20 Edqm Jobs

The role involves preparing and reviewing regulatory documents, ensuring compliance with national and international guidelines, and supporting product registration processes. Required Candidate profile Looking for a Regulatory Affairs Officer with 2-3 years of experience in the Pharma/API sector. Candidates should have strong MS Office skills and good communication abilities.

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master...

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

MDMD EDQ_Full-Time_Bangalore/Pune/Navi Mumbai/Noida/Hyderabad/Chennai Job Title: MDMD EDQ Location: Bangalore/Pune/Navi Mumbai/Noida/Hyderabad/Chennai Job Type: Full-Time Experience: 4-6 years Job Description: Experience in EDQ, Integration development preferred. Oracle SQL DB, PL/SQL a must. Knowledge on JDE, PDH, CDH, SQM are preferred. Understand data feed from feeder systems and design Interfaces for importing the data Good understanding of the API or Mass data loading features Work with offshore team resources to identify tasks for Application Software configuration and development. Manage offshore resources for tasks completion and status and provide guidance, monitor performance Gathe...

We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufa...

Position- Executive/Sr. Executive Dept.-Regulatory Affairs Key Responsibilities Act as the first point of support for Business Development Managers on product-related queries from India. Coordinate and organize audits of supplier production facilities to ensure compliance with international standards. Gain exposure to and support during international regulatory audits (USFDA, WHO, ANVISA, EDQM). Understand and translate client quality parameters for raw materials, ensuring supplier adherence. Monitor supplier manufacturing processes for compliance with national and global standards. Assist in preparing and managing documentation for specification setting, change controls, regulatory submissi...

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at ...

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Pr...

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 ...

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

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Qualification: MSc in Analytical / Organic Chemistry Pharmacy Life Science Role Summary: Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance. Key Responsibilities: Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities. Ensure timely updates, maintenance, and life cycle management of submissions. Monitor global regulatory changes and communicate to internal teams. Handle customer queries, letters of access, and technical...

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at ...

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Se...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

Hi, We have opening for the position of API regulatory affairs department for API Manufacturing industry. Role & responsibilities 1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries 2. Submission of DMF amendments and variation filings to implement the post approval changes 3. Evaluation of change controls and perform regulatory assessment based on submitted DMF 4. Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D and review of documents received for registration purpose. 5. To Maintain regulatory database by following best regulatory practices 6. To prepare action plan for De...

Candidate should have fair knowledge of API & Formulation Stores functions. RM/PM Receipt, Storage, Material Issuance, Dispatch etc. Experience of regulatory audits like - USFDS, EDQM, PMDA etc. QMS related documents & Compliance. Statutory requirements of MA-1, MA-2, RS-2, AC-2, DS-5 and monthly returns, Quarterly returns, Yearly returns etc. Inventory Planning and accountability, stock requirements, material movement, hazardous material handling, tanker unloading etc.