196 Regulatory Audits Jobs - Page 6

Sr Internal Auditor with Data Analytics to lead & execute audits across India & Asia supporting the global internal audit team. This role will be based from our Technology Center in Bangalore but will call for both national & international travel. Required Candidate profile Certified Internal Auditor CIA 5+ years of experience in internal auditing, with a focus on data analytics. Proficiency in data analytics tools such as ACL, IDEA, SQL, or Python. financial principles

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also inclu...

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in ...

Role & responsibilities Asst. Manager (Regulatory Affairs) 1. The Candidate must be M.Sc or B.Pharma or M.Pharma with 7-12 years of experience out of which minimum 3-4 years in regulatory affairs in EU, US markets, WHO GMP certified pharmaceutical formulation company. He will be responsible for all regulatory functions- domestic as well as exports. He will coordinate with other departments on regular basis. He will provide documentation support required for regulatory submission independently, including preparation and submission of dossiers for product and plant registrations in different countries as per latest guidelines. Exposure to Regulatory Audits & QMS system. Knowledge of Drug & Cos...

You should have over 15 years of experience in Warehouse operations, including at least 7 years in a supervisory role within injectable manufacturing. Your role will require a strong understanding of regulatory requirements, cGMP, and industry best practices. You should possess proven leadership abilities and excellent communication skills to effectively work cross-functionally and resolve quality-related challenges efficiently. Previous experience in successfully facing regulatory audits, including USFDA, EU-GMP, and ANVISA is mandatory. In terms of Material Receipt and Storage, you will be responsible for ensuring that all materials are stored and handled in compliance with cGMP and regula...

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corp...

Role & responsibilities Lead Audit Engagements: Lead and execute complex internal audit engagements in accordance with the annual audit plan and professional auditing standards (e.g., IIA standards), ensuring timely completion and high-quality deliverables. Risk and Control Assessment: Rigorously review and evaluate financial, operational, and compliance processes, identifying critical risks and assessing the design and operating effectiveness of internal controls across various business units. Procure-to-Pay (P2P) Process Review: Oversee and conduct in-depth reviews of end-to-end Procure-to-Pay (P2P) processes, including purchase requisitions, orders, goods receipt notes (GRNs), and vendor ...

Title: Block Head (Parenteral Production) Job Grade: G8 Deputy General Manager Educational Qualification: B.Pharm / M.Pharm Location: Baska, Gujarat Experience: Knowledge of parenteral manufacturing operations Understanding regulatory guidelines Leadership & Team Management Skills Problem Solving & Decision-Making Proficiency in handling production documentation & compliance Min. 15 years of experience working in sterile manufacturing plant or Block In-charge experience Position Summary Responsible for plant operations from material procurement to product dispatch along with operational activities, manufacturing actions, lean management, training, regulatory compliance, cross functional coor...

As a Manager-II in the MSTG department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to provide support for the execution and monitoring of trial, scale up, exhibit process qualification batches. You will be involved in preparing and reviewing new product documents such as material requirement sheet, master formula card, bill of material, master formula, risk assessment reports, sampling protocol, reports, exhibit batch manufacturing record, and exhibit protocols. Additionally, you will be required to prepare regulatory responses and share process knowledge with cross-functional departments through presentations for smooth technology transfer. You will play a key ...

Role & responsibilities 1. Laboratory Management Lead & supervise all QC lab functions include chemical, instrumental, microbiological testing. Ensure timely and accurate analysis of raw materials, intermediates, APIs, packaging materials. Maintain and calibrate analytical instruments (HPLC, GC, FTIR, UV-Vis, etc.). 2. Compliance and Regulatory Ensure full compliance with cGMP, ICH guidelines, and all relevant regulatory requirements. Prepare for and lead regulatory and customer audits (USFDA, MHRA, EDQM, WHO, etc.). Manage CAPA, OOS, OOT, deviations, and change control processes. 3. Documentation and Quality Systems Oversee preparation and review of all QC-related SOPs, protocols, reports, ...

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 equipme...

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical ...

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

You will be joining HP & ASSOCIATES LLP, Chartered Accountants, a professional services firm that specializes in Audit, Tax, and Advisory services. As part of our dynamic team, you will have the opportunity to work on a wide range of projects that aim to create, preserve, and transform value for our clients. We take a sector-first approach to ensure that our clients receive high-value solutions that help them adapt seamlessly to industry changes. In this full-time, on-site role based in Mumbai, you will be participating in a CA Articleship program at HP & ASSOCIATES LLP. Your main responsibilities will include assisting in audits, tax preparations, financial reporting, and compliance checks....

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary docume...

As a Senior Manager - Stores at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, IN, you will be responsible for overseeing API & Formulation Stores functions. Your duties will include managing RM/PM receipt, storage, material issuance, dispatch, as well as ensuring compliance with regulatory audits such as USFDS, EDQM, PMDA. You will also be in charge of maintaining QMS related documents, statutory requirements of MA-1, MA-2, RS-2, AC-2, DS-5, and handling monthly, quarterly, and yearly returns. Additionally, you will be responsible for inventory planning, stock requirements, material movement, hazardous material handling, and tanker unloading. This role requires a strong understa...

Role & responsibilities - Develop and execute a risk-based internal audit plan in alignment with IRDAI regulations and business priorities. Lead the internal audit team and manage relationships with external auditors and consultants. Conduct audits across operational, financial, IT, and regulatory domains. Present audit findings and risk insights to Senior Management and the Audit Committee . Monitor implementation of audit recommendations and ensure timely closure of control gaps. Drive automation and continuous control monitoring using data analytics and audit tools. Provide advisory support to business units on control design and risk mitigation.

This Opportunity is with a leading NBFC company for their office in Chennai location Role: Compliance Manager Experience: 5 - 10 Years Job Description: Roles & Responsibilities: Assist in conducting process reviews and identifying gaps in risk and compliance controls Monitor and interpret relevant RBI regulations, circulars, and guidelines for applicability Support the preparation and maintenance of compliance-related documentation and internal policies Collaborate with internal departments to ensure understanding and implementation of regulatory requirements Coordinate with auditors during internal and regulatory audits Required Skillset: Understanding of RBI regulations for NBFC or banking...

As a Senior Compliance Manager at Suncrypto, a top 5 Crypto Exchange in India, you will be responsible for leading the compliance and AML functions of the company. With 5-7 years of experience in Regulatory Compliance, AML, and Financial Crime Risk Management, you will play a crucial role in ensuring Suncrypto's adherence to all compliance frameworks applicable to Virtual Digital Asset Service Providers (VDASPs) in accordance with FIU-India guidelines, PMLA, FATF recommendations, and other regulatory requirements. Your key responsibilities will include developing and implementing AML, KYC, and Transaction Monitoring policies, overseeing FIU-India reporting, and handling compliance obligation...

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits a...

As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. Your role will involve completing all assigned mandatory trainings related to data integrity, health, and safety measures on time, and ensuring compliance to quality systems and current good manu...

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Ba...

You will be joining HP & ASSOCIATES LLP, Chartered Accountants, a leading professional services firm specializing in Audit, Tax, and Advisory services. As a CA Articleship candidate based in Mumbai, you will play a crucial role in supporting audits, tax preparations, financial reporting, and compliance checks. Your responsibilities will involve handling direct and indirect taxes, corporate finance, IT advisory, and risk management services. Additionally, you will participate in regulatory audits and advisory services, demonstrating professionalism and precision in meeting diverse client requirements. To excel in this role, you should be enrolled in the CA Articleship program with IPCC certif...

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing. Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR). Conduct in-process checks and ensure batch release activities. Required Candidate profile Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.). Review of analytical documents, stability protocols, validation protocols & reports. Immediate to 30 days preferred

Panacea Biotec believes in providing opportunities for "Better Health to Live Well and Live Longer". As one of India's leading Pharmaceutical & Biotechnology Company, we have a strong foundation in Research, Manufacturing, and Brand Building. Our ultra-modern manufacturing facilities for Vaccines, Pharma & Nutrition are cGMP compliant, ensuring the production of high-quality products. Join us in making history by contributing to a company that introduces innovative brands that have positively impacted millions of lives worldwide! We are currently looking for a dynamic and experienced Head of Engineering and Projects to join our team. The ideal candidate will be responsible for overseeing all...