15 Gmp Standards Jobs

Are you ready for a new beginning We need your talent, knowledge and dedication to better our world with biology. Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanitys biggest challenges. Since we began more than a century ago, this has been our guide. Its how we&aposve gotten so far. And its how we&aposll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless. Were here to better our world with biology. Novonesis Global Job Description Job Title Process Engineer with food Safety speciality Job Description The objective of this role is to review and support in designing the Process Quality and Food safety aspects for the new green field Finish Goods manufacturing plant. Key Responsibility Areas Include Define and review the requirements for Compliance with QMS, Food safety, GMP standards & FSSAI requirements in line with Novozymes India and global standard. Ensure high health and Safety standards in all the operations including equipmets and operations facilities. Tasks And Responsibilities Review Formulation/Standerdisation Process flow PFD against Food safety compliances and support Engineering consultant on the matter. Responsible for Co-ordination with all relevant stake holders from the project Team, Engineering/consultanting company and SCM Operation Teams for the project delivery. Support on best sutaible Plant Layout preparation support to Engineering company for Supply chain Operation Plant. Material and Man Movement plan preparation for new SCM plant in co-ordination with Project Engineering and Management Team. Review the Equipment selction based on GMP stnadards. Compliance to all Food safety/Regulatory/EHS requirements during early design phase. Review of DQ, IQ, HQ & OQ for new equipments and delivery of the same for the process. Closely work with SCM- India Operations head on complex decisions considering Plant Scalability and Flexibility in Operation of the Plant prior to Design confirmation/Approvals. Ensure the design and layout for sustainable Food excellence and GMP practices in running plant on long term basis. Coordinate and implement relevant trainings, including GMP, Quality, Food Safety and formulation and Supply Chain Operations specific Trainings for new plant operations. Support in process development and include Quality aspect while SOP preparation. Basic Qualifications B Tech Chemical / Bio Tech with 5 to 8 years of Experience in Food Industry. Additional qualification in FSMS, FSSC 22000, QMS and with Auditing experience is added advantage. Supervisor Responsibilities No Reporting lines Head of Supply Chain Operations India Physical requirements ( For North America positions ONLY) NA Candidate profile Candidate should have Experience in working with Global teams and stakeholders Knowledge FSMS, QMS and Auditing Experience is added advantage. Challenges in position You can create an impact by Ensuring the plant design for high level of Safety standards and 100% Compliance to Food Safety and Quality Unlocking your passion by implementing new Digital technologies and processes to ehnace the food excelenece. Language of job advertisement (English default) English Could our purpose be yours Then apply today! At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV. Novonesis is dedicated to fostering a unique community by embracing and respecting differences. We make all employment decisions based on business needs, ensuring that every individual can thrive, regardless of identity or background such as ethnicity, religion, gender, sexual orientation, age, disability, or veteran status. Want to learn more Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com Not the right fit for you Even if this job isn&apost the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral! Please check out our other open positions. The right fit for you could just be a few clicks away. Stay alert: Avoid recruitment scams At Novonesis, We Are Committed To Maintaining a Safe And Transparent Recruitment Process. Please Be Aware Of Potential Scams Targeting Job Seekers And Take Note Of The Following Novonesis will never ask for sensitive personal information, such as bank account details, Social Security numbers, or passwords, at any stage of the hiring process. Novonesis does not make employment offers without conducting interviews with candidates. If you receive suspicious communication claiming to be from Novonesis, please do not share any personal or financial information. We encourage you to verify the legitimacy of the message by contacting us directly through our official channels. Show more Show less

Designation: Assistant Manager - Industry: IVD Industry - Korean Based MNC - Manesar Key Responsibilities: Operation & maintenance of HVAC, RO/DM Plant, DG sets, Compressors, and Boilers Cleanroom monitoring and utility documentation Ensuring compliance with ISO 13485 and GMP standards Coordination with QA and Production teams for utility support Qualification & Experience: B.Tech in Electrical Engineering 46 years of experience in utility operations and manufacturing setups. Interested Candidates share their cv Email : kshama.k@head2hire.com M: +91 7290007914 ( Voice & Whats app )

Receipt of Material- Physical Receipt & Entries in System ( Books) Proper Handling & Storage of Raw Material (Chemicals) As per Material Data Sheet. Working Knowledge of SAP/ERP. Follow QMS/TQM as per Standards. Adherence to GMP & Safety Standards. Required Candidate profile Ensure Compliance to ISO & OHSAS Procedures for Storage & Preservation of Material. Coordination with F&A for Timely invoice submission

As the Design Head of Packaging Machinery, you will be responsible for leading mechanical design and research & development activities for high-speed packaging and bottling machinery to ensure continuous innovation, superior quality, and optimal performance. Your key role will involve overseeing the design of various components such as moulds, conveyors, filling lines, and packaging machinery. You will be tasked with managing the entire product development lifecycle from conceptualization to commissioning. It will be your responsibility to ensure compliance with CE, ISO, GMP standards, and customer specifications. Additionally, you will be expected to implement design automation, CAD best practices, and simulation tools to enhance efficiency. Collaboration with manufacturing, procurement, and projects teams to ensure Design for Manufacturability (DFM) will be a crucial aspect of your role. You will also play a key part in mentoring engineering teams, managing multiple projects within budget constraints, and driving continuous improvement initiatives. The ideal candidate for this role should possess strong leadership skills in mechanical design, particularly in the realm of large-scale and high-speed automation. Proficiency in CAD/CAE software such as SolidWorks, CATIA, NX, and AutoCAD is essential. You should have a solid foundation in structural analysis, motion studies, and tolerance stack-up. Familiarity with CE, ISO, and GMP standards is required, along with excellent problem-solving abilities, communication skills, and vendor/client management expertise. In return, you can expect a competitive salary with incentives, exposure to global projects, and opportunities for professional development. If you are passionate about driving innovation in next-generation packaging machinery and possess the necessary skills and experience, we encourage you to apply for this exciting opportunity. Job Types: Full-time, Permanent Work Location: In person,

At Cepheid, we are dedicated to enhancing healthcare by providing rapid and precise diagnostic testing solutions. Our relentless mission inspires us every day as we strive to develop innovative and scalable technologies to address the most challenging health issues worldwide. Join our team and be part of the journey to revolutionize molecular diagnostics from concept to delivery, ultimately improving patient outcomes in various healthcare settings. Working with us offers you the opportunity to make a significant global impact in an environment that nurtures professional growth and advancement. As a Process Engineer, your primary responsibility is to develop and implement strategies to enhance continuous process performance in terms of Safety, Quality, Delivery, and Cost within a manufacturing process or production line. You will drive continuous improvement initiatives, oversee equipment and process performance, conduct validations, and troubleshoot issues to optimize throughput capacity by mitigating constraints. Collaboration with global teams is essential in this role, as you will serve as the technical liaison to engineering and manufacturing teams in the US, Sweden, and India during the equipment/process lifecycle. Key Responsibilities: - Lead the planning and execution of installation and validation processes for new or existing equipment and products in compliance with company standards, IVD regulations, and GMP standards. - Prepare and maintain documentation in adherence to QMS requirements, including validation plans, SOPs, protocols, and reports. - Utilize continuous improvement tools to enhance production efficiency, reduce maintenance downtime, minimize inventory levels, and implement cost-saving initiatives. - Analyze test data to establish process or material specifications. - Conduct training sessions for Manufacturing personnel and peers on equipment processes, validations, quality requirements, and upgrades. Qualifications: - Bachelor's or Master's degree in biotechnology, electrical engineering, electronics, or related fields with a minimum of 3 years of manufacturing experience, preferably in the Medical Device/IVD sectors. - Proficiency in equipment and product validation for medical device manufacturing, including knowledge of mechanical design principles and machinery operations. - Experience working in a regulated environment (ISO, GMP, Medical Device regulations). Desired Qualifications: - Previous experience in a global work environment. - Excellent communication skills (written and oral) in English. - Strong analytical, problem-solving abilities, and technical acumen. - Familiarity with Lean manufacturing and Six Sigma methodologies. Join our dynamic team today and be part of a collective effort to accelerate the real-world impact of tomorrow's scientific and technological advancements. At Danaher, we celebrate diversity and recognize the value of unique perspectives that our associates, customers, and shareholders bring to our organization and the global markets we serve. Visit www.danaher.com for more information.,

As a Design Draftsman at Truvera, a concept to commissioning company in the Pharma and speciality chemical field, located in Vadodara, you will be responsible for creating technical, engineering, and architectural drawings. Your main tasks will include utilizing Computer-Aided Design (CAD) software to produce detailed plans and blueprints, collaborating with engineers and architects, ensuring drawings adhere to industry standards, and making revisions as needed to meet project specifications. To excel in this role, you should have proficiency in Technical Drawing and Engineering Drawings, experience with Architectural Drawings and Drawing principles, familiarity with GMP standards and regulations for Layout, and advanced skills in CAD. Strong attention to detail and accuracy in all design work is essential, along with the ability to collaborate effectively with diverse project teams. While a Bachelor's degree in Engineering, Architecture, or a related field is preferred, your practical experience and skills in design drafting will be key to your success in this full-time on-site position.,

As a Draftsman/woman in the pharmaceutical industry, you will play a crucial role in creating detailed technical drawings and documentation essential for various aspects of pharmaceutical facility design, including equipment layout, process flow, and other engineering requirements. Your responsibilities will encompass producing 2D and 3D CAD drawings for architectural, mechanical, piping, electrical, and HVAC systems. Your work will involve preparing layouts for cleanrooms, labs, production suites, and utility areas based on Good Manufacturing Practice (GMP) standards. Your role will also entail collaborating with project engineers and architects to interpret technical designs and specifications accurately. Furthermore, you will be expected to maintain drawing logs, version control, and documentation archives while ensuring documentation accuracy aligned with pharmaceutical industry codes and project specifications. To excel in this role, you must possess technical proficiency in tools like AutoCAD and Revit. Regulatory awareness, especially concerning GMP, USFDA, WHO, and other pharmaceutical regulatory norms, will be essential. Your ability to collaborate effectively with project managers, engineers, and quality assurance teams will be crucial for successful project outcomes. Attention to detail is paramount to prevent costly errors during implementation, and efficient time management will be required to handle multiple drafts within tight deadlines. Strong communication skills for clear documentation and reporting to both technical and non-technical stakeholders will also be necessary. This is a full-time position that requires in-person work at the designated location. The minimum qualification criteria for this role include an ITI in Draftsmanship (Civil), a Diploma in Civil Engineering, and a Bachelor's degree in Civil Engineering (preferred for advanced roles). If you meet these requirements and are enthusiastic about contributing to pharmaceutical facility design through precision, compliance awareness, and collaboration with multidisciplinary teams, we encourage you to apply before the application deadline on 05/08/2025. The expected start date for this position is 01/08/2025.,

You are passionate about improving health care through fast, accurate diagnostic testing. Your mission at Cepheid drives you every moment of every day as you develop scalable solutions to solve complex health challenges across the world. You are involved in every stage of molecular diagnostics, from ideation to the delivery of testing advancements that enhance patient outcomes. As a member of the team at Cepheid, you have the opportunity to make an immediate impact on a global scale in an environment that promotes career growth and development. Cepheid collaborates with six fellow Danaher Diagnostics companies to address the world's major health challenges by developing diagnostic tools that work at the pace of change, recognizing that behind every test, there is a patient waiting for results. As a Process Engineer at Cepheid located in Mahadeva Kodigehalli, Bangalore, Karnataka, you will be responsible for developing and executing a plan to improve continuous process performance related to Safety, Quality, Delivery, and Cost in a manufacturing process or line. Your role involves working on continuous improvement initiatives, ensuring overall equipment/process performance, executing equipment/process validations, tracking efficiency, and problem-solving. You will also leverage your process knowledge to identify opportunities to improve throughput capacity by reducing constraints. In this position, you will be the primary lead for defining and executing installation and validation processes for new or existing equipment and products, ensuring compliance with company standards, IVD regulations, and GMP standards. You will also plan and execute documentation as per QMS requirements, apply continuous improvement tools to increase production uptime, minimize maintenance, reduce inventories, and implement cost reduction initiatives. Additionally, you will plan, compile, and evaluate test data to determine appropriate limits and variables for process or material specifications and provide training to Manufacturing personnel and peers. To qualify for this role, you should have a Bachelor's or Master's degree in biotechnology, electrical, electronics, or related engineering fields with a minimum of 3 years of experience in manufacturing, preferably in the Medical Device/IVD sectors. You should have a strong background in equipment and product validation for medical device manufacturing, understanding of mechanical design concepts, and experience working in regulated environments such as ISO, GMP, and Medical Device regulations. Previous experience in a global environment, strong communication skills, analytical abilities, problem-solving skills, and familiarity with Lean manufacturing and Six Sigma would be advantageous. Join the winning team at Cepheid today and accelerate the real-life impact of tomorrow's science and technology. Partner with customers globally to architect solutions that bring the power of science to life. For more information, visit www.danaher.com. At Danaher, diversity is valued, and the unique perspectives contributed by associates, customers, and shareholders are recognized and embraced.,

As an experienced and proactive Environment, Health & Safety (EHS) Manager, you will lead and manage all EHS initiatives in our dairy processing facility. Your responsibilities include developing, implementing, and maintaining programs to ensure a safe and compliant work environment in alignment with regulatory standards and company policies. A deep understanding of food-grade processing, hygiene protocols, waste management, and regulatory compliance specific to the dairy industry is essential for this role. Your key responsibilities will involve EHS program development & management, overseeing health & safety initiatives, ensuring environmental compliance, managing emergency preparedness, and maintaining reporting & documentation. You will be required to develop and implement EHS policies, procedures, and training tailored to dairy operations, ensure compliance with local, state, and federal regulations, conduct safety audits and risk assessments, oversee occupational health initiatives, lead incident/accident investigations, manage effluent treatment plant operations, coordinate sustainability efforts, lead emergency response planning, and maintain accurate records of all EHS activities. To excel in this role, you should hold a Bachelor's degree in Environmental Science, Industrial Safety, Engineering, or a related field with a minimum of 3-5 years of EHS experience, preferably in the dairy or food processing industry. Strong knowledge of food safety, HACCP, and GMP standards is required, along with certifications in ISO 14001/45001, NEBOSH, or equivalent being a plus. Excellent communication and training skills, proficiency in EHS software and MS Office tools, leadership abilities, strong analytical and problem-solving skills, attention to detail, a proactive approach, and the ability to work under pressure and manage multiple priorities are key competencies for success in this role. If you are a dedicated EHS professional looking to make a significant impact in ensuring a safe work environment within a dairy processing facility, we encourage you to apply for this exciting opportunity and contribute to the success of our organization.,

As a Supervisor at Sigachi located in Dahej, you will play a crucial role in ensuring the smooth production operations in line with GMP standards. Sigachi, a renowned manufacturer of Excipients for Pharma, Nutra, and food industries, has been a key player in the market since its inception in 1989. With multiple facilities in Telangana and Gujarat, Sigachi has solidified its position as a leading producer of Microcrystalline Cellulose globally. Operating under various certifications like EXCiPACT GMP, SGMP, HACCP, EDQM CEP, and ISO 9001:2015, Sigachi has built a reputation for delivering high-quality products across continents. Your primary responsibilities will include planning and organizing production schedules to meet targets for output, quality, and yield. You will oversee all production operations to ensure compliance with SOPs and GMP standards. Collaborating closely with the Quality Control department, you will focus on continuous improvement and effective resource utilization to maintain quality parameters. Additionally, you will coordinate with cross-functional teams, particularly the Engineering Department, to ensure the production of top-notch quality products. It will be your duty to provide on-the-job training for production staff and maintain updated training records. You will be responsible for reporting deviations, conducting investigations, and implementing corrective and preventive actions as necessary. Moreover, your role will involve coordinating with QA for batch release, investigating non-conforming batches, and ensuring batch identification and traceability. Maintaining equipment/instruments calibration, practicing good housekeeping, and adhering to gowning procedures are also part of your responsibilities. In terms of qualifications, we are looking for candidates preferably with a B.Sc, M.Sc, B.Pharm, M.Pharm, or B.Tech (Chemical) degree. An experience of 8 - 10 years in the Pharma Industry or Excipient Manufacturing sector will be highly advantageous for this role. If you are a self-driven professional with a keen eye for detail and a strong background in production operations, this position at Sigachi offers a challenging yet rewarding opportunity to showcase your expertise and contribute to the company's commitment to excellence.,

You should have an ITI or Diploma in Electrical Engineering or equivalent qualification. Additionally, you should possess at least 3 years of experience working as an industrial electrician in a pharmaceutical or GMP-regulated manufacturing environment. Your role will require a strong understanding of industrial wiring, control panels, and basic PLC operations. It is essential that you can read and interpret electrical drawings and schematics proficiently. Knowledge of GMP standards is mandatory, and you should be willing to work in shifts if required. Preferred skills for this role include basic knowledge of automation systems, familiarity with cleanroom operations, and pharma-grade equipment. You should also have a quick problem-solving ability and be capable of working efficiently under pressure. As an industrial electrician, your key responsibilities will involve carrying out preventive and corrective maintenance of production machinery, electrical systems, and control panels. You will be expected to diagnose and repair electrical faults promptly, ensuring all electrical work complies with GMP and safety standards. It is crucial to maintain detailed documentation of maintenance and repair work, assist in equipment calibration and validation, and provide support during regulatory audits. Collaboration with production and QA/QC teams to minimize equipment downtime and managing inventory of electrical spare parts and tools are also part of your responsibilities. This is a full-time, permanent position with benefits including Provident Fund and a yearly bonus. The work schedule may include day shifts, rotational shifts, day shift availability, and night shift availability. The work location is in person.,

As a Production Manager at Natural Biogenex Pvt. Ltd. (NBPL), a subsidiary of Natural Capsules Limited, located in Vasanthnarasapura KIADB Industrial Area, Tumkur, Karnataka, you will play a crucial role in overseeing and managing API production operations. With 10-15 years of experience in the industry and a background in MSc.(Organic Chemistry)/ MTech Chemical (Technology)/ BSc.(Chemistry), you will ensure the highest quality standards for pharmaceutical ingredients in compliance with international regulatory bodies such as USFDA, WHO, and ICH-Q7A. Your responsibilities will include supervising day-to-day shop floor operations, workforce management, batch planning, and execution. Your expertise in utility operations, shop floor management, and troubleshooting production issues will be essential in maintaining compliance with GMP standards and regulatory guidelines. You will lead customer and regulatory audits, oversee finished goods handling, and ensure customer requirements are met. Key Responsibilities: - Supervision of day-to-day shop floor operations and workforce management. - Ensuring batch planning, timely execution, and adherence to production timelines. - Troubleshooting production and operational issues efficiently. - Ensuring compliance with quality guidelines and regulatory standards (GMP, ICH-Q7A, USFDA). - Experience in unit operations, including reactors, clean room operations, jet mills, AHU, and related utilities. - Managing documentation according to SOP and GMP guidelines. - Leading customer and regulatory audits, including USFDA, TGA, and WHO Geneva. - Training and developing team members to enhance departmental performance. - Coordinating for BOQ preparation and store management. - Overseeing finished goods handling and ensuring customer requirements are met. Qualifications: - Education: MSc.(Organic Chemistry)/ MTech Chemical (Technology)/ BSc.(Chemistry) - Experience: Minimum of 12 - 15 years of experience - Knowledge: Strong understanding of various production compliances and strategies. - Skills: Excellent communication, organizational, and project management skills. Ability to work collaboratively in a fast-paced environment. Join us at NBPL to be a part of a leading API manufacturing company with cutting-edge technology, global compliance standards, and the opportunity to contribute to regulatory audits and pharmaceutical quality excellence. Competitive salary and professional development opportunities await you in our state-of-the-art Quality Control Laboratory.,

The job involves being a team member of the Engineering Maintenance & Reliability Team within the Active Pharmaceutical Ingredient department of the Manufacturing division. Your primary responsibility is to execute maintenance activities in the plant, ensuring minimal breakdowns and maximum efficiency while adhering to safety and GMP standards. You will support the Senior Engineer in planning, scheduling, and executing maintenance activities to ensure plant and equipment availability, capacity, integrity, and reliability as per company policies and procedures. Additionally, you will be responsible for maintenance tasks in the Manufacturing, Packing, and utility areas as assigned by the Senior Engineer. In this role, you will be accountable for executing shift maintenance activities, including managing available resources to achieve maintenance targets, analyzing breakdowns, diagnosing faults, and supervising equipment repairs. You will also be involved in executing a comprehensive maintenance plan, preventive maintenance, calibration, and condition monitoring activities, ensuring adherence to standards and documenting all related activities. Handling breakdown maintenance to prevent recurrence, operating equipment efficiently as per SOP, implementing new technologies to improve machine performance, managing spares, adhering to EHS compliance, and ensuring cGMP compliance are also key aspects of the role. Moreover, you will be required to provide suggestions for process optimization, continuous improvements, and self-development in mechanical engineering and leadership aspects. Major challenges include adherence to budget constraints, cost vs. performance trade-offs, aging assets leading to escalating costs, and ensuring personnel and service providers" capability and competence. You will interact internally with Central Engineering, EHS, Site and Unit heads, and externally with OEMs, maintenance contractors, industry bodies, and statutory bodies. The role requires a BE/BTech in Mechanical Engineering with 2-5 years of experience in manufacturing, maintenance, and projects. You should have a deep understanding of manufacturing processes, organizational skills, technical knowledge of Pharma/API machinery, experience in project execution, knowledge of GMP and regulatory requirements, and leadership skills in mechanical engineering activities.,

Key Responsibilities: Create and review Process and Instrumentation Diagrams (P&IDs) following industry standards and GMP requirements. Develop 3D models for process skids and plant piping systems using industry-standard software (e.g., AutoCAD Plant 3D, REVIT). Coordinate with multi-disciplinary teams including process, mechanical, and automation engineers. Ensure compliance with ASME BPE standards. Essential Skills: Experience with modular/skid design. Knowledge of cleaning and sterilization processes. Strong analytical and problem-solving abilities. Excellent attention to detail. Good communication and documentation skills. Ability to work independently and as part of a team.

KEY RESPONSIBILITIES The incumbent will work closely with the Corporate Quality Assurance teams under the supervision of the Digital Business Partner, leading articulation of key technology and digital requirements and ensuring successful rollouts. More specifically s/he will lead the following responsibilities: Business Analysis: Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase. Collect data, analyse & define the business and user requirements. Analyse business problems and facilitate in IT solution evaluation. Work closely with managers and end users to have buy-in for the proposed solution. Creating a detailed business analysis, outlining problems, opportunities, and solutions for the business users and stakeholders. Categorize the functional and non-functional requirements of the business. Conduct post project implementation acceptance and requirements reviews. Perform additional tasks as assigned by the reporting manager, time-to-time basis in DevOps mode. Prepare validation documentation related to release of GxP system. Should have sound knowledge on preparing validation artifacts for GxP IT systems. Should have knowledge of GxP system testing and validation. Sound communication skill with good amount of convincing power (intermediate level). An ideal candidate should be well planned and structured in his/her all deliverables. Must have experience in Pharma IT with hands-on expertise for handling GxP systems. IT Support and Maintenance: Provide IT administrative support for Enterprise systems but not limited to the following. User Management (Creation, Modification, Password reset etc.). User Access Rights Management. Active user list preparation. Support to Biocon users on the enterprise application on service requests, incidents and bug fixes. Periodic review of event logs (as where applicable). Provide support to vendor for fixing IT related issues during breakdowns. Responsible for adoption, creation and Maintenance of Quality Management Procedures as per IT Operation requirements. 1st level Point of Contact for all IT related queries from Biocon users for enterprise systems Co-ordination with Enterprise functional Team for finding the RCA from IT Perspective in their Incidents and CAPAs. Responsible for implement Change controls and log Incidents and deviation related to IT Functions. Responsible for adherence of SLA's defined for various IT administrative support activities. PROFESSIONAL EXPERIENCE / QUALIFICATIONS Bachelor's in Engineering or Master's degree in a related discipline, including a minimum of 4-6 years of experience gained in technology implementation in the Pharma space Specific experience as a Business Analyst in a GxP application for a pharma company Excellent oral/ written communication skills Self-starter, with the ability to work and execute independently with minimal oversight.