8 Cgmps Jobs

At Lilly, we are dedicated to uniting caring with discovery to enhance the lives of people worldwide. As a global healthcare leader based in Indianapolis, Indiana, we strive to bring life-changing medicines to those in need, advance the understanding and management of diseases, and contribute to our communities through philanthropy and volunteerism. Our priority is always people, and we are seeking individuals who are committed to improving lives across the globe. As a Shift Supervisor for Environmental Monitoring (EM) Technicians at our Indianapolis Parenteral Plant, your role involves providing supervision to ensure compliant customer service to production operations. You will oversee routine environmental monitoring in aseptic manufacturing, filling, and support areas, offering technical support to various departments within the plant. Key Objectives/Deliverables: - Enforce compliance with procedures, methods, and regulatory commitments related to EM and production operations. - Maintain adherence to cGMPs and uphold data integrity. - Ensure department compliance with EM Quality Systems, cGMPs, and Good Documentation Practices, escalating issues as needed. - Conduct routine environmental monitoring of production areas and viable monitoring of personnel where applicable. - Manage daily operations to meet customer requirements, including workload distribution and shift communication. - Develop Performance Management for employees, provide coaching and feedback, and recognize performance accomplishments and areas for improvement. - Provide shift support on issues and electronic disposition of area and equipment holds based on EM data. - Uphold a safe work environment, prioritize safety, and support HSE Corporate and Site Goals. Minimum Requirements: - Excellent interpersonal skills with demonstrated teaching and coaching abilities. - Strong understanding of environmental monitoring and supported production or lab operations. - Familiarity with related manufacturing areas and associated environmental monitoring. - High degree of cGMP understanding. Additional Preferences: - Minimum 3 years of experience in Environmental Monitoring. - Certification as a CAPA Lead Investigator with Root Cause Analysis expertise. Operations Leadership Education Requirements: - High School Diploma or equivalent. Other Information: - Gowning certification required for EM operations support. - Awareness of allergens in the work area. - Comfort working in a dynamic and fast-paced environment. - Weekend work is necessary, and shift supervisors will work the supported shift. - Post-offer testing exam may be required. At Lilly, we are committed to ensuring equal opportunities for individuals with disabilities in our workforce. Our employee resource groups offer strong support networks for all employees, including groups like African, Middle Eastern, and Central Asian Network; Black Employees at Lilly; Chinese Culture Network; and more. The anticipated wage for this position is $35.33 - $58.89, depending on candidates" education, experience, skills, and location. Full-time employees are eligible for a company bonus, comprehensive benefits program, and well-being benefits. Lilly reserves the right to adjust its compensation and benefit programs at its discretion.,

As a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd, you will be responsible for overseeing the Gamma Irradiation of Sun Pharma products at third-party gamma irradiation sterilization sites. Your primary role will involve supervising the sterilization process, monitoring the irradiation of batches, and ensuring compliance with quality assurance regulations and auditing techniques. Key responsibilities include: - Demonstrating a sound understanding of pharmaceutical manufacturing processes for both non-sterile and sterile formulations. - Supervising the Gamma sterilization site used for sterilizing drug products and components. - Monitoring the receipt and dispatch of Sun Pharma consignments at the sterilization site. - Reviewing and analyzing irradiation processes and related documentation. - Controlling and monitoring quality systems to ensure compliance with cGMPs. - Participating in investigations for deviations, OOS, and audit findings related to Sun Pharma products. - Reviewing changes in the sterilization process and promptly notifying management. - Assisting in external audit preparations and responding to audit findings. To excel in this role, you should have: - A Bachelor's degree in Pharmacy or a Master's degree in Science. - 10-15 years of industrial experience in formulation and quality systems management. - Exposure to regulatory agency audits such as USFDA, MHRA, ANVISA, TGA, WHO, and ISO. - Familiarity with Trackwise, LIMS, and SAP systems is desirable. - The ability to communicate effectively in a multicultural matrix organization. - Basic computer skills in Microsoft Word, Excel, and PowerPoint. If you are a detail-oriented professional with a passion for ensuring product quality and compliance with regulatory standards, we invite you to apply for this challenging and rewarding position as a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd.,

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talented individuals committed to enhancing patient lives through a combination of cutting-edge science and unwavering dedication to quality. The company values highly motivated individuals with integrity, dedication, and creativity to thrive within its organization. The Technical Operations department at Azurity is responsible for overseeing technical process strategy, managing contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and delivering product objectives in line with company policies and client requirements. This role involves leading teams, collaborating cross-functionally, and achieving project milestones to support process scale-ups, validation, technical transfers, post-approval changes, and investigations for commercial products. **Principal Responsibilities:** - Manage the planning and execution of manufacturing activities, including qualification and validation for both development and commercial products. - Coordinate with contract facilities to review, approve, and execute controlled documentation related to late-stage development, qualification, validation, and manufacturing activities. - Direct tasks associated with late-stage product/process development, product transfers, equipment qualifications, and validation to ensure alignment with company objectives. - Support or lead product launch and commercialization efforts. - Establish and maintain policies, SOPs, and documentation to support validation practices per regulatory requirements and industry guidance. - Assist in Management Review and Compliance activities, preparing metrics and summaries for senior management communication. - Support Due Diligence activities related to product development, technical transfer, manufacturing, and commercial launch. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. **Qualifications And Education Requirements:** - Bachelor's degree in Life Sciences (Master's degree preferred) or related field. - Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Expertise in cGMPs, ICH, and Validation related requirements. - Proficiency in technical transfer of multiple dosage forms, various validation disciplines, and regulatory agency inspections. - Ability to work strategically, tactically, and hands-on. - Proficient in Microsoft Word, Excel, and Powerpoint. By applying for this role, you confirm your capability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,

The role involves supervising the labeling and packaging of medical devices in a controlled environment. This includes overseeing the packaging of products in blister or pouches. You will be responsible for creating and modifying labeling for finished products, ensuring adherence to design and branding guidelines. Collaborating with various departments to address labeling inconsistencies and meet project objectives is an essential part of the role. Managing labeling change requests within the document management system is also a key responsibility. Ensuring that all activities comply with cGMPs and writing/updating SOPs related to department activities are crucial aspects of the position. You will be expected to recommend and implement process improvements to enhance quality, reduce costs, and improve safety measures. Identifying the developmental needs of team members and providing coaching and mentoring to support their growth is also part of the role. Additionally, suggesting solutions through designated channels is an important aspect of the job. This is a full-time, permanent position with benefits including food provision, health insurance, paid sick leave, paid time off, and a Provident Fund. The work schedule consists of day and morning shifts with a yearly bonus. The preferred education level for this role is a Bachelor's degree. Previous experience in the pharmaceutical industry is preferred, with at least 1 year of relevant experience. The work location is in person.,

The core job responsibilities for the position holder include: Responsible for operating, cleaning, and performing primary maintenance on negative isolator, Vibro sifter, Bin blenders, and all other GEA granulation line equipment. This includes recording activities in logbooks, Batch manufacturing records, and completing documentation required for product manufacturing and equipment cleaning, while following cGMPs and good documentation practices. Performing all in-process checks and monitoring of intermediate processes in granulation. Selecting recipes and setting process parameters in Blender HMI, ensuring correctness before blender operation. Issuing, utilizing, cleaning, and retrieving sieves, as well as handling machine change parts inventory appropriately. Setting up, changing over, and operating various manufacturing equipment within the granulation department. Reporting or escalating any conditions or problems that may impact product quality or integrity to the supervisor and HOD production. Maintaining a neat, clean, and safe working environment at all times, and promptly notifying the supervisor of any safety concerns, accidents, or injuries observed. Conducting in-process checks and monitoring of intermediate processes, verifying process parameters in PLC/SCADA according to BMR before machine operation in the granulation area. Ensuring compliance with current Good Manufacturing Practices in the Hormone Facility and following GDP with data-integrity compliance. Completing training and training records within the stipulated time frame. Preparing and utilizing disinfectant and cleaning agent solutions following defined procedures. Adhering to all company policies, procedures, SOPs, and safety regulations.,

As a Manufacturing Process Engineer in the Pharma Solutions sector, you will be the subject-matter-expert providing real-time process engineering support to the manufacturing process at our facility in Lexington, Kentucky. Your primary responsibilities will include designing, project managing, and implementing new and existing systems, utilities, and equipment to ensure Quality, Compliance, and improved OTIF for all products produced. You will report directly to the Engineering Manager and work on Continuous Improvement Projects, providing technical expertise in specifying, installing, troubleshooting, and maintaining systems, equipment, and processes. Additionally, you will support day-to-day production and maintenance activities, provide training support as required, and develop or modify SOPs for processes and equipment. To be successful in this role, you should hold a Bachelor's degree in Mechanical, Electrical, or Chemical Engineering with a minimum of 3-5 years of pharmaceutical manufacturing/maintenance experience. Expertise in troubleshooting production equipment/systems, flexibility to work a 24-hour operation schedule, and proficiency in PC applications such as Word, Excel, and PowerPoint are essential. Experience with maintenance and administration of computer networks, PLCs, HMI software applications, and cGMP regulations is also required. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. As part of the Piramal Group, we are committed to inclusive growth and ethical practices. We value equal employment opportunity and base our decisions on merit, ensuring all applicants and employees receive fair treatment. Join our team at Piramal Pharma Solutions and be part of a globally integrated network of facilities offering a comprehensive range of services, from drug discovery solutions to commercial supply of APIs and finished dosage forms. Your expertise in pharmaceutical manufacturing and maintenance will contribute to our mission of providing high-quality services to innovators and generic companies worldwide.,

The core job responsibilities of the position holder include: Responsible for the operation, cleaning, and primary maintenance of negative isolator, Vibro sifter, Bin blenders, and all other GEA granulation line equipment. Record activities in logbooks, Batch manufacturing record & complete documentation following cGMPs and good documentation practices. Perform all in-process checks and monitoring of intermediate processes in granulation. Select recipes, set process parameters in Blender HMI, and ensure correctness before blender revolution. Issue, utilize, clean, and retrieve sieves and handle machine change parts with inventory. Set up, changeover, and operate various manufacturing equipment in the granulation department. Report or escalate any conditions or problems affecting product quality to supervisor and HOD production. Maintain a neat, clean, and safe working environment, reporting safety concerns, accidents, or injuries to the supervisor immediately. Conduct in-process checks, monitor intermediate processes, set process parameters in PLC/SCADA per BMR before machine run in granulation area. Ensure compliance with current Good Manufacturing Practices in the Hormone Facility and follow GDP with data-integrity compliance. Complete training and training records within stipulated time. Prepare and use disinfectant and cleaning agent solutions following defined procedures. Adhere to all company policies, procedures, SOPs, and safety regulations.,

Skill required.. •Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description). Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits • Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding of domains such as Network security, Firewall audits, VA/PT, Access Management etc. Should have experience in domains such as ISAE3402 • Strong knowledge of Qualification and Validation project development/implementation processes. • Excellent FDA GxP understanding. • Knowledge of SoX, cGMPs, FDA and EMA guidelines. • Preferred Certifications: ISO 27000 LA, CISA, CISM, CISSP, ISO 9000 • Experience in planning & conducting & leading internal audits on information security, pharma quality & compliance • Experience in audits of ITSM processes (Change Mgmt, Incident/Problem Mgmt). ITIL V3 foundation must. • Good Program/Project management skills along analytics & reporting skills with strong communication & presentation. • Ability to work with all level of clients & internal resources • Knowledgeable about Business Continuity Management & Disaster Recovery. ISO 22301 experience preferred. JD • Point of contact for client stakeholders as well as HCL Operations team for guidance & support regarding compliance control requirements and implementation into service operations • Create & Document the control compliance plans for all services in scope • Lead Compliance processes for large Pharmaceutical Client for specific geography • Manages the infrastructure Qualification of hardware/Servers. • Maintains categorization of Off-the-shelf validation categories. • Ensure that the operations run-books & SOPs are inline & map with Policies, Standards, and Guidelines relating to security, privacy, and confidentiality for the Client IT Environment. Development of Security plan & ensuring adherence for all security domains relevant for in-scope services • Develop & Plan internal audit calendar aligned to clients internal as well as external audit schedule • Execute Security audits as per the agreed upon plan with client stakeholders and work with operations teams for remediation of any gaps and non-compliances • Provide agreed upon and ad-hoc reports for audits & compliance operations. • Facilitate in-time evidence provisioning to client audit, risk & compliance teams at time of external audits • Conduct process audits for ITSM as per agreed upon process controls • Participate in client meetings and committees that investigate compliance needs and develop new and modified Policies, Standards, and Guidelines We are looking for functional consultants have extensive experience in GxP related policies & process definitions and enforcements.