72 Regulatory Inspections Jobs - Page 2

As a Quality Assurance Inspector, your primary responsibility will be to perform various inspections based on studies, facilities, and processes. You will also be required to participate in regulatory inspections conducted by organizations such as NGCMA, CDSCO, NABL, and USFDA. Your role will involve reviewing Standard Operating Procedures (SOP) and quality tools such as deviation, Corrective and Preventive Actions (CAPA), incidents, and change control. Additionally, you will be responsible for reviewing documents related to computerized system validation and instrument qualification.,

Role Overview: As a Senior Manager / DGM - Sterility Assurance at our Halol - Vadodara location, you will be responsible for overseeing the Sterility Assurance and QMS elements for Sterile manufacturing Units. Your role will involve handling Regulatory Audit Queries and ensuring the implementation of contamination control strategies in compliance with regulatory standards. Key Responsibilities: - Own the Aseptic process simulation program of the site, including protocol development, operators training, intervention qualification program, and Trending analysis. - Develop and enhance the Sites Contamination Control Strategy to ensure robustness and continuous improvement. - Lead the Sterility ...

As the Head of Quality Assurance and Compliance at our Biopharmaceutical company, your role will be crucial in maintaining the highest standards of quality, compliance, and regulatory adherence. Reporting directly to the executive leadership team, you will play a critical role in upholding and enhancing our reputation for excellence in the industry. **Role Overview:** You will be responsible for establishing and maintaining robust Quality Systems to support cGMP activities, ensuring compliance with regulatory requirements and industry standards. Your role will involve managing the Quality Control and Quality Assurance departments, overseeing document control and training systems, and leading...

You will lead and oversee AML, Surveillance, and ensure adherence to regulatory frameworks. Your responsibilities will include: - Managing regulatory inspections related to AML and Surveillance, serving as the primary liaison with SEBI, exchanges, and depositories. - Ensuring timely and accurate reporting to SEBI, Exchanges, Depositories, and FIU on AML and Surveillance matters. - Providing regular updates and risk assessments related to AML and Surveillance to the Board and senior management. - Supervising surveillance activities to detect money laundering, market abuse, and other financial misconduct. - Identifying and implementing enhanced AML measures across Broking & Depository business...

In this role at Piramal Agastya, your primary responsibility is to ensure compliance with regulatory and Pharmacopoeial standards through compendia assessments, Quality Management System (QMS) oversight, and documentation preparation. You will collaborate with global sites, vendors, and internal teams to develop quality agreements and provide support during audits and inspections. Additionally, you will be managing SOPs, monitoring QMS events, and preparing essential quality documentation and reports. As part of your responsibilities, you will: - Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitiga...

Role Overview: As the Principal Investigator (PI) based in Noida, India, you will oversee the scientific, ethical, and regulatory aspects of clinical trials. Your crucial responsibilities include ensuring participant safety, protocol adherence, and data integrity throughout the trial process. Collaboration with sponsors, regulatory authorities, and internal teams will be essential to achieve successful trial outcomes. Key Responsibilities: - Serve as the lead medical expert for assigned clinical trials - Ensure compliance with ICH-GCP guidelines and local regulatory requirements - Oversee patient recruitment and informed consent processes - Document and report adverse events - Participate in...

Role Overview: As a dedicated team member in the sterile manufacturing department, your primary responsibilities will include attending and ensuring compliance with training sessions as per the training schedule and Training Needs Identification (TNI). You will be expected to adhere to the standard operating procedures to maintain the highest quality standards in the manufacturing process. Your role will involve the meticulous preparation, review, revision, and control of Standard Operating Procedures (SOPs) for the General Area within the Sterile Manufacturing Department. Additionally, you will be responsible for the preparation of Batch Production Records (BPR) and the validation and calib...

Role Overview: As a Compliance Manager at our organization, you will play a crucial role in ensuring adherence to all applicable laws, regulations, and internal policies. Your responsibilities will include formulating project plans that guarantee compliance with RBI, NPCI, and network guidelines. You will collaborate closely with various stakeholders from Business and Product teams to ensure a clear understanding and implementation of regulatory requirements. Staying updated with all regulatory developments and providing guidance to leadership on interpretation and implementation will be a key aspect of your role. You will actively contribute to driving the International compliance charter b...

Role Overview: As the Compliance IT at our organization, you will report to the Head of Regulatory and Compliance. Your main responsibility will be to oversee regulatory inspections and manage IT compliance. You will also conduct Information Systems Audits for the Bank, which includes evaluating Information Systems and Security audits, application control reviews, and application functionality reviews. Additionally, you will execute IT audits according to the annual audit plan and support team members in performing compliance reviews. Your role will also involve contributing to the preparation of regular submissions to the Board and Audit & Compliance Committee. Key Responsibilities: - Overs...

As the Lead-Compliance-Retail Assets in the Compliance department, your role involves providing advisory on regulatory expectations to Retail Assets, Credit Cards, and Shared Services business units. You will be responsible for coordinating and collating ad-hoc/indent requirements with business stakeholders, reviewing policies, SOPs, and manuals based on regulatory circulars and advisory perspective. Additionally, you will coordinate during RBI Examination exercise closure of regulatory obligations, manage stakeholders during Regulatory Inspections and data collation, assist the Regulatory compliance team with Ad-hoc requirements and preparation of various Board related notes, and provide ef...

As a Validation Specialist at our company, your primary responsibility will be to plan, execute, and document analytical method validation activities for raw materials, in-process samples, finished products, and cleaning validation. This will involve assessing various parameters like accuracy, precision, specificity, linearity, robustness, LOD/LOQ, and others. You will also review and approve validation protocols and reports to ensure compliance with ICH Q2(R1), USP, and other regulatory standards, maintaining adherence to GMP, GLP, and cGMP guidelines. Your role will require collaboration with R&D, QA, and Production teams to facilitate seamless tech transfer and validation support. Trouble...

JOB PROFILE OF EXECUTIVE QAC Educational Qualification : Graduate / MSC Chemistry Designation : Executive - QA Preferred Profile: Knowledge & Experience in : Compliance with GMP, SOPs, Review the quality of raw materials, packaging materials, and finished products and IPQC activities. Experience : Minimum 3 to 4 Years CTC : 3L to 4L PA Industry : FMCG (Except food industry) Location : Bangalore (Location - Doddaballapur) Contact : Mohanraj 9176601438, mohanraj.s@avacare.in Job Description Ensure compliance with GMP, SOPs, and regulatory requirements in all QA processes. Monitor and review the quality of raw materials, packaging materials, and finished products. Lead root cause analysis and c...

As a Regulatory Compliance professional, you will be responsible for handling Regulatory Compliance related to third-party products (insurance, mutual fund etc.) distribution business of the Bank. Your role will involve ensuring compliance with various regulations from SEBI, IRDA, AMFI, and other regulatory bodies. Key Responsibilities: - Strategically manage Regulatory Compliance for the Bank, covering regulations from SEBI, IRDA, AMFI, etc. - Handle Compliance with regulations related to Mutual Fund & Insurance Distribution Business of the Bank. - Circulate action points from regulatory circulars/notifications/communications and follow up proactively with stakeholders for timely implementa...

As an Engineering Stores - Executive at Teva Pharmaceuticals, you will play a crucial role in ensuring the smooth functioning of the engineering department. Your responsibilities will include the following: - Overall management of engineering activities, including monitoring and review of procedures and cGMP records in the engineering store to ensure compliance. - Preparation and review of Engineering store SOPs in Glorya Electronic Data Management System. - Ensuring readiness of the department for regulatory inspections and compliance with regulations. - Upkeeping of engineering store compliance and initiation/execution of Change Controls, Deviations, Investigations, CAPAs in Trackwise Syst...

Role Overview: As a Maintenance Manager at Native, you will play a crucial role in ensuring the optimal functioning of all plant machinery, utilities, and infrastructure. Your primary responsibility will be to develop and implement preventive maintenance schedules, troubleshoot breakdowns, and manage spare parts inventory to minimize downtime and support production continuity. Key Responsibilities: - Develop and implement preventive maintenance schedules for assembly lines and support equipment - Troubleshoot breakdowns and coordinate quick resolution - Maintain utilities including HVAC, compressors, water systems, and electrical panels - Manage spare parts inventory and vendor coordination ...

Role Overview: You will be responsible for providing advisory on regulatory expectations to Retail Assets, Credit Cards, and Shared Services business units. Your role will involve coordinating with various stakeholders, reviewing policies and manuals, and ensuring regulatory compliance. Key Responsibilities: - Coordinating and collating ad-hoc/indent requirements in collaboration with business stakeholders. - Reviewing policies, SOPs, manuals, etc., from regulatory circulars and advisory perspective. - Coordinating with officials during RBI Examination exercise for closure of regulatory obligations. - Coordinating with stakeholders during Regulatory Inspections and collation of data. - Assis...

Assist in Board and Committee Meetings for drafting of notice, agenda and minutes. Ensure timely filing of ROC and NHB returns Support in drafting, reviewing and maintaining statutory registers, resolutions and policies Liaise with regulators (MCA, NHB and RBI) for various submissions Assist in Secretarial audit, regulatory inspections, due diligence, and internal audits Role & responsibilities Preferred candidate profile

Job Description : Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office At Thermo Fisher Scientific Inc., we are seeking an ambitious and dedicated QA professional for the position of band 3 (direct labour). This role is pivotal in our mission to maintain world-class quality standards and ensure flawless operations. Join us and be part of a team that is determined to make a difference! Responsibilities Manage material receiving, destruction, in-process quality assurance (IPQA), and return activities Perform and conduct quality checks (IPQA) at decided intervals during packaging production Maintain the Archival A...

Role & responsibilities Manage regulatory audits and inspections Respond to regulatory queries Internal Audit Report co-ordination and submission Co-ordinate with various depts for data Improve the Compliance framework of the company Responsible for the Internal Audit report preparation and submission Responsible for Off-site, onsite and AP audits and inspections. Regulatory interaction and reporting. Timely submission of IAR Preferred candidate profile Good understanding of MS Office and inter departmental co-ordination Graduate in commerce or law or CS Interested candidates can share theior updated resume on swapnali.mendonca@sharekhan.com

Job Summary: As a Validation Compliance GxP Consultant, you will be responsible for overseeing and managing the validation processes of systems, processes, or products to ensure compliance with industry standards and regulations. You should have extensive experience in system validation, quality assurance, and compliance management, with a focus on meeting regulatory requirements and operational efficiency. Key Responsibilities: You will lead and manage system validation activities for projects to comply with regulatory standards such as FDA, GMP, ISO, and 21 CFR Part 11. Developing and executing validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes is a key part of...

As a Drug Regulatory Affairs Specialist at MEDYUR PHARMACEUTICALS LIMITED, you will be responsible for ensuring compliance with regulatory requirements for our products. Your role will involve collaborating with cross-functional teams to drive successful product launches and maintain regulatory compliance. Your responsibilities will include preparing and submitting regulatory documentation, staying updated on global regulatory requirements, developing relationships with regulatory bodies, reviewing changes in regulatory policies, conducting regulatory impact assessments, maintaining regulatory files, and supporting regulatory inspections and audits. You will also collaborate with internal te...

As the Head Risk and Regulatory Officer for our leading International Exchange located in Ahmedabad / Gandhinagar, you will be responsible for leading the Risk and Regulatory Team. Your key duties will include providing guidance, coaching, and assistance to the team members. You will collaborate with other Key Management Personnel to integrate Regulatory Compliance into business plans and operations. In this role, you will oversee the protection of the risk department's information technology and risk monitoring operations. You will also be in charge of presenting risk policies and regulatory initiatives to the board, regulators, and other stakeholders. Additionally, you will manage the risk...

Join our team to lead the implementation of AML and anti-corruption initiatives in India. You will work closely with business and compliance teams to ensure adherence to firm policies and local regulations. As the Compliance Risk Management Lead in the CCOR team, you will be responsible for implementing the firm's AML and anti-corruption program in India for the Corporate and Investment Banking businesses. You will collaborate with business, location Compliance, and Line of Business Compliance to ensure programs are aligned with firm policies, standards, and local laws. Your responsibilities will include implementing the India AML program, conducting risk assessments and trainings, assisting...

We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, a...

As an Audit Quality Control and Risk Management Director at Weaver, you will be responsible for performing audit engagement quality reviews for investment fund engagements. Your primary objective will be to ensure full compliance with professional standards and firm guidelines. Moreover, you will play a crucial role in overseeing and enhancing the firm's audit methodology and tools specific to hedge funds, private equity funds, venture capital funds, mutual funds, and other pooled investment vehicles. Your expertise will drive continuous improvements in risk assessment, documentation quality, independence, and ethics compliance. The ideal candidate for this position should possess a Bachelor...