933 Usfda Jobs - Page 22

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Pr...

Job Description: Formulation Development candidate - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements. Formulation Development: Design and develop OSD formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products. Perform pre-formulation studies, including solubility, stability, and compatibility evaluations. Technology Integration: Implement innovat...

JOB Description: Sound on Material (RM /PM / SPM) Receipt / Storage / Issue & Return Procedural Compliance (In Regard to GMP & SOP) Sound on GMP / GDP Guidelines GMP Operational Documentation Compliance (i.e GRN / AR No. track / Issuance / Temperature Record Maintenance / Intimation / Discard Compliance etc.) Worker Management (3 Shifts) Warehouse Management Technical / System compliance (i.e Walk In Cooler Monitoring / Equipments Handling / System Savy (JDE / DC Link)) Able to handle Regulatory Audits independently (i.e USFDA / MHRA / ANVISA / INVIMA etc.) QMS Elements Compliance and Closure on time (if any) QMS Investigation / CAPA / Impact Assessment report Drafting skills Zero” NCR Appro...

Eisai Pharmaceuticals India Pvt. Ltd. is looking for Coating & Inspection Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the ...

Role : - Assistant Manager -Vendor Management QM. Location : Baddi Company : Fresenius Kabi Oncology Ltd. Key Responsibilities : To establish, execute and monitor compliance with the procedure for the selection, qualification, development, maintenance, and discontinuation of External Providers (Suppliers of materials & services). Collection of Supplier audit needs from FKOL sites and co-ordination with FK Global Sourcing teams to finalize Global Audit Planners. Track and Execute supplier audits assigned to FK-India as per the global planner and maintain up to date status in the global External Audit Management database, with regular updates to FK Global Sourcing team. Management QA activitie...

B.Sc. / M.Sc. - Microbiology with 5 to 6 years of experience as Sr. Microbiologist. FDCA approved experience. Responsible for overseeing microbiological testing, ensuring product safety & adhering to regulatory standards, including those set by FDA. Required Candidate profile Ensuring adherence to FDA guidelines & other regulations for pharmaceutical manufacturing. Focused on quality control & compliance. Developing, validating & implementing new testing methods. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Role & responsibilities Hiring for OSD Formulation Technician- Granulation/Compression/Capsule/Coating/Compression/Packing QC/Microbiologist Supervisor- Analyst Role Preferred candidate profile B.sc/ M.SC in Chemistry, Microbiology is required for QC/Micro position ITI/Diploma Experienced Technician required Mandatory USFDA Plant Exposure required Note- Sun Pharma does not seek payment of any kind from a prospective candidates for employment with Sun Pharma or authorise any agency or any individual to collect or charge any fees or charges for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be representing Sun...

Roles and Responsibilities Manage granulation process from API to finished products (tablets, capsules) for USFDA compliance. Ensure quality control measures are implemented throughout the production process. Oversee formulation development and optimization of new products. Develop and maintain relationships with vendors to source raw materials. Collaborate with cross-functional teams to resolve issues related to productivity, yield, and quality. Desired Candidate Profile 12-20 years of experience in pharmaceutical industry with expertise in granulation, FBD, RMG, formulation, tablets, capsules. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma). Strong understanding of c...

Walk-in @ BADDI 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. Injectable Manufacturing & Packing & Visual Inspection (Executive/Senior Officer / Officer / Associate) Experience - 01 to 07 Years Qualification - B. Pharmacy/ M. Pharmacy / M. Sc /B. Sc / Diploma ENGINEERING (Instrumentation / Plant Maintenance / QMS) (Senior Executive / Executive / Senior Officer) Experience - 02 to 10 Years Qualification BE / B Tech QUALITY ASSURANCE Validation and Qualification / IPQA (injectable...

Handling and monitoring of Quality system monitoring, HACCP Activity, cGMP implementation, Audit & Compliance, Analytical QA, Vendor management, Qualification & Validation, Artwork, Recall, Training, IPQA and Document Management systems. Oversee QA documentation, QMS events, and GMP compliance. Manage deviations, CAPA, complaints, OOS/OOT, and APQR. Approve batch records, specifications, validations, and analytical reports. Lead vendor audits, technical agreements, and audit readiness. Drive training programs on GMP/GDP/GLP and quality systems. Preferred Profile: Experience: 818 years in API Quality Assurance. Education: MSc in Chemistry/related Proven track record in HACCP, cGMP implementat...

Regulatory Affairs Manager ITC Foods Location: Bangalore Experience: 10+ years We are looking for a seasoned Regulatory Affairs Manager to join our team at ITC Foods. Key Responsibilities: Lead regulatory compliance for food products across the US (FSMA, 21 CFR, USDA including NOP) , EU, GCC and other international markets which includes Regulatory and Food Safety compliances w.r.t. the Finished product, Ingredients used in Finished products, Packaging related regulation and Sustainability related aspects of importing country. Prepare and ensure compliance for raw materials , ingredients, and finished goods specifications including: Ingredient composition Contaminant & residue limits (pestic...

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...

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

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...

We are looking for Production officer candidate for Granulation Department for a leading Pharmaceuticals company at Baddi location. Candidate should have experience in handling Granulation (GLATT integrated Machine) Granulation Process Execution: Operate and monitor Glatt granulation equipment (e.g., GPCG, Fluid Bed Processor). Perform equipment setup, operation, cleaning, and troubleshooting. Ensure accurate execution of batch manufacturing records (BMRs) and SOPs. Production Planning & Coordination: Coordinate with QA, QC Maintenance, and Warehouse for smooth batch execution. Education- B.Pharma Experience- 3 to8 yrs.

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...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations 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 - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by c...

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...

Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ...

The Production Planner is responsible for developing and managing efficient production schedules to meet demand forecasts, optimize resource utilization, ensure compliance with GMP and regulatory standards, and minimize downtime in a pharmaceutical manufacturing environment. Key Responsibilities: - Develop and maintain detailed production plans based on sales forecasts, inventory levels, and customer orders. - Coordinate with procurement, quality assurance, warehouse, and manufacturing teams to align production plans. - Monitor production progress and adjust schedules as necessary to avoid delays and ensure timely product delivery. - Ensure planning aligns with cGMP, regulatory requirements ...

The Group Leader -GCP QA (Clinical) at Syngene in Bangalore is responsible for managing the GCP QA auditors team and conducting various audits related to clinical research, process audits, Investigational Site audits, and safety database audits. The role involves assessing systems and practices to improve the GCP Quality System practices in alignment with the national and international GCP Quality System standards. The Group Leader must ensure compliance with quality (GxP) regulations and standards, making the facility audit-ready at all times. Key Responsibilities include: - Scheduling and conducting GCP QA audits to ensure compliance with regulatory requirements - Developing risk-based aud...

Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia,...

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

Role & responsibilities Review and authorize change controls, assessing their impact on regulatory submissions. * Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items. * Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines. * Assess change controls from formulation plants and categorize them based on risk to product quality and compliance. * Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS). * Draft high-quality responses to regulatory agency letters (IR,...

Role & responsibilities Review of post approval changes and evaluating its impact on the products. Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports. Management of product life cycle. Managing Team Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics Preferred candidate profile 10+ Years of USFDA post approval submission experience USFDA Experience Exposure to ANDA /NDA post approval submissions Please share updated CV on hr19@hectorandstreak.com