933 Usfda Jobs - Page 14

Roles and Responsibilities To be handle all API pharma equipment w.r.t. manufacturing. Perform operation related activities. Ensure compliance with regulatory requirements. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Maintain accurate records, reports, and documentation. Desired Candidate Profile having experience in API pharma industries. Strong understanding of Good Manufacturing Practices (GMP) regulations. Experience with Cleaning Validation & Equipment Qualification procedures.

Reviewing submission related documents including Inactive Ingredient Evaluation, Q1/Q2, Product Development Report, Quality Plan, Product Manual, Trade dress, Specifications, Master Packaging Card and Validation Protocols/Reports etc. DMF Review for ANDA submissions. Outlining requirements for labelling, storage and packaging for FDA submission. Compilation of ANDA sections of US market for sterile dosage form. Review of manufacturing related documents such as BMR, BPR and Stability study Protocols /Reports etc. To draft response and timely submission for regulatory deficiencies. To coordinate with cross-functional teams for regulatory requirements. Keeping up to date with regulatory guideli...

Biological E. Limited invites dynamic & self-motivated fresher candidates for Production & Quality Assurance department at its Pharma SGI - Injectables USFDA Approved plant, Shamirpet, Hyderabad: Desired Candidate Requirements: Good communication skills Able to work in shift operations (A,B & C) B.Pharmacy & M.Sc. passed in 2024 & 2025 with > 60% marks Learning apatite Confidence Prepared male candidates

Biological E. Limited invites dynamic & self-motivated fresher candidates for Production department at its Pharma SGI - Injectables USFDA Approved plant, Shamirpet, Hyderabad: Desired Candidate Requirements: Good communication skills Able to work in shift operations (A,B & C) B.Sc & Diploma passed in 2024 & 2025 with > 60% marks Learning apatite Confidence Prepared male candidates

Role & responsibilities Executive - Quality Assurance Preferred candidate profile Review of Equipment Qualification related documentation. Review of Computer System Validation related documentation. Exposure of Cleaning Validation. Exposure of Software like EDMS, LMS, Trackwise.

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...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...

Number of requirements 1 / Level 3 rd Experience: 6 to 7 Years Job Overview: As a SAP CRM Consultant specializing in Application Support Management, the primary responsibility will be to provide ongoing application support, maintenance, and request fulfillment enhancements for SAP CRM systems. The consultant would have to work closely with business users to understand their needs and ensure that the CRM application remains reliable, secure, and aligned with GB ( Business Unit) goals. Qualifications: Bachelor's degree in a relevant field, such as Computer Science, Information Technology, or Business. Proven experience in SAP CRM On Premise application support and management. ( 6-7 years) Stro...

Ensure GLP,GDP, STPs, SOPs & SOIs. Calibrate & maintain HPLC, Rheometer, Viscometer, balances. Perform analytical methods and Q3/PEQ characterization studies. Protocols,reports,reagents,routine analysis, PSD, rheology, viscosity, and related studies.

Planning and execution of production activities in Granulation, Compression, Coating & Capsule Filling area. Responsible for handling RMG, FBD, Coating, Compression & Capsule Filling Machine. Responsible for preparation and review of BMR & BPR. Ensuring daily cleaning activity & Machine preventive maintenance as per schedule. Handling of QMS activities like Change Control, Deviation & CAPA.

Responsibilities: Ensure compliance with regulatory requirements through CSV processes. Implement LIMS, Labware Lims & DMS systems. Conduct CSV activities for equipment validation. Health insurance Annual bonus Provident fund Flexi working

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide y...

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...

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...

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...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications

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 by...

Position Purpose Associate will be responsible for performing and covering daily exposures related to Collateral Management with multiple clients. Resource will work on the daily tasks, monitor the client portfolio, and will report directly to the Team Manager of the Collateral process. The staff will be working closely with Paris management, Relationship management, Front office, external counterparts as part of their daily BAU. Responsibilities Direct Responsibilities Collateral Manager is in charge of managing and ensuring that the collateral is sufficient to cover associated risks and that it is appropriately allocated and managed. Day to day production Get trained in respective function...

To ensure and carry out the analysis of stability sample and all other activities as per Standard Operating Procedure (SOP). To get involve and support in investigation of failure of any material or product in case of any out of specification (OOS) or Out of trend (OOT) or laboratory incident or non-conformity and take corrective and preventive actions. To raise and implement change control or document change request wherever necessary. To follow and ensure Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) inside Stability lab. To ensure availability of the working & impurities standards as per various pharmacopoeia. To assist Supervis...

Note to Hiring Manager: In support of BNP Paribas APAC's Diversity Commitment, Hiring Managers are to consider at least 1 Asia Pacific national, 1 male and 1 female candidate for the position to be filled. Position Purpose Facilitating transaction processing of instructions received from Client to ensure all settlement of trades in Global markets. Providing round the clock service to cover client queries across ASIA, EMEA and US regions. Reconciling client positions to match with the market positions. Being a team player and a manager to achieve team co-ordination, adhere to BNP policies and follow the agreed timelines to avoid any breach in SLA. Responsibilities Job summary Roles & Responsi...

Post - API Pharma Production Engineer Location - SUPA Ahmed Nagar Experience - 02-04 yrs Email - punemechanical@gmail.com Contact - 9356395439 Skills - API , Pharma Production , PPC Education - BSC / MSC Chemistry / Bio technology

Multiple requirements as Analyst for HPLC, GC and ICP at middle and senior level. Experience from public testing lab will be an added advantage. Preference will be given to immediate joiners or who are ready to join in short notice period. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

Job Title: AQA Quality Assurance (LCMS, GCMS, ICPMS) Company: Energon Labs Location: Hyderabad Experience Required: 2 - 6 years Employment Type: Full Time, Permanent Role Overview We are seeking experienced professionals in Analytical Quality Assurance (AQA) to review and ensure compliance in analytical data generated through LCMS, GCMS, and ICPMS techniques. The role requires a keen eye for detail, strong knowledge of analytical methods, and the ability to uphold the highest quality standards. Key Responsibilities Review analytical data for LCMS, GCMS, and ICPMS techniques. Conduct electronic audit trail reviews for analytical instruments and ensure compliance. Review Analytical Method Vali...

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) Walk-in interview 22-Sept to 26-Sept 9.30am to 5pm on 27-Sept-25(Saturday) from 9.30am to 3pm

Role Overview: You will be responsible for leading end-to-end execution of greenfield/brownfield injectable facility projects. This includes covering design, budgeting, procurement, construction, commissioning, and qualification. Your main focus will be on ensuring uninterrupted and compliant operation of critical utilities such as WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems. Key Responsibilities: - Ensure all systems and documentation meet cGMP, GEP, and regulatory standards like USFDA, EU-GMP, WHO-GMP. - Prepare for and support audits and inspections, collaborating with QA, Production, Validation, and EHS teams. - Manage third-party vendors, consultants...