933 Usfda Jobs - Page 16

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 (Executive/Senior Officer / Officer) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / Msc / Bsc / Engineering - (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech QUALITY ASSURANCE IPQA (injectable) / QMS / Documentation (Officer / Senior Officer /...

Job Alert Sr. GM / Associate Vice President – Quality Control Location: North India Industry: API / Chemicals Manufacturing Salary: Open (Attractive hike on current package) Experience: 16+ Years | Age: 50 Years We are seeking a dynamic Quality Control leader for a reputed API Manufacturing organization . The candidate must have strong exposure to regulatory-driven companies with proven expertise in leading global regulatory audits (USFDA, EMA, MHRA, etc.) and managing large QC operations. Key Responsibilities: Head the Quality Control department ensuring compliance with cGMP & international regulatory guidelines. Lead a QC team of 150–200 employees , driving efficiency, compliance, and tech...

To Prepare Engineering Drawings and master list of drawings. To perform all the activities related to Engineering Department related to drawings. To perform and achieve department objectives. Awareness and documentation work of IMS, cGMP and USFDA briefly. To perform other responsibilities, as assigned by Superior(s).

To Prepare Engineering Drawings and master list of drawings. To perform all the activities related to Engineering Department related to drawings. To perform and achieve department objectives. Awareness and documentation work of IMS, cGMP and USFDA briefly. To perform other responsibilities, as assigned by Superior(s).

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

Responsible for formulation development for OSD, external preparations, oral liquids, and injectables. Responsible for pre-formulation studies, prototype development, and scale-up activities. Ensure compliance with regulatory guidelines (ICH, WHO, USFDA, etc.). Collaborate with cross-functional teams (A, C, RA, Production) for tech transfer. Mentor junior scientists and manage project timelines and documentation.

Lead engineering and project management activities for Ointment manufacturing facilities. Proven exposure in facing recent USFDA audits Guide and mentor the engineering team to deliver operational excellence. Required Candidate profile Min.10 year experience in Ointment Manufacturing USFDA-approved Plant Strong knowledge of Ointment manufacturing equipment, utilities, and automation systems. execution of plant engineering projects

Role & responsibilities Hiring for OSD Formulation Site, Mohali Punjab Production Technician & Officers ( Granulation/ Compression/ Coating/ Capsule/ Packing) Quality Control Analyst (Officer/Senior Officer) Analyst Role must have exposure-HPLC with empower software, GC & Dissolution in FG/Stability Lab Preferred candidate profile Mandatory USFDA Plant Exposure Production Technician- ITI/Diploma QC Analyst- B.SC/M.SC in Chemistry 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 ...

Hands-on experience in monitoring manufacturing and packaging processes, line clearance, and in-process checks. Proficiency in DOC-MS systems, SOP preparation, deviation handling, and change control. Involvement in TT activities including protocol review, execution, and coordination between RCD and manufacturing. Familiarity with validated software systems that meet FDA electronic records and signatures requirements. Strong understanding of equipment qualification (D, I, O, P), process validation, and cleaning validation. E-BMR G E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability. uality Management Systems (MS): Implementat...

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 / ...

This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence. Key Responsibilities: 1. Technology Transfer & Scale-up Lead the transfer of chemical processes from R&D to manufacturing. Evaluate and optimize process parameters for scale-up using mass and energy balances. Collaborate with Engineering for facility fitment, equipment readiness, and plant execution. 2. Equipment Selection & Sizing Analyse process requirements ...

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master...

Skills: 1) Hands on experience in QMS- Change Control/CAPA/Documents Control/Training Systems/Complaint Handling/Recall process 2) Batch Release 3) Audit and Self-Inspection 4) Vendor Audits 5) Compressed Air and Water System Validation

JD: 1. To assist in implementing and maintaining quality management system. 2. Conducting audits and inspections, analysing quality data and ensuring compliance with regulatory standard. 3. Including leading QC teams, overseeing raw materials and and finished products. 4. Managing corrective actions, preparing reports and driving continuous improvement process quality. 5. Regular internal QC inspection to assess complies and identify quality issues and pinpoint areas for improvement. 6. Manage and guide quality control analysts and technicians, providing training and support to ensure team performance. 7. Work closely with cross-functional teams, including production and engineering, to reso...

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

To operate and monitor granulation equipment and processes in compliance with cGMP, SOPs, and safety standards, ensuring consistent production of high-quality pharmaceutical granules for tablet or capsule formulation. Key Responsibilities: Operate granulation equipment such as high-shear mixers, fluid bed dryers, oscillating mills, and blenders. Weigh, dispense, and mix raw materials as per batch manufacturing records (BMR). Monitor granulation parameters and adjust settings to maintain product quality. Perform in-process checks (e.g., moisture content, granule size) and document results accurately. Clean and maintain equipment and work areas as per SOPs. Execute machine changeovers and line...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Job Description: FDA Manager Food/FMCG (15-20 yrs) Position: FDA Manager Department: International Business Timings: 12:00 Pm to 9:00 pm We are looking for a seasoned US FDA Clearance Manager with 1520 years of experience in Regulatory Affairs & Compliance for Food/FMCG, with a strong focus on the US market. Key Responsibilities: Lead all USFDA clearance, approvals & compliance processes. Ensure adherence to 21 CFR, FSMA, FSVP, labelling & packaging norms . Manage dossiers, regulatory submissions & audit inspections. Guide cross-functional teams (R&D, QA, Production, Exports). Liaise with USFDA, certification bodies, distributors & consultants. Qualification & Experience Degree in Food Tech/...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Coordinate with various departments to ensure seamless operations and resolve issues. Implement and maintain quality control measures to ensure high standards. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven experience in operations management with a minimum of 5 years of experience. Strong knowledge of operational principles and practices. Excellent leadership, communication, and...

Analytical method development Analytical method validation Stability studies Extractable and leachable Standards generation Calibration of Instruments All related works as per USFDA and NABL norms

Role & responsibilities Procurement & Sourcing: Source APIs from qualified US Market suppliers. Maintain relationships with existing vendors and identify new suppliers. Evaluate supplier credentials and ensure regulatory compliance (e.g., GMP, USFDA, EUGMP). Negotiation & Cost Management: Negotiate prices, payment terms, delivery schedules, and contracts. Work with finance and production departments to manage cost-effectiveness. Inventory & Planning: Monitor stock levels and forecast needs based on production plans. Coordinate with production and warehouse teams for timely delivery. Compliance & Documentation: Ensure all procurement activities comply with regulatory and quality standards. Ma...

Role & responsibilities Procurement & Sourcing: Source APIs from qualified US Market suppliers. Maintain relationships with existing vendors and identify new suppliers. Evaluate supplier credentials and ensure regulatory compliance (e.g., GMP, USFDA, EUGMP). Negotiation & Cost Management: Negotiate prices, payment terms, delivery schedules, and contracts. Work with finance and production departments to manage cost-effectiveness. Inventory & Planning: Monitor stock levels and forecast needs based on production plans. Coordinate with production and warehouse teams for timely delivery. Compliance & Documentation: Ensure all procurement activities comply with regulatory and quality standards. Ma...

- Key Responsibilities Plan, organize, and monitor manufacturing operations to ensure timely and efficient production and dispatch of pharmaceutical formulations with accurate yield and reconciliation. Ensure compliance with cGMP norms and regulatory standards including WHO, EU GMP, PICS, TGA, MHRA, and USFDA on the shop floor. Lead process validation activities to ensure manufacturing processes meet quality and regulatory requirements. Collaborate with QA and QC departments on handling product complaints and recall analysis. Manage production schedules, coordinate with supply chain, and optimize resource utilization to meet business goals. Oversee production team performance, training, and ...

Key Responsibilities Lead and manage the Quality Assurance department, ensuring compliance with GMP norms and regulatory requirements of WHO, EU GMP, PICS, TGA, MHRA, USFDA, and other global agencies . Develop, implement, and monitor Quality Management Systems (QMS) across all QA functions. Ensure strict adherence to SOPs and continuous improvement practices in line with regulatory expectations. Oversee handling of rejected materials, market complaints, product recalls, deviations, change controls, CAPA, and CCF . Manage end-to-end Validation and Qualification activities (process validation, cleaning validation, equipment qualification, analytical method validation, etc.). Ensure audit readi...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Collaborate with cross-functional teams to align with organizational goals. Ensure compliance with regulatory requirements and industry standards. Foster a culture of continuous improvement and excellence within the team. Job Requirements Proven experience in operations management with a minimum of 8 years of experience. Strong leadership and management skills, with the ability to motivate and inspire teams. Excellent analytical and p...