933 Usfda Jobs - Page 28

Job Role : General Manager (Engineering) Education: BE Electrical & Electronics Experience : 22 to 24 Yrs (with expereince in Regulated markets and Sterile background) Responsibilities : 1. He is authorize to sign (as a doer / reviewer / verifier) A. Engineering GMP Documents B. Break Down / Preventive Maintenance Report C. Qualification Documents. D. QMS document review and closing. E. Any other documents related to QMS. Handling of Halol-1 (NOSD) Engineering Operation, HVAC, Electrical and Facility Management related activity. Preventive Maintenance approval, Instrument / Equipment inward approval, Qualification protocol and SOP review and approval. Improvements to reduce the Break down ti...

We are looking for a skilled Regulatory Engineer with 4 to 8 years of experience to join our team at Apptad Technologies Pvt Ltd. The ideal candidate will have a strong background in regulatory affairs and excellent analytical skills. Roles and Responsibility Develop and implement regulatory strategies to ensure compliance with industry standards. Collaborate with cross-functional teams to identify and mitigate regulatory risks. Conduct thorough analysis of regulatory requirements and develop effective solutions. Prepare and submit regulatory documents to relevant authorities. Monitor and report on regulatory changes that may impact the company. Provide training and guidance to internal stak...

Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have a flexible Required Candidate profile RA role in medical device,US FDA,EU Bachelor degree in Medical,Mechanical,Electric Life Science/other healthcare related majors 8yrs exp for RA role in medical device/pharmaceutical industry

THE POSITION: We are looking for a Data entry Analyst to update and maintain Pharmaceutical global tenders’ information. ESSENTIAL DUTIES AND RESPONSIBILITIES: Data Entry responsibilities include collecting and entering data in databases and maintaining accurate records. Compile, verify accuracy and sort information according to priorities to prepare source data Review data for deficiencies or errors, correct any incompatibilities if possible Research and obtain further information from documents Store completed work in designated locations and perform backup operations Comply with data integrity and security policies They can perform repetitive tasks with a high degree of accuracy in an eve...

Lead a team to drive excellence in investigation, compliance, and continuous improvement. • Continuously improve capabilities for manufacturing operations. • Prioritize timely investigation and operational improvement with a strong focus on results. • Identify root causes using the right investigation tools and implement effective CAPA (Corrective and Preventive Actions). • Work on procedural gaps to prevent deviations. • Develop a compliance mindset within the team. • Strengthen integrity and right-first-time culture within the team. • Identify improvement opportunities in processes and procedures, removing non-value-added steps. • Use operational excellence tools to identify and minimize a...

Role & responsibilities Preparation and review of standard operating procedure. Monitoring of trend in the process and in the quality control. Preparation of Annual product quality review (APQR). Preparation of validation protocol & report. Reviewing of equipment qualification. To support the customer / regulatory audits. Follow up of CAPA. Handling of customer complaints. To support the preparation of new drugs endorsement / manufacturing license documents. Reviewing of stability data and monitoring of trend. Upkeep of documentation. Issue and control of documents. Issue batch production record. Issue and Retrieval of cleaning records. Review of batch production and equipment cleaning recor...

Position: Senior Officer Job Title: Senior Officer Job Grade: Function: Corporate Quality Compliance Sub-function: Complaints Manager s Job Title: Senior Manager-1 Skip Level Manager s Title: Function Head Title: Head of Global Quality Systems Complaints Location: Vadodara No. of Direct Reports (if any) Nil Job Summary Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Review of Product Quality Complaint Investigation Reports (India Market). Coordinate with other stakeholders involved in the complaint handling process. Areas of ...

Berger Paints India Ltd ( British Paints Div ) is looking for Area Sales Manager - Prolink 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 whi...

Bulk Drug, API Production. SOPs, cGMP, Reactor, BMR Review, Raw Material Hydrogenation, batch production Key member of troubleshooting the production of an FDA license product In process checking on various intermediate steps Developing new production methods or improving existing ones to increase efficiency or quality of product maintenance and repairs of equipment used in production processes Active calculation batch reconciliation on various stages To be responsible for Batch start up activity, monitoring, calibration of balance and other instruction given by the Superior. To review technical documents like batch records, cleaning records, validation protocols, cleaning verification proto...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with s...

Walk-in @ GOA We are hiring multiple positions for our manufacturing facility at AHMEDABAD 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. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / Market Compliance / IPQA - (injectables) (Officer / Senior Officer / Executive/Senior Executi...

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreeme...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: BCom/B.B.M 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 operations ...

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 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 Embedding digital transformation in healthcare operations ...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: BCom Years of Experience: 1 to 3 years Language - Ability: English(Domestic) - 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 do Embedding digit...

Core Java/ JSP /EJB (SE/SSE Positions)-Chennai Posted On 30th Nov -0001 12:00 AM Location Chennai Role / Position SE/SSE level Core Java Engineers Experience (required) 3-6 Years Description Our client is the number one outdoor advertising company worldwide, the market leader in Europe and number 1 in Asia Pacific.Our client is looking for Asst Manager-Maintenance Candidate Profile Real estate experience in primary sale for at least 2-3 years Should have good communication skills Our client is one of the leading global real estate firms having offices across the world. Assistant Manager Send Resumes to girish.expertiz@gmail.com -->Upload Resume

Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Cli...

BSC / MSC Chemistry / Bpharm / Mpharm 6 to 10 Years CTC: 8 LPA Send CV on sdpbharuch@gmail.com with Subject: RA Vadodara Experience in Formulation Pharma Company is Must Free Jobs Share with Your Friends & Colleagues Required Candidate profile Follow: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ

The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs ...

The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs ...

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audi...

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAM...

: - Excellent knowledge of products Manufacturing of Colour Cosmetics personal care, Skincare, Cream, Shampoo, Hair Oil, Conditioner, Face Wash, Body Wash, Body Lotion and Foot Care ,Lipstick, Nail Polish Etc. Lay down procedure to implement GMP & GLP norms and ensure documentation & compliance Define AQL for incoming raw material and components Develop vendor base to meet cost, quality (manufacturing and product), and innovation requirements Development of new formulation as per the business demand Preparation of documents & Registration of product, label compliance with regulatory authorities - local & overseas. Skills :- Must come from the personal care background. Worked for the majority...

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC/GC 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) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784