196 Regulatory Audits Jobs - Page 5

Job Description We are seeking an experienced EMC Systems Engineer to join our IGT Systems team. This role is ideal for a compliance-focused professional with a strong background in medical device safety, EMC/EMI testing, and regulatory standards. You will lead EMC strategy development, risk management, and compliance activities, ensuring our products meet global regulatory requirements and maintain the highest standards of safety and performance. Job Responsibilities: Collaboratively co-create, define, execute, and maintain the EMC System strategy for IGT-S Systems as a part of the Norm Compliance Team IGT-S. Co-ownership of the System-level EMC Risk Management file, crafting and maintainin...

The Opportunity: Officer - Quality Control is responsible to perform Quality Control activities at AQAL. What we are looking for :- Responsible for Timely analysis of under test samples giving timely results Coordination with tollar for quality related issues and clarification Sampling and analysis for RM/Intermediate/Finished Goods. Ensure compliance of ATR. Assisting team in ISO implementation Knowledge of calibration, standard preparation, standardization and relevant documentation. Handling knowledge of HPLC,GC and wet analysis. Education: B. Sc. M. Sc. (Chemistry) Experience: 2-5 years of experience in Quality including cGMP, ISO and regulatory Audits Preferred Skills/Qualifications: Kn...

Roles and Responsibilities: Take end-to-end ownership over advisory and validation of residual risk issues Lead and execute formal risk reviews and assessments Review and challenge risk exception requests Collaborate with internal stakeholders to ensure remediation dependencies are captured and managed Identify and act upon opportunities to improve Risk Governance processes Participate in global and regional governance committees Act as a role model for Risk Excellence Interface Regulator Exams (RBI/IFTAS/SEBI/NPCI) Identify/Assess/Manage Risks against LRR and internal policies, and Track them to closure through Issue Management Experience Required: Bachelor's degree in Information Technolog...

As an In-Process Quality Assurance (IPQA) Specialist at Dermatouch, you will play a vital role in ensuring that all manufacturing, packaging, and formulation processes adhere to the highest quality standards. Your responsibilities will be essential in maintaining product integrity, ensuring compliance with regulatory guidelines, and guaranteeing that every batch of Dermatouch products meets stringent quality benchmarks. Your main duties will include conducting real-time quality checks during manufacturing, filling, and packaging processes, as well as ensuring adherence to Good Manufacturing Practices (GMP) and regulatory guidelines. You will also be responsible for monitoring and verifying r...

Role & responsibilities Comply of QMS in-line with USFDA 21 CFR part 820, CE (EUMDR), ISO 9001:2015, ISO 13485:2016, EN ISO 13485:2016 for Sri City plant). To review and update the Quality Management System as and when required. To promote awareness of regulatory and customer requirements throughout the plant through continuous interaction and ensure that Quality Management System addressing such requirements are followed. Ready for announced and unannounced audits at any time. Ensure QMS documents are updated and kept ready for ongoing customer audit & regulatory audit. Assist QA Manager in collecting documents and preparing MRM reports, MOM and follow-up of actions agreed upon. Ensure that...

Key Responsibilities: Warehouse Operations Leadership: Direct and supervise daily warehouse activities, including receiving, storage, material handling, dispatch, and documentation. Ensure that all operations align with company policies, cGMP (current Good Manufacturing Practices), and regulatory standards. Inventory Management: Oversee inventory control systems to maintain accurate stock levels, prevent shortages or overstock situations, and facilitate timely replenishment and movement of materials. Implement cycle counts, reconciliation, and develop strategies to minimize inventory discrepancies. Compliance and Documentation: Ensure all warehouse processes adhere to regulatory guidelines, ...

Meet Our Team As Company Secretary & Counsel, you will work alongside a tight knit group of highly talented professionals and top lawyers from across the globe handling all aspects of the legal, regulatory, corporate and compliance matters of the Company. Picture Yourself At Pega As Company Secretary & Counsel, you will be part the legal team advising a fast-paced, high-growth public software company on corporate, procurement, regulatory and legal matters, interacting with stakeholders spread across different geographies, while reporting into Head of Legal, India. What You&aposll Do At Pega Organize the periodic meetings of the Board of Directors, the Annual General Meeting, Board Circulars,...

Senior Labor & Employment lawyer India/APAC At ABB, we are dedicated to addressing global challenges. Our core values: care, courage, curiosity, and collaboration - combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to empower everyone to create sustainable solutions. Write the next chapter of your ABB story. This is a position with grade 10 This position reports to Regional General Counsel EMEA and Global Head of Labor & Law Motion Your role and responsibilities In this role, you will be offered the opportunity to share and influence the design and/or implementation of our Labor and Employment strategies to ensure that the ABB Motion business...

Role & responsibilities Coordination with different departments vise (QC, Manufacturing & QA) for material testing. Issuance and release as per the plan. Planning and reviewing of work force availability for material receipts, movements, sampling, Labeling, relocation & dispensing activities. Reviewing online documentation from all the areas. Initiating the material write- offs for the rejected as well as non-moving slow moving & expired materials with proper management approval and customs approvals and disposal as per SOPs. Coordinating with production Head and production planning department to execute daily production schedule requirements. Monitoring systems / team to follow as per the G...

About Business line/Function: Inspection and controls team is crucial team of Sharekhan. Various audit activities of Inspection and controls team are used for adequate control and due diligence on Authorised persons of share khan and Branches. Inspection and controls team ensure to control revenue leakage and fraudulent activities through various control measures. Business review: head the team of 11 staff members to Complete his Inspection and controls various activities. Overview of All departments activities by Sample check method Activities need to be discussed with Department heads for further clarification. Deviation, Duplication, Revenue leakage etc. observed need to be noted and esca...

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...

4+ Yrs of exp in Compliance audits,User Access Reviews,Data Analysis. Reviewing Access logs, Identifying discrepancies, Collaborating with DT & CDR teams to rectify access related issues. proficiency in data management & access management tools.

The Senior Specialist-IT Governance & Compliance, part of the Information Technology department, plays a crucial role in the IT Governance and Compliance Team of the bank. The primary focus of this role is on GRC control function, specifically Compliance & Regulatory reporting including Cyber KRI, TRANCHE, ICAAP, and more. Responsibilities include being the custodian of IT governance and IT process governance framework, handling regulatory audits and submissions, understanding indents from regulators, creating and updating IT policies, administering key IT processes such as incident management and policy exception management, reporting to Lead IT Governance, identifying improvements and brea...

The ideal candidate will be responsible for leading end-to-end upstream fermentation operations, which includes tasks such as media preparation, seed culture development, fermentation scale-up, and harvest. You will be required to optimize classical microbial fermentation processes to achieve high cell density and metabolite production using various microorganisms like bacteria, yeast, or fungi such as E. coli, Bacillus, Saccharomyces, and Streptomyces. It will be your duty to ensure that production targets in terms of volume, yield, quality, and timelines are consistently met. In cases of upstream process deviations, contamination, or yield drops, you will be expected to troubleshoot effect...

As the Senior Manager, BFSI Compliance Lending at PhonePe, you will play a crucial role in ensuring all functional units are guided during the development life cycle of new products and maintaining compliance with regulatory guidelines. You will be responsible for overseeing the compliance requirements set by regulatory bodies such as RBI and ensuring their implementation across various products on the PhonePe platform. Your role will involve working closely with business, legal, risk, and audit functions to provide expertise on regulatory compliance matters, assess compliance risks, and monitor the firm's compliance control environment. You will act as the Lead Compliance Officer for the Di...

You will be responsible for performing In-Process Quality Assurance (IPQA) activities on the shop floor at every stage of manufacturing and packing processes. This includes ensuring QA standards for clean room behavior and activities, reviewing batch processing records, and checking all documents related to manufacturing, packaging, and analysis reports before batch release. You will also be required to review documents, logbooks, and conduct IPQA for Dispensing, Manufacturing, Packaging, and Dispatch activities. As part of your role, you will review and control Standard Operating Procedures (SOPs), specifications, Batch Production Records (BPR) issuance, Master Formulae, and records. Additi...

The Production Packing Assistant Manager/Manager is responsible for overseeing day-to-day production planning and execution to ensure requirements are met. You will be in charge of supervising and evaluating the performance of production personnel, organizing workflow to meet specifications and deadlines, and distributing staff/workers according to production planning. Additionally, you will review, approve, and implement departmental SOPs in accordance with current guidelines. You will also be responsible for monitoring online documentation such as BMRs, BPRs, log books, and other relevant documents. Monitoring the stage-wise process for product yield, reviewing QMS documents, qualification...

You will be responsible for supervising and guiding the IPQA team to conduct real-time monitoring during manufacturing and packing processes. Your role will involve ensuring compliance with BMR/BPR review and approvals at each stage, as well as overseeing line clearance before manufacturing and packaging activities. It will be essential to monitor critical process parameters, in-process checks, and control sampling activities including IPC, stability, validation, etc. You will be expected to ensure timely review and approval of executed batch records and logbooks, review and ensure compliance of standard operating procedures (SOPs), and maintain and control GMP documentation related to IPQA ...

The Regional Security Manager (RSM) is responsible for delivering effective and efficient physical security operations and programs that protect critical infrastructure for a complex, multi $100M global client account. You must be comfortable working in a highly complex, fast-paced, and collaborative culture. Managing a team of Campus Security Managers (CSMs) and Security Team Managers (STMs) in geographically separated facilities, you will verify compliance with security procedures and policies, track audit readiness, and provide direction to ensure physical security requirements are met or exceeded. Reporting to the Regional Director of Security Operations, you will work directly with mana...

As a Corporate Quality Assurance (QA) professional at Alembic Pharmaceuticals in Mumbai, your primary responsibility will be to ensure the effective implementation of Quality Management System (QMS), adherence to regulatory standards, efficient vendor management, and maintenance of product quality standards across various sites. Your key responsibilities will include managing QMS processes such as deviations, change control, investigations, and Corrective and Preventive Actions (CAPA). You will be entrusted with handling FDA and market complaints, ensuring their timely closure. Additionally, you will oversee the qualification/requalification of vendors for raw materials and packaging materia...

As a Quality Control Technician III at TAPI, you will be an integral part of the leading international supplier of active pharmaceutical ingredients (APIs). TAPI boasts the industry's broadest portfolio, which includes over 350 API products. With a rich history spanning over 80 years, we are recognized as one of the most trusted API suppliers globally, catering to 80 PERCENT of the top 50 pharmaceutical companies. At TAPI, our commitment to excellence is driven by our experience, expertise, cutting-edge technologies, and unwavering dedication to exceptional customer service. Your primary responsibilities will include maintaining 24/7 audit readiness, possessing expertise in Wet Chemistry, an...

To perform in-process quality assurance (IPQA) activities on the shop floor throughout all stages of manufacturing and packing. Conduct quality assurance oversight for clean room behavior and activities. Review batch processing records to ensure compliance with quality standards. Inspect all documents related to manufacturing, packaging, and analysis reports before batch release. Assess documents and logbooks in respective areas for adequacy and completeness. Monitor the receipt of materials from the warehouse to production area. Conduct IPQA for dispensing, manufacturing, packaging, and dispatch activities. Manage and control Standard Operating Procedures (SOPs), specifications, Batch Produ...

As an Audit Assistant at our organization, you will play a crucial role in supporting audit engagements in the United States. Your primary responsibility will be to collaborate with the audit team to ensure the accuracy and completeness of financial statements and related documentation. This is an excellent opportunity for you to gain exposure to audit processes, financial regulations, and client interactions. Your key responsibilities will include: Planning and executing audits by establishing audit plans, performing risk assessments, executing audit procedures, and reviewing documents and transactions. Evaluating internal controls by assessing control systems, identifying weaknesses, and t...

Job Description We are hiring a Senior Regulatory Affairs Executive with around 5 years of experience in regulatory submissions for international markets, especially USFDA and EDQM . This role involves end-to-end regulatory dossier preparation and submission, technical data coordination, and maintaining compliance with global regulatory standards in an API manufacturing environment. Key Responsibilities Prepare, compile, and submit regulatory dossiers (DMFs, CEPs, ASMFs) to international authorities, focusing on EDQM and USFDA. Coordinate cross-functionally with R&D, QA, QC, and Production teams for document and data collection. Maintain submission timelines and follow-up systems for timely ...

Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 02.08.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. ...