3 Gmp Practices Jobs

The Assistant QA Manager should possess a minimum qualification of M.Sc, B. Pharm, M. Pharm, or B.Sc along with at least 8 years of relevant experience. Proficiency in the English language is essential, as well as a background in working with sterile products manufacturing. The ideal candidate should have comprehensive experience in equipment and area qualifications and validations related to the production of sterile products. Strong documentation skills in quality assurance are a must, along with previous shop floor experience in either the Quality Control or production department. Candidates with FDA approvals in the production or QC department will be preferred, and experience in facing international audits and inspections is highly desirable. The primary responsibilities include ensuring that all plant functions and departments adhere to Good Manufacturing Practices (GMP) on a daily basis. The Assistant QA Manager will oversee online documentation tasks in compliance with Batch Manufacturing Records (BMRs) and actively participate in validations and risk assessments. The successful candidate should excel in In-Process Quality Assurance (IPQA) activities. The company is based in Nashik and is WHO-GMP approved, specializing in the manufacturing of parenteral products such as injections (liquid and dry powder), eye/ear/nasal drops, sterile ointments, and topical creams/gels. The organization focuses on exporting to private markets and supplying tenders to Ministries of Health in various countries, with a presence in 27 countries worldwide. The company's mission is to provide high-quality essential medicines at affordable prices. The salary range for this position is between 5 to 10 lacs.,

Position: Software Engineer I Veeva Quality Location: Hyderabad, India At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology, and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary: At BMS (Bristol Myers Squibb), digital innovation and Information Technology are central to our vision of transforming patients lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care. Software Engineer I role is a member of the Veeva Drug Development & Cloud team and is accountable for Veeva Configuration and Operational activities in the various vaults of the BMS Veeva ecosystem. In this role, the individual is primarily responsible for supporting platform updates, enhancements and/or end-user support & access management activities including Architecture, design, and testing. This role does not have any supervisory responsibility, however, may act as a functional mentor to more junior team members. If you want an exciting and rewarding career that is meaningful, consider joining our diverse team! Desired Candidate Characteristics: Have a strong commitment to a career in technology with a passion for healthcare Ability to understand the needs of the business and commitment to deliver the best user experience and adoption Able to collaborate across multiple teams Excellent communication skills Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo Agility to learn new tools and processes Key Responsibilities: Supporting a wide range of projects across multiple domain areas, selected candidates responsibilities will include: Collaborate closely with the Veeva Drug Dev & Quality Cloud team to obtain high level overview knowledge of the Veeva vault platform and various vaults Assist in the deployment of the Veeva Vault Platform and general releases including documentation and testing System analysis, design, and configuration to meet business requirements Contribute to all aspects of testing activities (unit, system, and/or user acceptance testing) of the vault release including script generation, execution, review, and approval Deliver on validation documentation required on the various operational activities to ensure maintenance of the systems validated state Provide operational support activities of the Veeva vaults to our global user community, such as maintenance and break-fix releases, security assessments, regulatory risk assessments, incident response, etc. Perform periodic user access review of the applications Obtain/maintain a Veeva Associate Administrator Level certification Qualifications & Experience: Requires thorough knowledge of the principles and concepts of a discipline and developed knowledge of other related disciplines, typically gained through a university degree and 2-3 years of experience. Works within established procedures. Actively participates in troubleshooting of routine problems. Makes decisions that impact own work and other groups/teams. Works under minimal supervision. Does not have any supervisory responsibility, however, may act as a functional mentor to more junior team members. Experience in implementing/supporting SaaS (Software as a Service) solutions Experience in automated testing tools Experience in life science industry with Quality domain knowledge Experience in GMP (Good Manufacturing Practice) practices Makes decisions while understanding the team's work and how it fits into the broader enterprise. May need support from within the team or outside the team when working on broader or complex topics in understanding environment. Identifies opportunities to improve and grow, balancing performance feedback and career development Applies a continuous improvement mindset in enhancing efficiency, quality and effectiveness or their work outputs. Displays understanding of performance metrics driving the team's goals and questions the external environment and its" implication on the goals and strategies. Able to review multiple factors of data and can effectively organize information to compare and assess short and long-term implications. Can create a well-developed recommendation and sound actions. Ideal candidate will also have Veeva Associate Administrator Level (previously called Veeva White Belt) certification. #HYDIT #LI-Hybrid,

Role Summary: We are seeking a highly competent and detail-oriented Manufacturing QA Personnel with substantial experience in Sterile Injectable manufacturing , specifically focusing on Small Volume Parenterals (SVP) including Dry Powder, Liquid, and Lyophilized Injections . The selected candidate will ensure shop floor compliance and enforce GMP practices to maintain a state of readiness for inspections and regulatory compliance. Role & responsibilities : Ensure cGMP compliance on the shop floor during all stages of sterile manufacturing (formulation, filtration, filling, lyophilization, sealing, and visual inspection). Conduct and supervise line clearance, in-process checks, and aseptic practices adherence. Monitor and record activities for Dry Powder, Liquid, and Lyophilized Injectable production lines. Perform real-time batch record review and initiate necessary corrections. Ensure cleanroom behavior compliance , including gowning validation, personnel movement monitoring, and hygiene compliance. Coordinate with Production, QC, and Engineering for investigation of deviations, change controls, and CAPAs related to the manufacturing process. Participate in the qualification/validation activities including media fills, equipment qualification, and cleaning validation . Review SOPs, protocols, and BMRs for compliance with regulatory standards and internal policies. Provide training and on-floor guidance to production teams regarding QA best practices and compliance expectations. Ensure readiness for audits and inspections by maintaining appropriate documentation and control practices. Collaborate with cross-functional teams for continuous improvement and risk mitigation in manufacturing QA processes. Required Skills and Competencies: Strong understanding of sterile injectable manufacturing processes and controls, especially for SVP, Dry Powder, and Lyophilized dosage forms. Hands-on knowledge of cleanroom classifications, aseptic techniques, environmental monitoring , and equipment sterilization/cleaning . In-depth knowledge of cGMP, WHO, EU GMP, and PICS regulations . Experience handling deviations, OOS, CAPA, change controls, and batch record reviews . Ability to work in cross-functional teams and provide real-time QA support to operations. Proficiency in documentation practices and QA audits/inspections . Good communication, observation, and leadership skills.