5 Cgmp Regulations Jobs

You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OOS, and stability failures, ensuring timely closure and contamination controls as per the contamination controls strategy. You will collaborate with various departments like planning, QC, Regulatory Affairs, Manufacturing, and Engineering to ensure batches are released on time. Your role will involve participating in self-audits, aseptic simulations, and identifying opportunities for continuous improvement in compliance, process clarity, and operational efficiency. Reviewing and approving various documents such as master batch production records, protocols, reports, and stability sample management will also be part of your responsibilities. Additionally, you will manage activities related to IPQA, line clearance, in-process checks, calibration records, artwork approval, and provide training to support staff. Your focus will be on enhancing knowledge of cGMPs, improving practices, complying with the Quality Policy, and enhancing systems and procedures to ensure the quality of products manufactured and delivered meets the required standards.,

As the QC Systems Templating Senior Manager at Amgen, you will play a crucial role in leading the team responsible for creating and managing master data templates for Quality Control systems, such as ELN and the consumable inventory system, utilized globally across the Amgen QC network. Your strategic planning and prioritization skills will be essential in supporting the collective requirements of the QC organization while considering the individual needs and timelines of various sites. In this position, you will primarily work during regular hours to facilitate Amgen's mission of serving patients, and you will lead a shift-based team that provides coverage across multiple time zones. Flexibility may be required to support business needs outside of standard working hours. The role is based in Hyderabad, India, at the Amgen India-AIN office, with responsibilities extending to providing remote support to Amgen sites globally. As a Senior Manager in the Quality Control organization, your leadership responsibilities will include supervising and mentoring staff. Your focus will be on overseeing the AIN-based QC Systems team, collaborating with business process owners, managing request prioritization, ensuring compliance with regulatory requirements, driving process improvements, and more. Your tasks will involve evaluating master data requests, assigning priorities based on complexity and timelines, tracking progress, resolving roadblocks, and providing updates to the global QC network. You will also be responsible for staff training, career development, and performance management, along with ensuring alignment between sites in the use of QC systems. To qualify for this role, you should hold a Master's degree with 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience. Additionally, you must have at least 5-7 years of experience in managing people or leading teams, projects, or programs. Strong project management skills, knowledge of cGMP regulations, and experience working with cross-functional stakeholders are necessary for success in this position. Soft skills such as excellent communication, team collaboration, building high-performing teams, leadership, negotiation, and problem-solving abilities are essential. You should have a track record of innovation, staff motivation, coaching, and mentoring to excel as the QC Systems Templating Senior Manager at Amgen. Amgen is committed to providing equal opportunities and reasonable accommodations for individuals with disabilities to participate in the job application process and fulfill essential job functions. Please reach out to us for accommodation requests.,

Key Responsibilities Strategic Operational Excellence: Develop and implement a comprehensive operational excellence strategy for the API manufacturing division, aligning with overall company goals and market demands. Process Optimization & Improvement: Lead initiatives to identify and eliminate bottlenecks, reduce cycle times, and optimize production processes across R&D, manufacturing, and quality control, with a focus on cost improvement. Cost Management & Profitability: Drive cost reduction programs and initiatives to improve absorption rates and maintain profitability in a competitive pricing environment. Quality Assurance & Enhancement: Collaborate closely with Quality and R&D teams to ensure the highest quality standards are met throughout the API lifecycle, from development to final product. R&D Collaboration: Partner with R&D to ensure seamless transfer of processes to manufacturing, focusing on manufacturability and cost-effectiveness from the outset. Supply Chain Optimization: Analyze and optimize aspects of the API supply chain to improve efficiency and reduce costs, particularly at the last end of the value chain. Performance Management: Establish key performance indicators (KPIs) and metrics to track operational performance, identify areas for improvement, and report progress to senior leadership. Team Leadership & Development: Lead, mentor, and develop a high-performing team, fostering a culture of continuous improvement, accountability, and operational excellence. Customer Focus: Work closely with sales and customer-facing teams to understand customer expectations and ensure operational processes are aligned to meet those needs, maintaining a neck-to-neck relationship. Risk Management: Identify and mitigate operational risks, ensuring compliance with all relevant regulations and industry standards. Technology & Innovation: Evaluate and implement new technologies and best practices to enhance operational efficiency and effectiveness. Optimizing processes and costs at the final stages of the API value chain where inefficiencies can significantly impact profitability. Competitive Pricing Pressure: Operating in a market where competitors may offer lower prices, requiring constant focus on cost improvement and efficiency to maintain profitability. Maintaining Profitability: Balancing the need for cost reduction with the requirement to invest in quality, R&D, and process improvements to stay competitive Neck-to-Neck with Customer: Meeting demanding customer expectations regarding quality, lead times, and cost in a highly competitive landscape. Qualifications: Bachelors degree in Chemical Engineering, Pharmacy, Chemistry, or a related field. A Masters degree is preferred. Minimum of 18 years of total professional experience, with at least 10-15 years specifically in API manufacturing operations. Proven experience in implementing operational excellence methodologies such as Lean, Six Sigma, or other continuous improvement frameworks. Strong understanding of API manufacturing processes, cGMP regulations, and quality systems. Demonstrated ability to drive significant cost reductions and efficiency improvements. Experience in collaborating with R&D and Quality teams to optimize processes. Excellent leadership, communication, and interpersonal skills. Ability to work effectively in a fast-paced and challenging environment. Strong analytical and problem-solving skills.

As a Director Quality Assurance, Product Complaint and Surveillance you will report to the Executive Director, Quality Head and: Drive execution of the global complaints business process and continuous improvement Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root causes for the complaints Provide accurate and robust surveillance information that meets global health authorities and Amgen requirements Manage the Business Performance team for Combination Product Quality at AIN to ensure timely completion of goals and objectives. Leverage expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings Manage data sources used for trending, provide necessary data to technical teams for advanced analysis Ensure alignment between linked product complaint and adverse events investigations with Safety data and support for requests from global health authorities regarding the complaints process. Communicate potential product quality or business risks to leadership Escalate critical issues and findings to ensure incorporation into Management Review Contribute to inspection readiness activities Lead cross-functional initiatives to improve and strengthen complaint management system and processes at Amgen Interpret SOPs and regulatory requirements Own Process Standards, Process Overview and SOPs and ensures alignment with document hierarchy and templates Set project timelines and priorities for key initiatives and/or team activities Provide guidance and technical advice to key stakeholders involved in managing complaints Lead and develops a team, providing staff member supervision and on-going coaching Drive Operational Excellence as it pertains to complaint management processes and system Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc. Act upon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed Basic Qualifications: Doctorate degree and 8 years of Quality experience OR Masters degree and 15 years of Quality experience OR Bachelors degree and 20 years of Quality experienceAND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Combination products (medicinal product and device) expertise Strong problem solving and data driven analytics Strong leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to meet timelines Able to respond and provide astute advice quickly in difficult scenarios or in response to tough questions Strong change management skills Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results Strong aptitude for coaching and providing on-going mentoring and guidance to team Ability to operate in a matrix or team environment with site, functional, and executive leadership Experience driving decision making by using DAI principles Relevant experience having led a complaints organization Experience leading and coaching a diverse, globally dispersed team Knowledge of cGMP regulations (FDA, EMEA, TUV, Health Canada) and industry standards (ISO, ICH, PICs) Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership Highly skilled at interacting effectively with inspectors and agency regulators Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Practical knowledge of human factors principles and best practices Practical knowledge of risk assessments and their application to complaints investigation Ability to travel +/- 20% of time to domestic and international Amgen sites; ability to flex working hours to maximize interactions with global teams.

As a Director Quality Assurance, Product Complaint and Surveillance you will report to the Executive Director, Quality Head and: Drive execution of the global complaints business process and continuous improvement Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root causes for the complaints Provide accurate and robust surveillance information that meets global health authorities and Amgen requirements Manage the Business Performance team for Combination Product Quality at AIN to ensure timely completion of goals and objectives. Leverage expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings Manage data sources used for trending, provide necessary data to technical teams for advanced analysis Ensure alignment between linked product complaint and adverse events investigations with Safety data and support for requests from global health authorities regarding the complaints process. Communicate potential product quality or business risks to leadership Escalate critical issues and findings to ensure incorporation into Management Review Contribute to inspection readiness activities Lead cross-functional initiatives to improve and strengthen complaint management system and processes at Amgen Interpret SOPs and regulatory requirements Own Process Standards, Process Overview and SOPs and ensures alignment with document hierarchy and templates Set project timelines and priorities for key initiatives and/or team activities Provide guidance and technical advice to key stakeholders involved in managing complaints Lead and develops a team, providing staff member supervision and on-going coaching Drive Operational Excellence as it pertains to complaint management processes and system Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc. Act upon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 8 years of Quality experienceOR Masters degree and 15 years of Quality experience OR Bachelors degree and 20 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Combination products (medicinal product and device) expertise Strong problem solving and data driven analytics Strong leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to meet timelines Able to respond and provide astute advice quickly in difficult scenarios or in response to tough questions Strong change management skills Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results Strong aptitude for coaching and providing on-going mentoring and guidance to team Ability to operate in a matrix or team environment with site, functional, and executive leadership Experience driving decision making by using DAI principles Relevant experience having led a complaints organization Experience leading and coaching a diverse, globally dispersed team Knowledge of cGMP regulations (FDA, EMEA, TUV, Health Canada) and industry standards (ISO, ICH, PICs) Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership Highly skilled at interacting effectively with inspectors and agency regulators Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Practical knowledge of human factors principles and best practices Practical knowledge of risk assessments and their application to complaints investigation Ability to travel +/- 20% of time to domestic and international Amgen sites; ability to flex working hours to maximize interactions with global teams.