15 Regulatory Inspection Jobs

Job Summary: Responsible for managing Quality Control activities to ensure product quality, safety, and compliance with regulatory standards. Key Responsibilities: Oversee analysis of raw materials, in-process samples, and finished products. Ensure adherence to cGMP, GLP, and regulatory requirements. Review analytical data, COAs, and stability reports. Handle OOS, deviations, change controls, and CAPA. Manage analytical instrument calibration and validation. Support audits and regulatory inspections. Ensure proper documentation and data integrity. Lead and mentor QC team members. Qualifications & Skills: B.Pharm/M.Pharm/MSc with relevant experience. 10-12 years in pharma QC. Strong knowledge...

As a candidate for the mentioned role, you should possess a strong understanding of GMP requirements, exposure to Regulatory Inspection, and knowledge of international GMP requirements. Your experience should include investigations related to complaints, product rejections, non-conformances, recalls, deviations, audits, and regulatory inspections. Additionally, you should have managed change management, quality risk management, and Corrective Action and Preventive Action System throughout the Product Lifecycle. Implementation and maintenance of an effective Quality Management System should also be part of your expertise. Key Responsibilities: - Establish a roadmap for the remediation activit...

Global Life Science Hub is searching for a Vice President of Operations in India with a deep Biologics Manufacturing background to provide executive leadership for a large-scale, fully integrated biologics manufacturing campus with up to 50,000L of drug substance and drug product capacity. This leader will own end-to-end site performance across manufacturing, engineering, facilities, automation, and capital expansion, supporting global clinical and commercial supply. This role will be the senior-most operations leader in India, responsible for site build-out, start-up, scale-up, and long-term operational excellence, aligned with global supply strategy. Responsibilities: Provide full executiv...

Ugent opening for SR.Manager -DGM/AGM/GM - Production in Vadodara Location. Dept. : Production Must have experiance in Semi Solid Product(ointment/Gel/cream/lotion/ oral liquid) & Faced regulatory Inspections. 15+ years exp.in pharmaceutical industry

JOB SUMMARY Oversees the conduct of audits and conducts audits. Oversees hosting of customer audits and inspections and hosts customer audits and regulatory inspections. Provides inspection readiness training to staff. Provides consultancy on quality-related matters. May manage a team of auditors. JOB RESPONSIBILITIES • Oversees the conduct of audits and conducts audits in accordance with QA SOPs and WIs • Responsible for generating own and reviewing others audit reports. • Prepares for and hosts or supports customer audits in accordance with QA SOPs and WIs. Coordinates responses to customer audits of investigator sites, and resolves issues with customers, where applicable. • Plans and prov...

Title: Executive- IT Custom Field 2: 2928 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: IT GMP Operation, Computer System Validation, IT-SOP, 21CFR, Regulatory inspection, User Management, Data Backup, data security IT Policies Job Segment: Inspector, Law, Legal, Quality

As a Quality Compliance Manager at Amgen, you will play a crucial role in providing proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy within the General Medicine Therapeutic Area. Your responsibilities will include: - Acting as a GCP Subject Matter Expert to provide independent and objective quality advice for clinical trial activities. - Ensuring quality oversight for all stages of products in clinical development. - Utilizing the Risk Assessment Categorization Tool (RACT) to identify, prioritize, and mitigate risks in trials. - Supporting the establishment of regional expertise to ensure compliance with local regulations....

Work Your Magic with us! Ready to explore, break barriers, and discover more We know you've got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. The IT Governance Expert role will report to the Head of IT Audit & Compliance Management, and is part of the company's Digital Enterprise Solutions (DES) Organization. Your Role Evaluate IT Audi...

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...

As a remote analytical support personnel at PPL sites, your role involves reviewing analytical data and preparing various documents such as specifications, test methods, and protocols. You will be responsible for uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will prepare and review stability protocols and reports, and conduct stability data trending and analysis. Key Responsibilities: - Review analytical data generated in the analytical lab (QC/AS) including Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data in accordance with cGMP...

Role Overview: As a candidate for the position, you should have a strong understanding of GMP requirements, exposure to Regulatory Inspection, and knowledge of international GMP requirements. Additionally, you should possess experience in investigations related to complaints, product rejections, non-conformances, recalls, deviations, audits, and regulatory inspections. It is essential that you have handled change management, quality risk management, and Corrective Action and Preventive Action System throughout the Product Lifecycle. Your work experience of 15 to 18 years will be valuable in this role. Key Responsibilities: - Establish a roadmap for the remediation activities - Assure timely ...

Main Responsibilities : Responsible for preparation of critical spares list for all installations as per manufacturer s recommendations and plan for the inventory where the maintenance is carried out with in -house teams; Implement and oversee the preventive and predictive maintenance programme to reduce the risk of sudden failures of critical equipment; Assist the Technical Lead to review the maintenance/service practices of M&E Contractors to deliver quality work practices in line with the manufacturer recommendations; Ensure the logbooks, checklists and PPM schedules for all MEP equipments are adhered and records maintained at DCHI site; Manage Downtime/ Breakdowns; Arrange for ad-hoc M&E...

You are looking for a Senior Manager/AVP position in Credit Compliance at a bank in Mumbai. With 3-9 years of experience, you will be responsible for various key tasks related to regulatory compliance within the credit department. Your role will involve reviewing credit proposals presented to the Credit Committee, ensuring regulatory consistency, and highlighting any discrepancies. You will also evaluate credit policies, processes, and notes to provide feedback and advice for comprehensive and compliant bank operations. In this position, you will support the bank's business and credit functions by offering guidance on credit and lending matters from a compliance perspective. This includes ad...

Main Responsibilities : Responsible for preparation of critical spares list for all installations as per manufacturer s recommendations and plan for the inventory where the maintenance is carried out with in -house teams; Implement and oversee the preventive and predictive maintenance programme to reduce the risk of sudden failures of critical equipment; Assist the Technical Lead to review the maintenance/service practices of M&E Contractors to deliver quality work practices in line with the manufacturer recommendations; Ensure the logbooks, checklists and PPM schedules for all MEP equipments are adhered and records maintained at DCHI site; Manage Downtime/ Breakdowns; Arrange for ad-hoc M&E...

Ensure contractor compliance with GMP and regulatory standards.Conduct audits and inspections of contractors, manufacturers, and suppliers.Review and approve Batch Records, SOPs, and quality documents. Required Candidate profile Manage deviations, CAPA, and ensure timely corrective actions. Liaise between contractors and internal teams for smooth operations.