196 Regulatory Audits Jobs

Role & responsibilities Collate/Maintain catalogue of regulatory requirements applicable to Internal Audit (IA) function Ascertain the actionable for IA function and Assess IAs compliance with regulatory requirements/expectations Assess IA’s readiness for regulatory inspections Handle/Manage regulator’s asks from IA function during inspections coordinating with Compliance function as IA’s SPOC Manage/Execute snap audits on new/key regulations to assess organisation’s compliance with regulatory requirements Identify triggers / risk hotspots related to compliance risk Conduct unplanned audit reviews based on directives received from regulators, board committees Identify and develop automated t...

Co-ordination & Ensuring timely execution of Sampling activity of Raw and Packing materials. Preparation, Review and updating of standard operating procedure. To ensure line clearance for dispensing, sampling and packing activity. Routine monitoring of all functional area to ensure adherence to the SOPs. Create signature and methods for raw materials by using Truscan RM analyzer. Approved / Rejected labels affixing for API, Excipients, Primary packing and secondary packing materials finished goods and operation supplies. Verification of Temperature and Relative Humidity reports generated from TESTO software. To perform the QMS (change control) activities as per access approvals. To perform n...

JOB DESCRIPTION: Primary Job Function: TPM's supplying to Biosimilars in India and APAC region Quality Oversight of TPM's QMS Management at TPM's Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility Investigations of Products failures, OOS, Complaints pertaining to Abbott products Review of APQR's GMP compliance at TPMs. Compliance to Abbott procedures and policies. Core Job Responsibilities: Responsible and accountable for the oversight of quality operations and GMP compliance across the TPM's under responsibility of EPD Biosimilars Operations in India. Effectively monitoring the rating of responsible TPM sites. Leading the implementation of quality st...

In this role as a Quality Assurance professional, you will be responsible for the review and approval of Supplier Qualification documents, such as NSQR, VQ Documents, etc., from Raw material / Packing material manufacturers and external service providers. Your key responsibilities will include: - Preparing and distributing corporate approved supplier lists, New product tentative approved supplier lists, and Tentative approved supplier lists to all SQAs. - Providing support to site QA for regulatory audits and Customer audits. - Reviewing vendor notifications and coordinating with RA & SCM for further requirements. - Reviewing delist declarations from SCM and coordinating with RA & Site QA te...

In this role at Ajanta Pharma, as the Site Quality Head (Sr. General Manager Quality) for the Guwahati formulation plant, your primary responsibility will be to lead the Quality Assurance and Quality Control functions. You will play a crucial role in ensuring regulatory compliance and maintaining high-quality standards at the site. **Key Responsibilities:** - Lead the Quality function encompassing both Quality Assurance and Quality Control departments at the Guwahati site to ensure adherence to internal standards and external regulatory requirements. - Develop and implement robust Quality Systems aligned with cGMP, GxP, and relevant regulatory guidelines such as WHO, CDSCO, etc. - Supervise ...

Job title Quality Management System (QMS) Manager Reports to Operation Head Job purpose : Establishment, implementation, and continuous improvement of the company's. Quality Management System (QMS) to support its clinical-stage biopharmaceutical development programs while ensuring compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH) and GxP standards (GMP, GDP, GCP, GLP). Cross-functional collaboration to embed a proactive quality culture, align GxP activities with corporate quality objectives, and drive operational excellence as the organization advances toward late-stage and commercial readiness. Duties and responsibilities QMS Development & Implementation Develop, impl...

Role Overview: You will be leading the Quality and Regulatory department of the API and Intermediate business at LOXIM. Your primary focus will be on ensuring quality, compliance, and global regulatory excellence, with a hands-on approach. You are expected to align with cGMP, ICH, and international regulatory standards, strengthen systems, people, and culture. Your deep understanding of API and intermediate processes, global filing requirements, and ability to guide teams through audits, inspections, and technology transfers will be crucial. Key Responsibilities: - Lead QA, QC, Regulatory Affairs, and Compliance functions at all manufacturing sites. - Ensure alignment with cGMP, ICH Q7, and ...

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

Role Overview: As the Head of Risk & Compliance for a leading NBFC, you will be a key member of the leadership team reporting directly to the Board/Designated Director. Your main responsibility will be to ensure end-to-end compliance with various regulatory requirements such as RBI, FIU-IND, PMLA, SEBI/IRDAI, and to oversee enterprise-wide risk management and governance in the digital financial services portfolio. You will also serve as the Principal Officer (PO) for the company and will be required to liaise with regulators and design/implement various compliance programs. Key Responsibilities: - Manage end-to-end compliance with regulatory requirements (RBI, FIU-IND, PMLA, SEBI/IRDAI) - Ov...

In this role at GetVantage, you will be responsible for managing legal, compliance, and secretarial functions within the fintech/NBFC business. Your main duties will include contract management, regulatory compliance, corporate governance, and supporting strategic transactions. Key Responsibilities: - Draft, review, and negotiate various contracts such as loan agreements, vendor/SaaS contracts, NDAs, and partnership agreements. - Offer legal advice on lending products, co-lending, securitization, and debt instruments. - Handle disputes, litigation, and enforcement proceedings effectively. - Ensure adherence to RBI regulations, digital lending guidelines, KYC/AML norms, data privacy laws, and...

As a Business Development and Project Management professional with 10 to 15 years of experience, your primary responsibilities will include: - Generating monthly/quarterly and annual revenue in alignment with set targets and annual budget. - Acquiring new customers, exploring new regions, and expanding into other business verticals. - Cultivating and nurturing relationships with key stakeholders such as clients, partners, and industry influencers. - Keeping abreast of industry trends, market dynamics, and competitor activities to spot opportunities for innovation and growth. - Managing credit control and monitoring receivables effectively. - Assessing the feasibility of studies, preparing pr...

As a competent candidate for the role in Risk and Compliance at a leading NBFC, you will be a key member of the leadership team reporting directly to the Board/Designated Director. Your primary responsibilities will include: - Serving as the Principal Officer (PO) for the company - Managing end-to-end compliance with regulatory requirements from RBI, FIU-IND, PMLA, SEBI/IRDAI - Overseeing enterprise-wide risk management and ensuring strong governance in the digital financial services portfolio - Maintaining effective communication and relationships with regulators such as RBI, FIU-IND, IRDAI, SEBI, and any other relevant authorities - Designing and implementing programs related to KYC/AML, t...

As a QA/QC Manager at our company, you will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your role will involve the following key responsibilities: - Preparation, review, and implementation of SOPs and STPs. - Checking of all QC related records like analytical reports and logbooks. - Planning and distribution of samples for analysis of Raw Materials, Intermediates, and finished products. - Designing and conducting Stability studies as per ICH Guidelines. - Developing and validating analytical testing methodology used to control raw materials, production intermediates, and final products. - Preparation and ma...

As a Quality Assurance GLP professional at MSCR, your role involves ensuring the highest standards of quality and compliance across clinical research and laboratory operations by leveraging your expertise in ICH-GCP and GLP principles. You will be responsible for various key activities: - Develop and maintain ICH/GCP-compliant processes at MSCR. - Lead internal quality audits, CAPA activities, and quality management reviews. - Conduct study audits to ensure adherence to sponsor protocols, GCP, and regulatory requirements. - Identify non-conformances, recommend corrective measures, and drive continuous quality improvements. - Perform vendor audits, collaborate with production support teams, a...

As a QC Chemist/Analyst, your role involves performing a variety of tasks related to quality control and analysis. Your key responsibilities will include: - Sampling of raw materials, packaging materials, intermediates, and finished products as per Standard Operating Procedures (SOPs). - Conducting chemical, physical, and instrumental analysis using methods such as UV, IR, and KF as per pharmacopeia or in-house validated methods. - Analyzing water, stability, and environmental monitoring samples. - Maintaining Good Laboratory Practices (GLP) and ensuring compliance with cGMP guidelines. - Preparing, reviewing, and maintaining accurate test records, logbooks, Certificate of Analysis (COAs), a...

Job Family BICM Process (India) Travel Required None Clearance Required None What You Will Do Lead and manage a team of associates, ensuring consistent delivery of controls testing across assigned projects Drive achievement of Service Level Benchmarks including Productivity, Quality, and Turnaround Time (TAT) Oversee execution of controls testing activities in accordance with internal processes, regulatory requirements, and client-specific standards Ensure compliance with internal controls, external regulations, and audit readiness Identify control gaps and lead process improvement initiatives to enhance risk management and operational efficiency Collaborate with cross-functional teams acros...

Hands-on experience in GMP-compliant manufacturing environment Exposure to regulatory audits (e.g. USFDA, MHRA, WHO). Deep understanding of GMP, ICH guidelines, and local / international regulatory requirements Skilled in preparing for and facing customer audits. Root cause analysis, CAPA implementation, and continuous improvement Familiarity with QMS software, oracle, SAP, Minitab, LIMS, and other electronic documentation systems. Involvement in quality systems: deviations, CAPA, change control, and batch release Experience in document control & validations Managing QA teams, mentoring staff, and cross-functional collaboration

As a member of the Central Quality department, your role involves: - Conducting Vendor Audit & Compliances - Reviewing Procurement bill of material (PBOM) - Initiating and evaluating change control, Corrective and Preventive Actions (CAPA) through track wise software - Evaluating Certificate of Suitability (CEP) updation, Drug Master File (DMF) notification, and Vendor notification for implementation at formulation sites - Reviewing Quality Management System (QMS) documents of all sites - Auditing formulation sites as per self-inspection plan - Preparing Audit planner for Active Pharmaceuticals Ingredients, Excipients, packing materials, Key Starting Materials (KSM)/Intermediates, Sterile ar...

Role & responsibilities * Bio burden testing of in process samples as per the BET testing of water samples, in-process samples, semi-finished and finished samples as per the specification. * Sterility testing of finished product. water samples. * Maintenance and handling of Endotoxin indicators and biological indicators. * Experience on culture maintenance and VITEK2 compact system and Sterility. • Injectables or biologics experience is mandatory. * Regulatory audits exposure is mandatory.

Job Summary We are seeking an individual to oversee batch manufacturing, ensuring adherence to cGMP (Current Good Manufacturing Practices), providing training, and coordinating day-to-day activities. Responsibilities include minimizing machine downtime, managing subordinate staff, assuring compliance with standards and SOPs (Standard Operating Procedure), leading regulatory audits, compiling reports, ensuring safety norms, and budget management. Roles & Responsibilities • You will be responsible for enforcing cGMP for batch manufacturing in order to obtain high-quality products and achieve targeted production within a span of control. • You will be responsible for imparting general and cGMP ...

As a Senior Associate Compliance at Carelon Global Solutions India, your role will involve proactively collaborating with Elevance Health to support regulatory and compliance related activities. You will drive efficiency, automation, and innovation across the organization while ensuring standardization and adoption of best practices. Your responsibilities will include understanding contracts, researching U.S. based regulations, comprehending report submission requirements, and providing senior level analytical support to projects, initiatives, regulatory audits or exams, internal audits, and risk assessments. Additionally, you will be expected to apply critical thinking to formulate strategi...

**Job Description:** As a Regulatory Audits Support Specialist, you will be responsible for collecting relevant data from each respective team to support data collection for regulatory audits. Your role involves validating the collected data to ensure it addresses the audit request. In case any regulatory request is not on target, you will escalate the issue to your supervisor. **Key Responsibilities:** - Collect relevant data from each team for regulatory audits - Validate the collected data to address audit requests - Escalate any regulatory requests that are not on target In the role of Vulnerability Management Specialist, you will ensure that all vulnerability management activities are c...

Job Summary We are seeking an individual to oversee batch manufacturing, ensuring adherence to cGMP (Current Good Manufacturing Practices), providing training, and coordinating day-to-day activities. Responsibilities include minimizing machine downtime, managing subordinate staff, assuring compliance with standards and SOPs (Standard Operating Procedure), leading regulatory audits, compiling reports, ensuring safety norms, and budget management. Roles & Responsibilities • You will be responsible for enforcing cGMP for batch manufacturing in order to obtain high-quality products and achieve targeted production within a span of control. • You will be responsible for imparting general and cGMP ...

Handling of Change control, Handling of Deviation and CAPA management system, Handling of Internal and external audits, Sound knowledge about Equipment and Utilty qualifcation, Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. Should have experience of regulatory audits.

Huntsman Corporation is now looking for a dynamic individual as a Corporate Internal Auditor. Huntsman Corporate Internal Audit practices generally conforms with International Standards for the Professional Practice of Internal Auditing (IIA Standards) and adopts innovative and leading practices. As part of the Asia Corporate Internal Audit team based in Petaling Jaya, you will travel to various Huntsman sites throughout the Region to participate and/or lead various financial and operational audits. The role gives a unique insight into how the business operates internationally across all functions. With high level of exposure to various levels of management, the right candidate will get the ...