933 Usfda Jobs - Page 20

Key skills required by this role includes: Understand Regulatory operations Gather, review and analyse data regarding the business and its operations; prepare models and process maps for improvements; and communicate findings and suggestions to key stakeholders Understanding software requirements, ability to translate business need into functional and technical requirements Skilled in documentation and timely response and sharing of information Ability to perform discussion with customer Ability to effectively report on status of work Break down requirements in user stories Ability to verify the functionality in the solution. Ability to write test cases/scripts and execute them.

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...

Job Description Manager / Sr. Manager (Contract Manufacturing & Quality Compliance) Location: Pune Department: Manufacturing & Quality Reports To: Head – Operations / Quality Role Overview We are seeking an experienced and proactive professional to manage and coordinate production activities at contract manufacturing sites. The ideal candidate will have strong expertise in production planning, quality systems, regulatory compliance, and cross-functional collaboration to ensure timely supply of high-quality products in alignment with business objectives and global regulatory expectations. Key Responsibilities Production & Planning Manage and oversee production planning at contract manufacturi...

Position Summary: Freyr is seeking an experienced individual to join their Medical Device Team. This position involves working directly with clients with software enabled medical devices or software as a medical device to serve as an advisor on regulatory strategy including the development of regulatory strategy documents, documentation to support premarket submissions, and preparation and submission of premarket applications as well as participation in FDA meetings and other regulatory interactions. The role is 50% billable with the remaining time being devoted to business development/marketing as well as mentorship and training of the more junior staff. The ideal candidate will possess in-...

Interview for SVP & Injectable Pharma Plant in Bharuch on Permanent Payroll for QA, QC & Microbiologist on 07-09-2025 Exp: 3 to 8 yrs CTC: As per industry Location: Dahej Send CV on sdpbharuch@gmail.com with Subject: SVP Bharuch & Call 9727755486 Required Candidate profile No of Openings QC : 10 QA : 15 Microbiologist : 5 Exp in SVP / Injectable Plant is Must Share with Your Colleagues & Seniors No Interview & Joining Charges Project Expansion on going

Interview for SVP & Injectable Pharma Plant in Bharuch on Permanent Payroll for QA, QC & Microbiologist on 07-09-2025 Exp: 3 to 8 yrs CTC: As per industry Location: Dahej Send CV on sdpbharuch@gmail.com with Subject: SVP Bharuch & Call 9727755486 Required Candidate profile No of Openings QC : 10 QA : 15 Microbiologist : 5 Exp in SVP / Injectable Plant is Must Share with Your Colleagues & Seniors No Interview & Joining Charges Project Expansion on going

Compilation and submission of eCTD dossier for new product (Finished) application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

About IDP IDP is the global leader in international education services, delivering global success to students, test takers and our partners, through trusted human relationships, digital technology and customer research An Australian-listed company, we operate in more than 50 countries around the world, Our team is comprised of over 7,000 people of various nationalities, ages and cultural backgrounds Proudly customer-first, our expert people are powered by global technology Together, we offer unmatched services, helping local dreams become realities, all over the world, Learn more at careers idp Role purpose Key accountabilities

Perpetuity Capital is looking for AREA SALES MANAGER to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products a...

Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and cert...

Pfizer Healthcare India Private Limited - Visakhapatnam Walk - in interviews for Diploma Pharmacy Freshers Junior Associates - Manufacturing Dates & Venue: Written Assessment & Personal interview on Wednesday, 3rd Sep 2025 at 9:00 AM Interview address : Government Polytechnic College, Pharmacy Block, Kancharapalem, Visakhapatnam - 530007 Eligibility Criteria: Diploma Pharmacy only (2025 Pass out) & Pass Percentage 60% in Academic & No backlogs. Job Description Operate production equipment such as injectable machines, sterile machines, parenteral machines, formulation machines, filling machines, capping machines, compounding machines, washing machines, sealing machines, Visual inspection & pa...

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies ...

Job Description Comply with all cGMP, GxP and any other applicable regulatory requirement, including EH&S requirements. Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task. Conduct all tasks/activities as per the applicable SOPs. Report any difficulty or deviation in following the procedure/instruction to immediate supervisor/managers. Report any quality concern or suggestion for improvement to supervisors/ managers. Packing and documentation of assigned products as per instruction given in the BPR, SOP and cGMP. Handling the movement of bulk, packing material, semi-finished and finished goods as per SOP. Maintaining...

Ensures Products meet established standards by developing and implementing quality control procedures, conducting audits, monitoring performance metrics, and resolving quality issues. Maintain documentation, Ensure compliance with Pharma regulations Required Candidate profile M.Sc - B. Pharma - M. Pharma - BE - Chemical Good knowledge Of Quality Assurance Good Command over English And Computer Must be ready to face customers Inquiries And Local And US FDA Authority

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 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 - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection & Packing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspection / Packing / VI (Senior Officer / Officer / Associate) Experience - 02 to 07 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experienc...

Job Description: We are seeking a dedicated and skilled Production Officer to join our team. The ideal candidate should have a minimum of 1 year of experience in a regulatory-approved manufacturing plant, with hands-on experience in handling critical production equipment and knowledge of cGMP standards. Key Responsibilities • Operate and manage production equipment such as reactors, centrifuges, dryers, multi-mills, and other machinery used in manufacturing processes. • Oversee and ensure thorough cleaning of production areas, maintaining compliance with cleanliness and hygiene standards. • Monitor and maintain environmental conditions on the shop floor, ensuring adherence to regulatory and ...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 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 You will be aligned with our Life Scienc...

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...

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors. We have a presence in over 65 countries with our dynamic team of over 7,000 across generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI and more. Join USV and be part of our journey as we continue to innovate, transform lives, and shape the future of healthcare. Job Title: Manager / Sr. Manager (Quality Assurance) - API Only Designation - Manager / Sr. Manager - CQA - API Direct Reportees: No Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working (sometimes 2-3 d...

Led design & development/sustenance of Class II/III medical devices (electromechanical, disposable, implantable). Managed Design History Files (DHF) and ensured compliance with ISO 13485 , IEC 60601 , FDA & EU MDR . Led risk management (ISO 14971) activities including FMEA (Design & Process) and hazard analysis. Developed design inputs/outputs, V&V plans , test protocols, and technical reports. Collaborated with cross-functional teams (QA, RA, Manufacturing, Supply Chain, Clinical) for design transfer . Conducted design reviews to ensure safety, reliability, and manufacturability. Executed test method & process validations ; supported FEA coordination for design analysis. Contributed to regu...

We are seeking a detail-oriented and proactive Payroll Analyst to join our Finance Global Capability Center (FGCC) team in Bangalore. This role is critical to supporting accurate and timely processing of payroll across Oktas international, including countries in Europe and Asia-Pacific. The ideal candidate will have a strong understanding of end-to-end payroll processes, excellent coordination skills to work with regional payroll teams, global payroll vendors and other internal stakeholders, and the ability to navigate complex compliance and statutory requirements in different geographies. Key Responsibilities Support the timely and accurate payroll inputs processing and initial validation f...

We are a team of motivated employees who value the importance of our mission. No matter our role, each of us understands and connects deeply to this commitment. Hiring experienced Injectable business with expertise in Engineering and QA of the injectable manufacturing facility. Job Location: Ahmedabad Business: Quality Assurance Education: M.Pharm/M.Sc/B.Pharm/M.Pharm 1) Position: Associate, QA IPQA Experience: 3 to 8 Years Key skills: IPQA, line clearance, batch record review, in-process quality check, sampling, etc., 2) Position: Associate, QA Doc cell Experience: 3 to 8 Years Key skills: Doc control management, document and logbook issuance & retrieval, record management, CCM management, ...

Position Purpose Provide a brief description of the overall purpose of the position, why this position exists and how it will contribute in achieving the teams goal. - Support to oversee the smooth functioning of the department and ensuring consistent provision - Support To manage and motivate all departmental staff - Ensure the financial reporting to Head Office - Accounting production and statutory accounts Responsibilities - Oversee Preparation of the financial reporting sent on a monthly basis to the Head Office: P&L, balance sheet, off balance sheet, annexes, tax book, regulatory reporting schedules - Manage Prepare ad hoc Financial Reportings for Head office upon request - Contribute t...

: Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS) With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team...