940 Usfda Jobs - Page 38

Responsible for mechanical & utility maintenance at API plant. Handles preventive/breakdown maintenance, ensures continuous utility supply, manages equipment upkeep, regulatory documentation, and has experience in successful USFDA audits.

We are looking a skilled and motivated Executive IT (GMP Operations) with 3 to 5 years of experience for our Manufacturing Unit (Karakhadi Plant) The candidate will handling IT systems within GMP-regulated environments and support QC and Manufacturing IT operations with a strong focus on compliance, data security, and system integration. Key Responsibilities: Oversee IT GMP operations for QC and Manufacturing systems. Manage user access , data security , domain controllers , and backups . Integrate manufacturing equipment with IT systems and ensure GxP system compliance. Administer QC and Manufacturing applications like Chromeleon, Empower , etc. Operate and support SCADA, HMI , and other ma...

Gayatri Human Resources Immacule Lifesciences (P) Ltd. (Address. Village Thanthewal, Ropar Road, Nalagarh, Distt. - Solan, (H.P)-174101) Mobile No :- +91-8278729004 We are seeking a detail-oriented and proactive Regulatory Affairs Officer/Executive with hands-on experience in Oral Solid Dosage (OSD) regulatory submissions for international markets including ROW, USFDA, and MHRA . The ideal candidate will be responsible for compiling, reviewing, and submitting high-quality regulatory dossiers and ensuring compliance with the regulatory requirements of various global health authorities. Key Responsibilities: Prepare, compile, review, and submit regulatory dossiers (CTD/eCTD formats) for OSD pr...

Job Title:- Assistant / Deputy Manager – Regulatory Affairs (US Market) We are hiring Regulatory Affairs professional for the US Market. The candidate will be responsible for preparing, reviewing, and submitting ANDA

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assuran...

Responsibilities: Responsible Accountable over all Operations. (Like Production, QA,QC,Engineering Maintenance Projects, Process, EHS Administration function) Responsible for Profit Loss of Sites from Operations Point of View. Responsible for handling End to end Operation. Responsible for External Audit Internal Audit.(USFDA,WHO,MHRA etc) Implementation of Quality Management System as per Company /Statutory Guideline. Manpower Planning for the Responsible departments actualizations. Making sure that products are produced on time and are of good quality. Perform analysis of manufacturing materials and determining optimum control levels. Develop and motivate the cost effective alternatives ad ...

Job Description 1 Knowledge of operation & maintenance of Utility equipments like Chiller, Air Compressor, DG set, Boiler, Water pretreatment plant, UPS & ETP. 2 Should have adequate knowledge of Electrical maintenance of HT & LT Electrical Panels, Breaker and Transformer. 3 Hands on experience of qualification/validation of equipments, SOP preparation, PM, calibration of equipments, 21-CFR compliances. Should have knowledge of regulatory guidelines related to Engineering i.e. Water system, HVAC & compressed air. 4 Work Experience in USFDA / MHRA approved plants is must. 5 SAP Knowledge, Auto cad, Exposure to online documentation like SAP PM, eLog Books, QAMS. Work Experience 8-15 Years Educ...

Role & responsibilities Minimum 15+ years of experience in the pharmaceutical industry, Preferably in Multi Product API / Intermediate / CDMO or Innovator Products. Strong understanding of USFDA, EU GMP, regulatory compliance, and quality control principles. Prior Experience on Collaboration and Communication with Innovator CDMO organisations. Hands on experience on Digital tools like LIMS, Track wise, SAP HANA, 21 CFR Software Validation etc. Strong customer focus and problem-solving abilities under time bounded efficiency projects. Key Responsibilities: Quality Management System (QMS): Maintain the QMS, ensuring it aligns with latest industry standards and regulatory requirements. GMP Comp...

Role: Chemist / Sr Chemist Department: Production Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equa...

Conduct analysis of pharmaceutical products using HPLC. Develop & validate analytical methods. Documentation & Reporting. Calibration & maintenance of analytical instruments. Participate in regulatory inspections and audits, Required Candidate profile Experience of Pharma companies is mandatory. Should be aware of QMS related to QC. It is on the rolls of Cotecna Life Sciences. Share resume on nilesh.kadam@geochem.net.in or call on 9870476784.

Job Role: Junior Associate to Senior Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/BSc/B.Pharma/MSc/M.Pharma Years of Experience: 2 to 10 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with othe...

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...

Compile, prepare, critically review and submit the US ANDAs for Inhalation dosage form, Sterile dosage form and Nasal Spray with highquality, following the regulatory guidelines and internal processes within time lines. Ensure timely submission of all assigned projects. Ensure final US ANDA meets the requirement of latest ANDA checklist recommended by USFDA to avoid any acceptance to file issue. Prepare regulatory strategies for all assigned projects covering all key points. Work very closely with US regulatory Project mangers at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely sub...

Key Responsibilities: Talent Acquisition professional with strong experience in recruiting for USFDA-regulated Injectable Manufacturing plant-based roles. The ideal candidate should have expertise in bulk hiring, conducting walk-in recruitment drives, and maintaining a strong network within the pharmaceutical industry. Proficiency in sourcing relevant candidates through job portals like Naukri.com, LinkedIn Recruiter, and other platforms is essential. Maintaining MIS / Trackers related to Manpower (RAG, Employee Master, Offer tracker, etc.) Will support in employee engagement and other HR activities.

Qualification: Post-graduate in Pharmacy or Pharmaceutical Engineering Experience: 15 to 20 years in sterile manufacturing plant operations, with a minimum of 10 years in a leadership role and at least 7 years in a regulated sterile manufacturing environment. About The Company Fresenius Kabi Oncology Limited, a wholly owned subsidiary of Fresenius Kabi, is a leading player in the oncology generics market with a broad portfolio that includes injectables, cytotoxic, and APIs. Its state-of-the-art production facility in Baddi features dedicated units for cytotoxic and non-cytotoxic products, including liquid and lyophilized injectables. The facility is approved by global regulatory authorities ...