933 Usfda Jobs - Page 9

Job Summary: Responsible for leading all Quality Control (QC) activities for sterile injectable products. This includes ensuring cGMP compliance, timely testing of materials and products, method validations, and lab readiness for audits and inspections. Key Responsibilities: Oversee day-to-day QC lab operations for sterile injectables (raw materials, in-process, finished product, and stability samples). Ensure compliance with cGMP, regulatory guidelines (USFDA, MHRA, EMA), and internal quality standards. Review and approve SOPs, methods (STP, GTP), specifications, protocols, and validation/transfer documents. Manage method validation, verification, and transfers for drug substances, products...

Job Title: Deputy Manager- Formulation Location: Govandi, Mumbai Department: Corporate Quality Assurance Qualification, Experience and Technical Competency: 1. Master’s Degree in Pharmacy or Science or equivalent scientific field. 2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of Formulation industry with 2 to 3 years experience in Quality Control.) 3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP) 4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management Systems (QMS) and regulatory guidelines. Key Requirements: Responsible for Quality Functions across Own Sites and Contract Sites with adherance to cGMP, Regulatory standards and...

Senior Manager 1

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Description Regulatory Manager (CMC, EU Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

We are hiring for Plant Maintenance/ Process Maintenance Engineer at Amneal Pharmaceuticals Ahmedabad. Only for Pharma experience candidates : Job description: We are looking for passionate and skilled professionals to join our Engineering Injectable plant maintenance Department. (Instrumentation / Electrical / Mechanical). Position: Officer / Executive Qualification: Diploma / B.Tech. (Instrumentation / Electrical / /Mechanical) Experience : 4 to 9 Years Location: Amneal, SEZ Matoda, Ahmedabad What We are Looking For : Hands-on experience in Preventive & Breakdown Maintenance of injectable manufacturing lines such as : Vial Line, Microfiber line, PFS Line & Ophthalmic Line. Schedule mainten...

Role & responsibilities Complete Analysis of various raw materials, In-process, Drug substance and finished Products in line with Pharmacopeia method and in-house Specification and test procedures. Change Control, Deviation, Root Cause investigation, CAPA, OOS, OOT, Incidence Calibration of Instruments HPLC , UV-Visible Spectrophotometer, pH Meter,KF Titrator, weight balance. Working standard preparation as per SOP. Ensure the timely analysis of samples GLP, GMP, GDocP (With respect to Regulatory Guidelines) Function in details of various Section of QC/QA(Eg.Raw Material, Finished Product,Stability Study etc. Data Integrity 21 CFR Part 11 Qualification, Calibration, Validation. Maintaining t...

Title: Chief Purchase & Supply Chain Officer (CPSCO) Location: Ahmedabad, Gujarat Experience: > 15 years Education: Bachelor's or Master's in Chemical Engineering, Pharmacy, Pharmaceutical Technology, or Chemistry, preferably from the pharmaceutical industry, An MBA in Supply Chain Management, Operations, or a related field will be an added advantage About LOXIM Founded in 1977, LOXIM has been at the forefront of combining chemistry with strategic business expertise to deliver high-quality solutions for global markets. Our portfolio spans APIs, Intermediates, KSM, and CMO/CDMO capabilities within the pharmaceutical industry, Dyes and Engineering Plastics. Headquartered in India , we operate ...

,in-processthe ,for leading,for leading,problem-solvingResponsibilities We are looking for a senior professional AGM with a range of 15 to 20 years of experience in Analytical Method Validation for regulated markets. The role involves leading API and excipient method validation across multiple dosage forms and managing a team of 30, including three senior managers. The ideal candidate must be technically strong, experienced in US/EU compliance, and hold an M. Pharm, M.Sc., or Ph.D. Role & responsibilities: Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Responsible for RM & PM characterization and documentation. Generate qualificat...

Over all QA activities to produce Quality products . Having major audit exposures like EU, USFDA , MHRA , WHO, TGA, ANVISA , PIC etc audits compliance and cGmp requirements.. Education B Pharm/ M Pharm Candidates with experience 3 - 7 years in reputed Pharma company.

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years 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 do Embedding digital transformation in healthcare operati...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years 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 do Embedding digital transformation in healthcare operati...

Job Title: ESO QA Specialist Location: Ankleshwar, Gujarat, India Seeking experienced QA professionals with 5+ years in GMP environments. Responsible for quality lifecycle management, audits, CAPAs, change control, and regulatory compliance.

Quality Control Leadership Raw Material to Finished Product Quality Documentation & Regulatory Compliance Audit & Inspection Readiness Laboratory Operations Product Lifecycle & Continuous Improvement Customer Interface & Regulatory Documentation

Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production departments. Help maintain regulatory databases, tracking sheets , and product registration status logs. Learn and follow current regulatory guidelines (USFDA, WHO, MHRA, EU, CDSCO) . Assist in the submission of post-approval changes , annual updates, and renewal applications. Draft and format regulatory documents, letters, and summaries . Help respond to regulatory agency queries and deficiencies under guidance. Ensure compliance with documentation practice...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

Roles and Responsibilities (5 days working) Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets. Handle team responsibilities related to dossier compilation, review, and approval. Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization. Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines. Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation. Desired Candidate Profile M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs. Strong understanding...

Responsibilities: Lead formulation development for OSD, external preparations, oral liquids, and injectables. Oversee pre-formulation studies, prototype development, and scale - up activities. Ensure compliance with regulatory guidelines (ICH, WHO, USFDA, etc.). Collaborate with cross-functional teams (QA, QC, RA, Production) for tech transfer. Mentor junior scientists and manage project timelines and documentation. Required skills: Strong knowledge of formulation science and process optimization. Experience in QbD, DoE, and stability studies. Excellent leadership and communication skills. Required Qualification: - B.Pharm/M.Pharm

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? Written and verbal communicationDetail orientationCritical ThinkingProblem Management" Excellent communication skills, Uses profession...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? Written and verbal communicationDetail orientationCritical ThinkingProblem Management" Excellent communication skills, Uses profession...

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? Written and verbal communicationDetail orientationCritical ThinkingProblem Management" Excellent communication skills, Uses profession...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...