3 Gmp Regulations Jobs

You will be responsible for designing, planning, performing, interpreting, and reporting the results of scientific experiments to prepare and deliver drug substances, drug products, and processes within a multifunctional project team led by a Project Leader. You will manage technical laboratory and plant activities. As a part of the Management Track, you will lead a team in developing pharmaceutical, biological, or cell-gene therapies in a small manufacturing plant environment. You will execute the functional strategy, drive operational excellence in line with TRD vision and strategy, and ensure full portfolio support in alignment with GDD, Sandoz, NTO, and NIBR plans. In the role of an Associate Scientist, you will design, plan, perform, interpret, and report scientific experiments for the development and timely delivery of drug products within a project team. Additionally, you will manage technical lab and plant activities. As a Scientist, you will be responsible for designing, planning, performing, and interpreting scientific experiments for the development and timely delivery of drug products. You will lead and manage project activities, support team members, contribute to overall strategies and goals. In the position of a Senior Scientist, you will design, plan, perform, document, and interpret scientific experiments and GMP testing or pilot plant processes for generic products. You will maintain equipment, manage operational aspects in the lab or plant, and ensure timely delivery. Key Responsibilities: - Meet quality, quantity, and timeline goals in all projects while aligning with the overall drug development process. - Plan, organize, perform, and document scientific experiments in collaboration with project teams under minimal guidance. - Provide efficient processes for specialized facilities and manufacturing operations. - Document raw data, evaluate results, propose next experiments, and optimize methods and workflows. - Generate lab procedures, reports, instructions, and SOPs, and transfer procedures to production. - Communicate problems, conduct safety searches, manage chemicals, and collaborate with team members. - Evaluate new equipment, contribute to maintenance, and ensure adherence to quality and compliance standards. - Support resource planning, quality mindset, and training compliance. - Adhere to HSE rules and guidelines, contribute to increasing efficiency, and provide measurable contributions to projects. Minimum Requirements: - B. Pharm /M. Pharm with 3-8 years of relevant experience. - Experience in safe handling of chemicals and equipment, working in interdisciplinary teams, and knowledge of SOPs and GMP regulations. - Proficiency in scientific/technical areas, laboratory tools, software, and communication skills. Join Novartis to be part of a community dedicated to helping people with diseases and their families. Collaborate, support, and inspire breakthroughs that change patients" lives. Ready to create a brighter future together ,

As a Quality Assurance Inspector in Southeastern Massachusetts, you will play a vital role in ensuring the quality and compliance of pharmaceutical manufacturing operations. With a minimum of 3 years of hands-on QA experience in a regulated cGMP pharmaceutical production setting, your primary responsibility will be to conduct on-the-floor quality inspections and monitor manufacturing processes. Your keen attention to detail and understanding of cGMP standards will be instrumental in maintaining regulatory and internal quality standards. Your day-to-day tasks will include conducting routine in-process checks, performing line clearance and area readiness checks, executing visual inspections, and submitting product samples for laboratory analysis. You will also be responsible for maintaining and calibrating standard weights, tracking facility conditions, reviewing support documentation, and confirming equipment functionality during manufacturing runs. Additionally, you will assist in investigations of quality-related complaints, document any non-conformities, and participate in cross-functional improvement projects. To qualify for this role, you must have a high school diploma or equivalent, with additional training or coursework in pharmaceutical manufacturing or life sciences preferred. Direct experience with MDI manufacturing is advantageous but not mandatory. A solid understanding of GMP regulations, proficiency in using tools like Microsoft Word and Excel, excellent communication skills, and the ability to work both independently and collaboratively in a fast-paced production setting are essential for success in this position. If you have a minimum of 10 years of experience as a Quality Assurance Inspector in the pharmaceutical industry, with expertise in GMP, CGMP, manufacturing, MDI, solid dosage forms, liquids, tablets, and capsules, and you are looking for a full-time role where you can contribute to maintaining high-quality standards in pharmaceutical production, we encourage you to apply for this opportunity. This position requires in-person work and an expected commitment of 40 hours per week.,

We are seeking a seasoned Associate General Manager Human Resources to lead HR functions at Evertogen Life Sciences, our OSD formulation manufacturing facility. In this pivotal role, you will design and execute HR strategies that support business objectives, drive employee engagement, and ensure compliance with statutory norms. You will oversee talent acquisition, performance management, and learning & development, while also handling employee relations, grievance resolution, and disciplinary actions. You will collaborate with department heads to align manpower planning with succession strategies and lead initiatives to support internal and regulatory audits. Your role will also involve budgeting for HR activities and managing leave and overtime processes. If you are passionate about building a high-performing and compliant workforce, we invite you to apply. Job Details: Industry: OSD Formulation (Pharmaceuticals) Department: Human Resources Role: Associate General Manager Human Resources Location: Jadcherla Compensation: Up to 18 LPA Experience: 13-18 Years Employment Type: Full-time Qualifications: Bachelor's degree in Human Resources or related field; MBA in HR preferred. Responsibilities: Strategic HR Leadership & Talent Acquisition Develop and execute HR strategies aligned with organizational goals. Guide department heads on workforce planning and talent management. Lead change management initiatives for continuous improvement. Create and implement HR policies aligned with laws and best practices. Analyze HR data to recommend improvements. Develop succession plans for critical roles. Talent Acquisition & Employer Branding Oversee end-to-end recruitment lifecycle. Build strategies to attract top industry talent. Manage external hiring partners. Monitor hiring metrics for process optimization. Ensure recruitment compliance with labor laws. Strengthen employer branding initiatives. Employee Development & Performance Management Implement and manage the performance appraisal process. Identify training needs and create development programs. Coach and mentor employees. Ensure effective onboarding for new hires. Evaluate training outcomes and adjust as necessary. Manage the learning & development budget. Employee Relations & Engagement Address employee concerns and grievances. Ensure fair handling of disciplinary issues and terminations. Develop initiatives to enhance employee morale. Conduct exit interviews to gain retention insights. Promote a culture of recognition and appreciation. Compliance & Regulatory Affairs Maintain up-to-date employee records. Ensure compliance with labor laws including the Factories Act, ESI, and PF. Support and participate in internal and external audits. Stay current on labor regulations and ensure adherence. Budgeting, Leave & Overtime Management Plan and manage the HR departmental budget. Monitor and manage employee leave records. Oversee overtime approvals and records in coordination with payroll. General Expectations and Past Experiences: Experience in HR strategy within the pharmaceutical industry. Sound understanding of Indian labor laws and GMP-related compliance. Proven team leadership capabilities. Proficiency in handling talent acquisition, performance management, and employee relations. Strong analytical, communication, and problem-solving skills. Ability to collaborate with cross-functional teams at all levels.