933 Usfda Jobs - Page 3

Perform surgical procedures related to the ear, nose, and throat. Conduct thorough examinations and diagnoses to determine the best course of treatment. Required Candidate profile MS degree in a relevant field. Strong knowledge of ENT surgery procedures and techniques. Excellent communication and interpersonal skills.

Role & responsibilities 1. DMF Complications 2. Query response preparations 3. life cycle management 4. Marketing/ Customer Communications 5. Quality Documents/ Submissions review 6. Change Control Management/ RIMS Management

Position: Analyst Quality Control LCMS (Liquid ChromatographyMass Spectrometry) Qualification: M.Sc. in Analytical Chemistry or related field Experience: 1 to 2 years Key Responsibilities: Perform LCMS analysis for routine, stability, and validation samples. Support method development and transfer activities. Maintain instrument calibration logs and documentation. Ensure cGMP, data integrity, and safety compliance. Work in shifts as per laboratory requirements. Skills Required: Hands-on experience in LCMS operation. Attention to detail and accuracy in documentation. Basic understanding of analytical method validation.

Position: Manager Quality Control -LCMS (Liquid ChromatographyMass Spectrometry) Qualification: M.Sc. in Analytical Chemistry or related field Experience: 10-15 years Key Responsibilities: Lead installation and qualification of LCMS instruments. Manage method development, validation, and transfer activities. Supervise routine and non-routine sample analysis using LCMS. Ensure data integrity, cGMP compliance, and documentation accuracy. Review analytical reports, protocols, and SOPs. Coordinate with QA, R&D, and Production for analytical support. Train and guide the team; manage activities across shifts. Participate in internal and external audits and ensure timely closure of observations. Sk...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Master of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes b...

Collect and review documents to ensure FGI has the appropriate documents required. Complete work permit and other immigration forms. Assist in the preparation of letters for case work. Collate cases for submission. Prepare submissions for client signature and upload to IRCC portal for adjudication. Update case management system throughout entire case lifecycle (milestones, emails, approvals, etc.). Communicate with client through balance of process for updates. Review and update client reports on a daily/weekly basis. Generate weekly client status and audit reports via case management system.

Job Responsibilities- Assisting in developing audit planning documentation addressing scope,auditobjective, budgeted hours, resource plan,and reporting date Complete assignedaudits, addressing allauditobjectives, conducting clientandstatus meetings as required, controlling, monitoring,and reporting onauditprogress, reviewing work papers,and ensuring work papers provide adequate support of conclusions while complying with internal standards for documentation. To monitor the assignment for improving the efficiency of the assignment, manageauditin relation to time and resource budget Will actively check that all findingsandissues are documentedandperform closedown procedures Gatheringandcompili...

To execute engineering projects related to facility upgrades, equipment installation, and compliance enhancements in alignment with cGMP and USFDA standards. Key Responsibilities Project Execution & Management: Assist in planning, scheduling, and executing engineering projects including new installations, modifications, and expansions. Coordinate with cross-functional teams (Production, QA, QC, EHS) for smooth execution. Ensure timely completion of projects within budget and quality parameters. Compliance & Documentation: Ensure all engineering activities comply with USFDA, cGMP, and other regulatory requirements. Prepare and maintain project documentation including URS, DQ, IQ, OQ, PQ, and ...

Roles and Responsibilities Perform breakdown maintenance, corrective maintenance, preventive maintenance, and sterile injectable equipment to ensure optimal performance. Ensure compliance with USFDA regulations during all manufacturing processes. Maintain accurate records of equipment calibration, cleaning validation, and batch production runs. Collaborate with cross-functional teams to resolve issues related to injectables manufacturing. Desired Candidate Profile 4-9 years of experience in pharmaceutical industry with expertise in breakdown maintenance, corrective/preventive maintenance, HPLC analysis, formulation development. B.Tech/B.E. degree in Electrical or equivalent qualification. St...

Responsibilities: Experience in Method Validation. Experience in Stability Study. Experience of review Electronic data review and backup systems. Expert in Qualification of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Expert in Calibration of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Must have minimum 3+ years of experience as a Reviewer. Must have an experience of reviewing all types of QC software. Must be familiar with cGMP/GLP practices and ICH and FDA Guidelines. Required Skills Must be excellent in written and spoken English; net savvy and adept at computer skills. Logical thinking. Organizing. Good in communication. Required Qualification: - B.Sc/M.Sc - Chem...

Responsibilities: Supervise daily manufacturing operations for sterile injectable products (vials, ampoules, lyophilized, or PFS). Ensure compliance with cGMP , GDP , and regulatory standards (USFDA, WHO, MHRA). Oversee aseptic operations like compounding, filtration, aseptic filling , and lyophilization . Lead and train production staff in cleanroom behavior and SOP adherence . Maintain accurate batch records , logbooks, and documentation. Handle deviations, CAPA, and support audits and regulatory inspections. Coordinate with QA, QC, and Engineering for smooth production flow. Ensure equipment readiness and proper cleaning/sterilization processes. Required Skills Experience with oncology in...

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations.Prepare and review regulatory documents, including applications and reports.Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services.Excellent communication and coordination skills.Ability to work effectively in a fast-paced environment.

Publish regulatory submissions to relevant authorities, ensuring compliance with required standards and regulations.Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Required Candidate profile Strong understanding of employment firms and recruitment services.Excellent publishing skills, with attention to detail and ability to meet deadlines.Ability to work independently

Interested Candidate please share your resume to atull@harmanfinochem.com Job description Below are details for QC candidate to be recruited. Must have 3 to 6 yrs of experience in QC Should handle HPLC / GC instrument. M.Sc or B.Sc with experience also preferred. Should have worked in GLP /GMP environment Must have experience in API QC Shall have knowledge of 21 CFR / CSV / data integrity / validations Shall have knowledge of Method validation / Method transfer

8 years experiences for RA role in medical device and or pharmaceutical industry.Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Required Candidate profile Desired Skills:RA role in medical device, US FDA and EU. Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors.

Procurement Operations: Source and procure raw materials (APIs, excipients), packaging materials, and other pharma-related items. Evaluate purchase requisitions and coordinate with internal departments (production, QA/QC, R&D) to ensure timely procurement. Issue purchase orders (POs) and track their status until delivery and GRN. Vendor Management: Identify, evaluate, and develop new suppliers and maintain strong supplier relationships. Negotiate prices, payment terms, delivery schedules, and contracts. Monitor vendor performance based on quality, cost, delivery, and service. Inventory & Cost Control: Coordinate with the inventory team to maintain optimum stock levels. Analyze and control pr...

ONLY EXPERIENCE CANDIDATE CAN APPLY Job description: - We are looking for a Regulatory Affairs Executive with strong knowledge of pharmaceutical products. The candidate must have experience in domestic regulatory compliance (FSSAI/CDSCO) and export documentation , specifically for LATAM & ROW. Responsibilities include dossier preparation, label review, and coordination with departments for regulatory submissions. Key Responsibilities: 1. Handle regulatory documentation and submissions for Pharmaceutical Products (domestic & export). 2. Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Etc.) and international regulations . 3. Ensure products comply w...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life ¢- enabling them to improve outcomes...

Handle customer inquiries and resolve issues professionally.Provide excellent customer service through various communication channels.Develop and maintain strong relationships with customers. Required Candidate profile Strong communication and interpersonal skills. Ability to work in a fast-paced environment and adapt to changing situations. Proficient in French, US/Canada shift, and other languages as required.

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...

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or healthcare industry. Strong understanding of regulatory requirements, including FDA, EMA, and ICH guidelines.

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Publish regulatory documents, such as reports and updates, on time and accurately. Required Candidate profile Strong knowledge of regulatory compliance principles and practices. Excellent writing and publishing skills, with attention to detail and accuracy.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or biotechnology industry. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or biotechnology industry. Strong understanding of regulatory requirements,