196 Regulatory Audits Jobs - Page 2

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 ...

Role Overview: As the Key & Operational Lead for upstream fermentation operations, your role will involve overseeing end-to-end upstream fermentation operations, including media preparation, seed culture development, fermentation scale-up, and harvest. You will be optimizing classical microbial fermentation processes for high cell density and metabolite production using various microorganisms such as bacteria, yeast, or fungi (e.g., E. coli, Bacillus, Saccharomyces, Streptomyces). It will be your responsibility to ensure consistent achievement of production targets in terms of volume, yield, quality, and timelines. Additionally, you will troubleshoot upstream process deviations, contaminatio...

You are the Regional Security Manager (RSM) responsible for delivering effective and efficient physical security operations and programs to protect critical infrastructure for a complex, multi $100M global client account. You will manage a team of Campus Security Managers (CSMs) and Security Team Managers (STMs) in geographically separated facilities, ensuring compliance with security procedures and policies, tracking audit readiness, and providing direction to meet or exceed physical security requirements. Reporting to the Regional Director of Security Operations, you will work directly with management, the client, and other vendors to ensure accurate and timely service delivery. - Recruit,...

Gaining an understanding of the client's needs and requirements and communicating them and the quality standards to the production teams. Devising ways to improve the manufacturing process to ensure higher-quality goods. Required Candidate profile Strong attention to detail, observation, organizational, and leadership skills. Knowledge of quality control procedures and legal standards. Good technical and IT skills. Perks and benefits Bonuses Flexible Work Arrangements Paid Time Off

As an In-House Legal Counsel at our company, you will play a critical role in leading corporate legal, compliance, and financial partnership functions. Your responsibilities will include: - Overseeing entity setup, inter-company structuring (Transfer Pricing), and regulatory compliance across jurisdictions. - Structuring and overseeing financial partnerships to ensure alignment with commercial and regulatory requirements. - Ensuring adherence to data security laws (GDPR, SOC2) and global compliance frameworks such as KYC/KYB, business licensing, etc. - Providing legal support for fundraising activities (equity & debt), FinTech business models, and regulatory approvals. To excel in this role,...

Job description Execution of IT audits assigned in line with Internal Audit Annual Plan. Conduct regulatory audits for various banking applications including critical applications such as Core Banking System, Internet Banking etc. Examine internal IT controls, evaluate the design and operational effectiveness. Test and identify network and system vulnerabilities. Review, evaluate and test application controls. Prepare and submit audit report to stakeholders and Audit Committee Provide recommendations and guidance on identified security and control risks. Determine risk exposure, if any and develop remediation strategies. Ensure for closure of observations reported during IS/IT audits. Coordi...

Oversee Quality Control for API manufacturing, ensuring GLP, GMP, and regulatory compliance. Lead QC team, manage validations, audits, stability studies, and documentation from raw material to finished product with focus on quality excellence.

Job Requirements Role/ Job Title: Senior Specialist-IT Governance & Compliance (IT Compliance & Risk Specialist) Function/ Department: Information Technology Job Purpose The role entails the responsibility to be a part of IT Governance and Compliance Team of the bank and would be working towards GRC control function: Compliance & Regulatory reporting viz Cyber KRI, TRANCHE, ICAAP etc. Roles & Responsibilities Custodian of IT governance and IT process governance framework. Handling of Regulatory audits and submissions. To understand Indents from regulators, collated, review the data and timely submission. Responsible for IT policy creation, review, update, awareness, and monitoring. Administr...

As a Plant Engineer, you will be responsible for overseeing plant engineering activities related to both process and utilities. Your primary focus will be to ensure that the plant always remains cGMP compliant in terms of engineering aspects and safety standards. You should have hands-on experience in operational excellence to streamline plant operations efficiently. Key Responsibilities: - Manage a team of 80 people to effectively carry out engineering tasks - Preferably have experience in facing regulatory audits from USFDA and EU - Worked in injectable manufacturing sites to understand the specific requirements and challenges in this sector Qualifications Required: - Bachelor's degree in ...

As a Risk Analyst in the Regulatory and Customer Assurance team at Mastercard in India, your role involves contributing to the Technology Risk Management organization's mission of exceeding stakeholder expectations by managing technology risks effectively and ensuring a secure operational environment. **Key Responsibilities:** - Assist in preparing and maintaining a consolidated control framework. - Support the creation of a centralized inventory of security and technology risk management requirements. - Aid business owners in analyzing business and functional requirements arising from regulations and customer contracts. - Identify technology and security risk controls based on the analysis....

Roles and Responsibilities Conduct quality control analysis using HPLC, GC, UV, spectrophotometer, sterile techniques, and other relevant methods. Ensure compliance with USFDA, GMP, GLP regulations during regulatory audits. Develop and maintain SOPs for laboratory operations and testing procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Perform stability studies on APIs and finished products as required. Desired Candidate Profile 2-7 years of experience in a pharmaceutical industry setting with expertise in QC analysis. MS/M.Sc(Science) degree in Chemistry or related field; Strong understanding of analytical instruments such as HPLC, GC, UV s...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Use Your Power for Purpose Our manufacturing logistics and supply team ensures that customers and patients receive the medicines they need precisely when they need them. By embracing challenges, imagining what's possible, and taking decisive action, you will help accelerate the delivery of medicines to the world. Your role is crucial in making sure that the supply chain operates seamlessly, overcoming obstacles, and continuously innovating to meet the demands of healthcare. This dynamic environment requires a proactive approach, a visionary mindset, and a commitment to excellence, ensuring that life-saving treatments are always within reach for those who need them most. What You Will Achieve...

Review of Compliances and internal control applicable to Capital & Commodity intermediaries, Providing advisory to Broking and Financial Services company. Required Candidate profile CA/MBA/CFA with 3 or more year exp., Candidate should have practical exposure with Broking Company. Knowledge of business ops, software will be an added advantage.

Title: Parenteral Line Manager Job Grade: G9 Senior 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 coordination, new produ...

Job Description GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 46 years Role Overview We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . The specialist will lead Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, manage compliance documentation, and provide expertise in pharma quality systems. This role will play a key part in enabling compliant deployment of advanced digital solutions. Key Responsibilities Lead ...

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 Site Quality Head at our reputed pharmaceutical manufacturing company in Vapi, Gujarat, you will be responsible for leading and overseeing the Quality Assurance and Quality Control functions at our Oral Solid Dosage (OSD) facility. Your role will involve full ownership of quality systems, lab operations, regulatory compliance, and audit readiness. To excel in this position, you should currently hold a site-level quality head role and have hands-on experience managing QA and QC teams in a regulated pharmaceutical environment. **Key Responsibilities:** - Lead and manage the complete Quality function (QA and QC) at the site - Ensure compliance with GMP, regulatory, and customer requirement...

As the Head of Engineering & Maintenance at Piramal Pharma Solutions, you will play a crucial role in leading all engineering and maintenance operations for a large-scale API pharmaceutical plant located in Digwal. Your responsibilities will include ensuring optimal performance, reliability, and compliance of plant equipment, systems, and facilities. Your extensive experience in API manufacturing, expertise in CGMP, FDA regulations, and managing regulatory audits will be essential in this role. **Key Responsibilities:** - Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. - Develop and execute a comprehensive maintenance strategy, ensuring a p...

As a Food Safety and Quality Manager in the bakery and pastry production industry, your role is crucial in ensuring the highest standards of food safety, hygiene, and product quality are maintained. Your responsibilities will include: - **Food Safety System Development** - Overseeing and enhancing food safety management systems in the kitchen. - Implementing and upholding HACCP plans, managing critical control points, and making improvements as required. - Ensuring all food safety documentation and records are accurate and up-to-date. - Preparing the kitchen and team for regulatory audits such as FSSAI, FDA, ISO 22000, and BRC. - Conducting root cause analysis for any arising issues and impl...

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 States. It start...

We are looking for an experienced Quality Assurance Manager to lead and oversee QA activities at our API manufacturing facility.

Production Supervisor Pharma & Chemical Manufacturing (Hiring for a Leading Chemical/Pharma Manufacturer) Location: Vasai (1 Vacancy) & Tarapur – Boisar (2 Vacancies), Dist. Palghar, Maharashtra Experience: 2 – 8 Years Qualification: Diploma / B.E. in Chemical Engineering / Industrial Chemistry or related field Salary: As per Interview & Company Norms Gender Preference: Male Candidates Working Hours: Standard Shift Timings (No OT) 9 AM TO 6 PM Roles & Responsibilities: Plan, organize, and monitor daily production activities to achieve targets. Ensure compliance with SOPs, GMP, ISO, and statutory regulations . Supervise operators, technicians, and contract workers on the shop floor. Conduct s...

Role Overview: You will be responsible for developing, optimizing, and validating analytical methods using GC and GC-MS/MS for various sample matrices. Your role will involve performing routine and non-routine analysis of raw materials, intermediates, and finished products. You will interpret complex chromatographic data, ensuring accurate documentation and reporting. Additionally, you will maintain and calibrate GC and GC-MS/MS instruments to ensure compliance with regulatory standards. Troubleshooting instrument and method-related issues to ensure uninterrupted lab operations will also be a part of your responsibilities. You will be preparing SOPs, method validation protocols, and reports ...

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 ...