257 Regulatory Audits Jobs

Roles and Responsibilities Ensure compliance with regulatory requirements such as GMP, CGMP, USFDA, MHRA, GLP, and WHO guidelines. Conduct audits to identify deviations and implement corrective actions to maintain regulatory compliance. Manage BMRs (Batch Manufacturing Records) and ensure accurate documentation of manufacturing processes. Develop and implement effective compliance management systems to prevent non-conformities. Collaborate with cross-functional teams to resolve issues related to product quality, safety, and regulatory affairs.

Lead overall plant operations including Production, QA, QC & Engineering. Ensure cGMP compliance, regulatory readiness, people leadership, cost optimization, EHS adherence, and timely execution of plant expansion and improvement projects. Health insurance Annual bonus Provident fund

1-Understanding of regulatory requirements 2-Must Have Knowledge in regulation of Class I, II and III medical devices 3-Exp in regulatory affairs within the medical device industry. Interested candidate can directly apply on recruit@shalya.in

As a Quality Assurance Manager for the Pharma Vertical at Cotecna Life Sciences India Pvt Ltd. (Erstwhile Geochem Laboratories), your role will involve the following responsibilities: - Establish, implement, and maintain the Quality Management System in alignment with current GxP activities, including ISO/IEC 17025:2017 standards. - Make independent and timely decisions related to GxP quality and compliance requirements. - Host and provide support during regulatory and customer audits. - Train and mentor staff on GxP regulations, manage GxP and ISO documentation systems, and oversee the training program. - Align Quality Assurance Standard Operating Procedures (SOPs) with guidelines and best ...

Title: Sr.Executive - API QC Custom Field 2: 2930 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Hands-on experience with HPLC, GC analysis, stability studies, QMS, change control, OOS, incident management, deviation handling, CAPA, and exposure to regulatory audits. Job Segment: CAPA, Law, QC, Quality, Legal, Management

**Job Description** As a Compliance professional at the company, you will have the opportunity to work in critical areas of Compliance, Governance for BharatPe with some of the brightest minds in the industry who are truly focused on building #bharatpeforbharat. **Key Responsibilities** - Maintain oversight of developments in the BFSI, Fintech regulatory environment. - Develop internal procedures to prevent money laundering. - Build new scenarios/rules, create BRDs, and evaluate exception reports and alert closures. - Evaluate the performance of AML monitoring tools and negative list screening. - Review policies and procedures in the AML program (KYC/CDD/EDD). - Ensure information consistenc...

Liability Operations Location: Noida Candidate has to be living or open to move to Noida at the time of joining the bank with family and children is a must. Experience: a. At least 15 years of experience in banking operations in overseeing and managing all operational activities related to liability products and branch operations such as savings accounts, current accounts, term deposits, NRE/NRO accounts, recurring deposits, CASA onboarding, and other customer-servicing functions b. Experience of working in Finacle Experience in managing regulatory audits Attributes: a. Ability to recruit and build team b. Ability to get hands dirty and be hand on c. Should be ready to take up, extensive tra...

As an experienced professional in the broking industry with over 10 years of experience, your key role will involve ensuring compliance with SEBI and other applicable rules and regulations of the stock exchanges like NSE & BSE, depositories, clearing corporations, and daily settlements. You will be responsible for various tasks such as return filing, client communications, monitoring operations, reporting, empanelment, liaising with the back office of institutional cum HNI clients, and other day-to-day back office work related to "Depository Participant and Stock Broking." Key Responsibilities: - Demonstrating excellent organizational skills, including time management, record keeping, self-s...

As an Associate Program Manager at our company, you will play a crucial role in managing technical programs with a focus on customer satisfaction. Your responsibilities will include: - Managing cybersecurity and regulatory audits, vendor due diligence, and VRR bank side onsite audits to ensure timely and successful completion - Utilizing your experience in handling cybersecurity and regulatory audits, IT risk management, or information security domains, with a preference for VAPT security reviews - Demonstrating a fundamental understanding of audit disciplines such as audit concepts, security controls, and auditing project management Qualifications required for this role include: - Holding a...

KRA: Develop, implement, monitor QC procedures Inspect products at various stages of production Analyze data to identify areas for improvement Handle customer complaints, Customer/ ISO/ 3rd party audits Supplier quality CAPA/ Root cause analysis Required Candidate profile Degree/ Diploma/ PG Diploma in mechanical 5+ years' experience in quality in industrial equipment/ abrasives/ auto component industry Ready to travel or relocate to Murbad, Kalyan, MH

We are seeking a detail-oriented and proactive Regulatory Officer to ensure compliance with all applicable regulatory standards. The candidate will be responsible for preparing regulatory submissions, maintaining documentation, coordinating across departments, and ensuring that company processes and products meet regulatory requirements. Key Responsibilities Prepare, compile, and submit regulatory dossiers and documents to authorities (e.g., CDSCO, FDA, BIS, pollution control boards). Manage product licensing, registration, and renewal processes. Maintain regulatory documentation, compliance records, and databases. Ensure all product labels, packaging, and artworks comply with regulatory nor...

Documentation and Record Keeping Quality Risk Management Batch Manufacturing Record preparation Process Validation Packaging Material Specification Annual Product Quality Review Batch card preparation Dossier preparation New drug application Audit Required Candidate profile Experience in ensuring compliance with cGMP guidelines Gender Female Location Batanagar , South 24 Parganas, Kolkata

Job Description About TaskUs: TaskUs is a provider of outsourced digital services and next-generation customer experience to fast-growing technology companies, helping its clients represent, protect and grow their brands. Leveraging a cloud-based infrastructure, TaskUs serves clients in the fastest-growing sectors, including social media, e-commerce, gaming, streaming media, food delivery, ride-sharing, HiTech, FinTech, and HealthTech. The People First culture at TaskUs has enabled the company to expand its workforce to approximately 45,000 employees globally. Presently, we have a presence in twenty-three locations across twelve countries, which include the Philippines, India, and the United...

Ensure compliance of finished goods with REACH, RoHS, FDA, EU 10/2011, GRS, EFSA & other global regulatory standards Prepare & manage MSDS, TDS, Regulatory Declarations & customer compliance document Approve raw materials from compliance perspective. Required Candidate profile Strong understanding of global and domestic regulations related to polymers and chemical Excellent communication & interpersonal skill Good at liaison with regulatory bodies & certification agencies

QA Head (OSD) Experience: 8-12+ years Qualification: B.Pharm / M.Pharm / MSc Location: Patancheru, Hyderabad, India Salary: 812 LPA Please send your resume/cover letter to [HIDDEN TEXT] Responsibilities Lead regulatory inspections including WHO-GMP, CDSCO, EU-GMP, PIC/S, MHRA, USFDA, and customer audits. Ensure full site readiness and drive timely closure of audit CAPA. Oversee implementation and monitoring of the Quality Management System. Review and approve deviations, CAPA, OOS, OOT, change controls, and market complaints. Supervise APQR/PQR preparation, review, and approval. Review and approve Master BMR/BPR, MFR, SOPs, validation protocols, and reports. Direct batch release processes, l...

As the Food Safety and Quality Lead for bakery and pastry production, your role is crucial in ensuring the highest standards of food safety, hygiene, and quality are maintained throughout the entire process, from raw material receipt to finished product delivery. **Main Responsibilities:** - **Food Safety System Development:** - Oversee and enhance food safety management systems for the kitchen. - Implement and uphold HACCP plans, ensuring effective management of all critical control points. - Keep food safety documentation and records accurate and up-to-date. - Prepare the kitchen/team for regulatory audits such as FSSAI, FDA, ISO 22000, and BRC. - Conduct root cause analysis for any arisin...

Role Overview: As an analytical chemist at Amneal, your primary responsibility will be to develop, optimize, and validate analytical methods using GC and GC-MS/MS for various sample matrices. You will perform routine and non-routine analysis of raw materials, intermediates, and finished products, interpret complex chromatographic data, and ensure accurate documentation and reporting. Additionally, you will be responsible for maintaining and calibrating GC and GC-MS/MS instruments, troubleshooting instrument and method-related issues, preparing SOPs, method validation protocols, and reports in accordance with regulatory guidelines, and collaborating with cross-functional teams including R&D, ...

Role Overview: 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. Your role will involve ensuring the highest quality standards for pharmaceutical ingredients in compliance with international regulatory bodies such as USFDA, WHO, and ICH-Q7A. With your background in MSc. (Organic Chemistry)/ MTech Chemical (Technology)/ BSc. (Chemistry) and 10-15 years of industry experience, you will be instrumental in maintaining compliance with GMP standards and regulatory guidelines. Key Responsibilit...

As a candidate for the mentioned position, your role will involve overseeing end-to-end upstream fermentation operations. This includes tasks such as media preparation, seed culture development, fermentation scale-up, and harvest. You will be responsible for optimizing microbial fermentation processes for high cell density and metabolite production, utilizing various microorganisms like bacteria, yeast, or fungi such as E. coli, Bacillus, Saccharomyces, and Streptomyces. It will be crucial for you to consistently achieve production targets in terms of volume, yield, quality, and timelines. In case of any process deviations, contamination, or yield drops, you will need to troubleshoot effecti...

As a Regulatory Affairs Manager, you will play a crucial role in developing and implementing global regulatory strategies to secure product approvals and market access in various regions such as FDA, EMA, MHRA, TGA, and Health Canada. Your responsibilities will include: - Serving as a CMC expert in managing Initial Submissions and Life cycle management activities for Global Regulatory across multiple markets and dosage forms including OSDs, Ophthalmic, Complex Injectable, and Liposomal Dosage forms. - Authoring high-quality CMC documentation such as Dossiers and Deficiency responses, ensuring technical congruency and regulatory compliance. - Leading cross-functional teams for new product dev...

You should have sound knowledge of OOS/OOT, Deviation, and Manufacturing investigation. Your exposure to Regulatory Audits and shopfloor processes will be crucial for this role. - Sound knowledge of OOS/OOT, Deviation, and Manufacturing investigation - Exposure to Regulatory Audits - Familiarity with shopfloor processes,

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.

You will be joining HP & ASSOCIATES LLP, Chartered Accountants, a professional services firm specializing in Audit, Tax, and Advisory services. As part of the dynamic team, you will have the opportunity to work on a wide range of projects aiming to create, preserve, and transform value for clients. The sector-first approach ensures high-value solutions for clients to adapt seamlessly to industry changes. - Assisting in audits, tax preparations, financial reporting, and compliance checks - Working on direct and indirect taxes, corporate finance, IT advisory, and risk management services - Involvement in regulatory audits and providing advisory services to clients - Maintaining a high level of...

Kindly note we are looking for candidates from stock broking company background. Role & responsibilities We are seeking a dynamic and experienced Senior Compliance Officer to join our Compliance team at GRD, a leading Indian stock broking firm. The successful candidate will be responsible for overseeing, managing, and ensuring that the firm adheres to regulatory requirements and internal policies, while proactively identifying and mitigating compliance risks. You will play a key role in advising senior management on regulatory matters and will be instrumental in shaping the compliance culture within the organization. Key Responsibilities: Regulatory Compliance: Ensure the firm complies with ...

Department: Engineering & Maintenance Location: Dahej SEZ 2 Experience Required: 8- 12 years (Pharma Engineering OSD & SVP) Key Responsibilities: Lead and supervise engineering operations and maintenance activities for both OSD (Oral Solid Dosage) and SVP (Small Volume Parenterals) facilities. Ensure availability, reliability, and optimal performance of all production equipment, utilities, and support systems. Plan and execute preventive and breakdown maintenance schedules for critical equipment (Granulators, Compressors, FBDs, Autoclaves, Vial/Ampoule filling machines, HVAC, Water systems, etc.). Oversee qualification, validation, and calibration of equipment and utilities in compliance wit...