933 Usfda Jobs - Page 13

Candidate should technically sound for assigned profile- Candiadte should have regulatory exposure in previous organisation

Role Description The Staff Accountant will be responsible for processing bank receipts and payments, and performing bank reconciliations. The role requires working effectively under tight deadlines, attention to detail, and high-quality analyses. The position reports to the Senior Accountant. Role and responsibilities Bank accounting receipts and payments (US/EMEA/APAC) Managing and creating bank payment runs Performing daily bank reconciliations Keeping track of all bank charges and interest cost Managing Month End Close for treasuring and banking, and related tasks like Bank module close, bank reconciliation, interest cost accruals, forex revaluation, etc. Formulate Standard Operating Proc...

You will be responsible for testing finished products and analyzing them using instruments such as HPLC, GC, and Dissolution apparatus. Your key responsibilities will include: - Conducting finished product analysis - Performing injectables analysis, focusing on physical parameters using HPLC and GC - Operating instruments like HPLC, GC, Auto titrator, IR, and troubleshooting HPLC/GC issues - Participating in audits by regulatory bodies like USFDA, MHRA, TGA It is essential that you possess good communication and documentation skills, as well as an understanding of data integrity concepts.,

1) Understand and develop immediate release and modified release oral formulations for regulated markets (US and EU market); 2) Handling equipment’s for solid oral dosage forms. 3) Troubleshoot in existing products and optimize the process; Required Candidate profile 4) Knowledge of using Design Expert/Mini Tab QbD Software for development conduct experiments. 5) Preparing reports like PDR, specifications, stability protocols, DoE, Tech transfer & Reports.

Handle pharma systems including LIMS, CSV-validated applications. Ensure compliance with GMP/GxP regulations, 21 CFR part 11 and assist in periodic validation & audits. Provide first-line support for IT systems & infrastructure. Support QA, QC & IT. Required Candidate profile Pharma (USFDA) experience is mandatory. Maintain backup, disaster recovery & cybersecurity protocols, backup. Implement new IT projects & digital transformation initiatives. Document IT incidents.

Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team i...

Job Title: Sr. Executive/Executive Department: DQA Job Summary, Duties/Responsibilities: Ensure proper guidance on quality issues to the Product Development Teams Review the documents received from R&D, AR&D, etc. so that the same can be shared with authorities and customers . coordination communication and to respond customer complaint/query and regulatory authority. Review the process change proposals and help the team members provide guidance on change proposals Review the in-house expert reports/Quality overall summary (QOS) prepared by the team members Ensure proper stage gate compliance at various stages of product development Ensure that internal audits are conducted properly Review t...

Location: Ahmedabad Qualification: M.Sc./Ph.D. (Organic Chemistry) Experience: 0-6 months Job Description: Assist senior scientists in carrying out experiments related to API, CRO, and CDMO projects. Perform basic laboratory activities such as reaction setup, sample preparation, and documentation. Support in maintaining lab safety standards, equipment handling, and record keeping. Learn and apply analytical techniques under guidance. Skills Required: Strong academic knowledge of Organic Chemistry. Willingness to learn API process research and development. Good communication and documentation skills. --- 2. Executive / Sr. Executive R&D (API/CRO/CDMO) Location: Ahmedabad Qualification: M.Sc./...

Role & responsibilities Strategic Leadership: Provide overall direction, leadership and vision for the Dahej Plant. Drive operational excellence and continuous improvement initiatives. Ensure adherence to corporate goals, compliance, and sustainability objectives. Regulatory & Compliance: Ensure strict compliance with USFDA and other international regulatoryguidelines. Lead and support inspections, audits, and regulatory submissions. Establish and maintain robust quality systems and EHS practices. Operations Management: Oversee end-to-end plant operations including Production, Quality, Engineering, Maintenance, Supply Chain, HR, IT, and Administration. Drive productivity, efficiency, and cos...

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...

Oversee the formulation, blending, and packaging processes in compliance with GMP and industry regulations Ensure adherence to quality control standards, safety norms, and environmental regulations Optimize resource utilization Required Candidate profile Coordinate with R&D, QA/QC, and supply chain teams for smooth product flow. Liaise with management on production planning, reporting, and audits. Maintain documentation as per regulatory guidelines.

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

Cost of Poor Quality and waste reduction: Develop evaluation metrics and tracking cost of poor quality and take proactive measures to reduce wastages and product recalls. Analytical cost: Control analytical cost against the budget. Analyze and approve waste with Cost as a Parameter Customer Service Customer Interactions: Interactions with customers to meet the various Quality, Food Safety, Regulatory & Compliance requirements which customer seeks from time to time. Monitor the customer complaints and prepare details root cause analysis and mitigation plan. Product Quality Index /Customer satisfaction index: Monitor and improve product quality index and customer satisfaction index by enhancin...

Recorders and Medicare Systems Pvt Ltd is looking for RA Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available ...

Oversee the formulation, blending, and packaging processes in compliance with GMP and industry regulations Ensure adherence to quality control standards, safety norms, and environmental regulations Optimize resource utilization Required Candidate profile Coordinate with R&D, QA/QC, and supply chain teams for smooth product flow. Liaise with management on production planning, reporting, and audits. Maintain documentation as per regulatory guidelines.

What youll do: Manage the end-to-end Medical, Legal, and Regulatory (MLR) review process for promotional and non-promotional content submissions. Prepare and submit materials into review platforms (e.g., Veeva PromoMats ), ensuring metadata accuracy, reference linking, and version tracking. Coordinate with content creators, brand teams, legal, and medical reviewers to schedule review meetings and ensure timely feedback. Track review outcomes, manage revisions and resubmissions, and escalate bottlenecks or delays as needed. Ensure compliance with internal SOPs, regulatory guidelines (e.g., FDA, EFPIA, ABPI), and therapeutic-specific mandates. Maintain and update MLR trackers, dashboards, and ...

Skills Required: Graduate / PG in management With a minimum of 4-7 years of experience in managing the Admin function. Must have hands on experience into Advance Excel Key Responsibilities Making MIS Reports of collated data Meticulously working on the data collated from various sources of department and preparing comprehensive reports Ensuring the precision of the reports Preparing Delivery Files Extensive work on Excel Preparing necessary dashboards for day to day operations Monitor & analyses data for business trends & prepare monthly revenue & collection report Provide cross functional quality oversight from a compliance perspective fo testing and disposition, quality investigations, val...

Key Skills :QMS, GMP, GDP, Audit & Compliance, SOP Management ,equipment qualification IQ/OQ/PQ,ICH, WHO, USFDA Qualifications: B.Pharm / M.Pharm / M.Sc. in Chemistry, Microbiology Experience : 7–10 pharmaceutical manufacturing setup. CTC : 6-9 LPA

Questions before applyingPlease contact PVYN@nne Please note we only accept applications submitted through our online recruitment system You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV To ensure an efficient and fair recruitment process, we encourage you to refrain from adding a photo in your CV At NNE, we commit to an inclusive recruitment process and equality of opportunity for all our job applicants We will invite to interviews on a running basis To learn more about us visit nne

Exciting Career Opportunities at Natco Pharma Limited for the following requirements Open Positions: Operators & Supervisors OSD Production & Packing (Onco & Non-Onco) Experience: 0 to 6 Years (Freshers graduated in 2024/25 are eligible) Qualifications: I.T.I / Diploma / B. Pharmacy / M. Pharmacy Key Responsibilities: Operate equipment's in Granulation (RMG, FBD, ACG, GEA), Compression (GEA, Sejong), Coating (NEOCOTA), Capsule Filling (Bosch, MG02), Blister Packing (CAM NMX, HV1, BQS, IMA/ACG), and Bottle Packing (CVC, Optel) lines. Supervise production lines, including Granulation, Compression, Coating, and Packing (Blister/Bottle). Good verbal and written English communication skills 2. Tr...

Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

We are looking for a highly skilled and experienced Regulatory Compliance Publisher to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry. The ideal candidate will have 2-4 years of experience. Roles and Responsibility Develop and implement regulatory compliance programs to ensure adherence to industry standards. Conduct risk assessments and audits to identify areas for improvement. Collaborate with cross-functional teams to ensure seamless execution of regulatory requirements. Publish regulatory documents and reports as required by relevant authorities. Stay updated on changes in regulations and laws affecting the organization. P...

We are looking for a highly skilled and experienced Regulatory Document Publisher to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry. The ideal candidate will have 3-8 years of experience in regulatory document publishing. Roles and Responsibility Publish and maintain regulatory documents, ensuring accuracy and compliance with relevant laws and regulations. Collaborate with cross-functional teams to ensure timely submission of regulatory documents. Develop and implement processes to improve regulatory document quality and efficiency. Conduct thorough reviews of regulatory documents to identify areas for improvement. Stay update...

Job Description: We are seeking a highly skilled and experienced professional for the role of Formulation Development OSD , focused on regulated markets including USFDA, MHRA, EMA, and other global regulatory agencies. The ideal candidate will have a proven track record in developing and optimizing solid oral dosage forms (tablets, capsules) for submission and commercial-scale manufacturing. Key Responsibilities: Lead and execute formulation development projects for oral solid dosage (OSD) forms targeted at regulated markets (US, EU, etc.). Design and execute pre-formulation and formulation trials, optimization, and scale-up. Develop robust formulations and manufacturing processes based on Q...

Roles and Responsibility Develop high-quality regulatory documents, including clinical trial applications, marketing authorizations, and periodic safety update reports. Collaborate with cross-functional teams, including regulatory, clinical, and product development, to ensure compliance with regulatory requirements. Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and adherence to company standards. Stay up-to-date with changing regulatory requirements and industry trends to improve document quality and compliance. Provide training and guidance to junior writers on regulatory affairs and medical writing best practices. Participate in the development of new r...