933 Usfda Jobs - Page 27

Job Description Overall Single Point of Contact for Quality IT Projects (such as LIMS, Chromatography, QAMS, EDMS, LMS etc.) Finalization of URS in alignment with sites (India + Global). Harmonization of system and processes in line with regulatory requirements and compliances. Testing and Validation of IT applications in line with URS for QA/ QC/ Common applications. Keeping organization up to date on the requirement for smart QA/ QC. Defining SOP and training of personnel. Supporting operational team. Keeping senior management updated on the organization status. Keeping senior management updated on the organization status. Facing Regulatory Audits at site as and when required. Keeping site...

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Position: Production Executive / Officer Injectables Location: Ankleshwar,Gujarat Experience: 2-4 years Key Responsibilities: Carry out production activities as per SOPs and schedule Ensure adherence to cGMP and regulatory guidelines Maintain accurate production documentation (BMRs, logbooks) Coordinate with QA/QC for line clearance and sampling Support equipment cleaning, operation, and minor troubleshooting Follow all safety and hygiene protocols Requirements: B.Pharm/M.Pharm/B.sc/ Msc or equivalent 2- 4years experience in parental production Good knowledge of GMP and pharma documentation Strong attention to detail and communication skills

Write and/or edit high-quality scientific response documents independently under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Research and authors response documents, reviews compendia, and prepares US FDA Annual reports with minimal guidance, acting as an SME on different types of response documents and other GMI activities. Proficient understanding of Medical Information achieved through a combination of product knowledge, along with editing, writing, and document management. Essential Job duties and responsibilities: 1 ) Proficient in Conducting literature searches and reviews; and extracting/ summarizing complex...

Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like - US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. Maintain life-cycle / post approval changes for drug product registration dossiers. Provide regulatory support to cross functional departments. Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway Review, preparation and submission of annual reports to US FDA Review, prepar...

Dear Candidate, Greetings of the day! We are hiring for the position of Cluster Head IT (GM) for Aurangabad location. Company Profile: Harman Finochem Limited leading India-based pharmaceutical company which was established by Late Mr. Bhupinder Singh Manhas in 1983. It specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APIs) of which 10 are Essential drugs as per the WHO model list. Company has its Head office at Kalina, Santacruz (East), Mumbai and 3 state-of-the-art API manufacturing facilities and one formulation manufacturing site at Aurangabad that have been inspected by USFDA. Role & responsibilities : Establishing organizational technology vi...

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...

Greetings!!!! We are seeking a dynamic and experienced Site Head to lead a CRAMS pharmaceutical manufacturing site . The role demands strategic leadership, cross-functional coordination, regulatory compliance, and operational excellence. Key Responsibilities: Oversee day-to-day site operations (production, QA/QC, engineering, supply chain) Ensure GMP compliance and regulatory readiness (USFDA, WHO, EU GMP) Lead cross-functional teams and drive business KPIs Client management for CRAMS / CDMO projects Lead tech transfer, scale-up, and capacity expansion projects 1. Site Operations Leadership Oversee day-to-day operations of the site (R&D, API/Formulation manufacturing, QC/QA, Engineering, EHS...

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

The ideal candidate should have strong knowledge of sportswear products and demonstrate His passion to achieve maintain the quality of products as per brand standards. Job Responsibilities Ensure raw materials and finished products meet specifications through meticulous examination and precise measurement tools. Perform durability, functionality, and safety tests to validate product quality and performance using standardized methods. Maintain detailed records of inspections, noting deviations or defects found to ensure traceability and quality control. Communicate identified defects promptly to supervisors and collaborate on corrective actions for timely resolution. Verify products meet indu...

Role & responsibilities: Preferred candidate profile :

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion ...

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, an...

: Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate 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...

: Job TitleBond Analytics Analyst, AVP LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader inCash Managemnet, Trade Finance & Lending, Securities services and Trust & Agency Service. Focusing on the treasurers and finance departments ofcorporate and commercial clients and financial institutionsacross 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 Deutsche Bank has long...

Job description Role & responsibilities HPLC Analysis of Solid Orals/Nasal hands on experience on QC activities, RM, Packing, In Process and Finished Products Compliance with GMP/GLP Practices Preferred candidate profile

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Bilaspur. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of t...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1 to 6 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Sup...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Hubli. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervis...

We are looking for a highly motivated and customer-focused individual with 0 to 3 years of experience to join our team as a Customer Service Executive in Coimbatore. The ideal candidate will have excellent communication skills and the ability to work effectively in a fast-paced environment. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager, including identifying potential business customers. Collect and validate customer documents according to organizational norms. Log cases in the system following SOPs and processes for disbursement. Fulfill sanction ratios as per organizational requirements. Meet customer needs and cross-sell multiple products with the hel...

We are looking for a highly skilled and experienced Deputy Head to lead our Small and Medium Business-Internal Audit team in Mumbai. The ideal candidate will have 10+ years of experience in internal audit, preferably in the banking or financial services industry. Roles and Responsibility Develop and implement effective internal audit plans to ensure compliance with regulatory requirements. Conduct risk assessments and audits to identify areas of improvement in business operations. Collaborate with cross-functional teams to design and implement process improvements. Provide expert guidance on internal controls, auditing standards, and regulatory requirements. Identify and mitigate risks assoc...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Guwahati. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Super...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Superv...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Nagpur. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the...