance and a proven track record of successfully managing quality control processes and regulatory submissions, we encourage you to apply for this position.,

Urgent Required Dy Manager - Process Design & Development in MNC for Lonikand Pune location, its near to Kaharadi, Pune Required Qualification: Bachelor's Degree Required Experience: 9 Yrs. to 12 Yrs. Role & responsibilities : Lead a team of Process design & development of wire harness products. Prepare development plan, develop, track the development progress and report to management. Study drawings, specifications & identify the product requirements related to manufacturing and testing of product, customer specific requirements. Prepare & maintain documentation related to mfg processes like PFD, PFMEA, list of equipments, tooling fixtures, list of SC,CC characteristics, floor plant layout. Knowledge of IQS software is added advantage. Implement necessary poks yoke on assembly line by identifying failure modes, referring past trouble data, lessons learnt. Assembly line balancing using effective lean manufacturing concepts. Carrying out necessary Process Validations trials and finalise pocess parameters at each station on the assembly line. Extensive knowledge & experience of working on IATF 16949, VDA 6.3, ISO 14001 quality standards. Experience in facing customer, global & internal audits independently. Hand over the equipment and all design, validation records to respective departments. Should be able to study machine specs and selection of machineries required for mfg of wire harness products. Interfaces with internal departments (Manufacturing, Quality, Sales and Purchase) to ensure design objectives are met in a timely manner and assists by providing product information and engineering samples. Support department initiatives by working with other engineers to solve problems and fulfill initiative requests from Engineering Management. Supports current product with continuous improvement and supports resolution of customer issues by Quality or Engineering. To plan, execute, review and control various activities affecting quality of product, process and system in his area. knowledge in Pneumatic parts required for Automation, PLC Programming, integration of LVDT, Various Sensors, Stepper Motors, Servo Motors etc. Explore new suppliers; Technically evaluate suppliers for requirement of developing Processes, Production line fixtures, Machines, Testers, Process Automation Should be skilled at written & verbal communication with overseas colleagues. Must possess ability to build peer relationships as well as work independently. Must be action oriented, ethical in value, and have a strong customer focus Preferred candidate profile Mechanical Engineering with WH product and its processes. Experience in design development of wire harness assembly equipments, Automation. -Mechanical Engineering with WH product and its processes. Team leader,Assembly line development, Prepare Process documentation, Facing customer audits- IATF16949, VDA 6.3, Process validations, continuous improvement, Automation Required Experience in pneumatic parts required for automation, PLC programming, and integration of LVDT, various sensors, stepper motors, and servo motors