FDA Jobs

Handling of QA Documentation.Drafting of products permission, COPP, MMC.Review of BOM.

Key Responsibilities:1. Ensure compliance with medical devices regulations: As a biomedical trainee, you will be responsible for ensuring that all medical devices and equipment meet the necessary regulatory standards and guidelines.2. Assist in conducting clinical trials: You will support the team in planning and executing clinical trials to evaluate the effectiveness and safety of new medical devices.3. Manage CE certifications: You will help in obtaining and maintaining CE certifications for medical devices, ensuring they meet European regulatory requirements.4. Support FDA submissions: Assist in preparing and submitting documentation to the FDA for approval of new medical devices or modifications to existing ones.5. Assist in patent applications: Help in researching, drafting, and filing patent applications to protect the intellectual property of new medical devices.6. Assist in ISO certifications: Support in obtaining and maintaining ISO certifications for quality management systems related to medical devices.7. Assist in devices calibration: Help in calibrating medical devices to ensure accurate and reliable performance.Required Skills and Expectations:- Post Graduate Diploma or M.Sc in Biomedical Engineering or related field.- Knowledge of medical devices compliances and regulations.- Strong attention to detail and ability to follow strict protocols.- Familiarity with CE certifications, FDA regulations, patent processes, ISO standards, and devices calibration.- Excellent communication and teamwork skills.- Ability to work under supervision and learn quickly in a fast-paced environment.

In the paper industry, Quality Assurance (QA) plays a crucial role in ensuring consistent product quality, meeting customer requirements, and complying with industry standards. QA focuses on preventing defects and refining manufacturing procedures throughout the production process.Job Description:Quality Control: Involves regular checks and measurements during production to ensure products meet specified qualities, often incorporating Total Quality Management (TQM).Testing and Measurement: Utilizes various testing instruments and methods to assess physical and chemical properties of paper and its products, including thickness, density, tear strength, and burst strength.Process Control: Involves monitoring and adjusting various parameters during the papermaking process to maintain consistency and optimize performance.Raw Material Inspection: Ensuring the quality of raw materials like pulp, fibers, and chemicals used in paper production.Continuous Improvement: Regularly reviewing and improving QA procedures to enhance product quality, reduce waste, and optimize operational efficiency.Compliance with Standards: Adhering to industry standards and regulations, such as ISO 9001:2000, to ensure quality and safety.Data Analysis and Management: Utilizing data from online systems and web inspection systems to analyze roll quality and identify areas for improvement.Preferred ExperienceCandidates with experience in the following industries will have an added advantage:Paper Mills and Paper ConversionFood PackagingWhy Join Nationwide Paper Ltd?Be part of a global leader in sustainable packaging solutions.Opportunity to work in a fast-paced and innovation-driven environment.Professional growth opportunities and competitive compensation.

A Business Development Manager will be responsible for managing all operations within a country. This involves taking responsibility for profit, revenue, cash and quality targets. In the Corporate Relocations and International Removals Sector, a Business Development Manager job may include being in charge of many areas of the business such as Business development, Channel/Network Development, high level customer service, Strategic Planner, Strong Brand Marketing Planner and Ability to Implement, Country Product registration knowledge. Agreeing annual budgets and producing a detailed annual business operating plan are tasks a Business Development Manager may have to deliver as well as monthly, quarterly or annual targets for revenue, profits and cash. They are expected to recruit and manage staff, including performance monitoring, and possibly mentoring and training. The role is client facing and so daily contact with clients is a big part of a Business Development Manager job, therefore the ability to communicate effectively is essential.What key skills and qualifications?A Business Development Manager job demands a broad range of business skills including: Must be educated to degree level or equivalent, understanding of budgeting and Business planning is essential as this role involves agreeing annual budgets and targets A Business Development Manager job requires a strong understanding of how a business operates and successful candidates will have a proven track record demonstrating their understanding and business acumen. General management And FMCG Operation management Excellent customer service.. Confident, Matured, Flexible, Ability to Learn new dynamics and upgrade themselves to new country and position. Should understand sensitive culture difference and be a strong team leader and provide proper guidance to the team.. MS Office advance level must, Digital marketing and Online business knowledge need.

Title - Product Security Engineer & Cyber Security Engineer with a combination of Medical Devices & Software development. Location - RemotePreferred Qualifications: Medical Systems Knowledge: Experience with medical information system administration and familiarity with medical device security standards and regulations (e.g., FDA Premarket Cybersecurity Guidance, IEC 81001-5-1, AAMI TIR57, AAMI SW96).Regulated Industry Experience: Experience in software development and verification within a regulated industry.Technical Support Experience: Experience providing technical support to field service teams and/or end-users.Certifications: Security-related certifications (e.g., CISSP), OS (Windows, Linux), and networking (Cisco) certifications are strongly preferred.DoD Certification: Experience obtaining and maintaining Department of Defense (DoD) Authority to Operate (ATO) certifications.Team Lead Experience: Experience supporting a team of security engineers.Cloud Compliance: Experience in obtaining and maintaining industry-recognized certifications such as SOC 2, HITRUST, and FedRAMP.

Production Operations Management:Quality ControlSupply Chain and Inventory ManagementCompliance and Safety:Process Improvement:Leadership and Team Development:Human Resource Management

Conducting visual inspections of products or materials to identify defects or inconsistencies. Assisting with the execution of quality control tests and procedures. Using quality control equipment and software to analyze and improve standards. Documentation and Record Keeping:Accurately documenting inspection results and test data. Maintaining records of quality control activities and findings. Adhering to Quality Standards:Ensuring that products and processes meet established quality standards and specifications. Identifying and reporting any deviations or non-conformances.

Prepare, review, and maintain SOPs (Standard Operating Procedures), validation protocols, batch records, and other quality documents.Ensure compliance with cGMP, FDA, MHRA, WHO, and other regulatory guidelines.Conduct document control activities, including version control, issuance, retrieval, and archiving.Support internal and external audits by providing required documentation.Assist in equipment qualification (IQ, OQ, PQ) and validation processes.Coordinate with the QA/QC team to implement corrective and preventive actions (CAPA).Maintain training records for personnel involved in quality and compliance functions.Monitor and update quality documentation systems to enhance efficiency.

URGENT REQUIREMENT WORKING HOURS - 9:30 - 6- basic accounts working experince - transfering the data ( fda ) - working experince in excel - basic knowledge of accounts / tally / ERP systems( FEMALE CANDAIDATES )JOB LOCATION - VASAI EAST ( VALIV )( CANDIDATES FROM BORIVALI-VIRAR CAN APPLY

Business CanSat Consulting is an experienced and affordable quality, regulatory, and licensing consulting firm. We cater to the needs of Psychedelics, Food, Medical Devices, Natural Health Products, and other related industries.Nature & Scope of Position Reporting to the Principal Consultant, the primary responsibility of the Compliance and Quality Associate is to prepare licensing applications, research Acts and Regulations, review batch records, write non-conformance and CAPA reports, and coordinate with clients and others. The candidate must have strong communication and interpersonal skills and must hold to the highest level of integrity and confidentiality. The successful candidate depending on their skills, experience, and performance would also have the opportunity to take part in profit sharing.General Duties & Responsibilities Coordinating with clients and ensuring their operation is compliant with applicable acts and regulations. Assist with the preparation of licensing applications associated with Cannabis, Food, and pharmaceutical industries in Canada and the USA. Ensure that all SOPs and specifications for each procedure are appropriate and followed by the concerned personnel. Review the batch records and release products in accordance with all applicable SOPs and regulations. Conduct internal inspections and gap assessments. Ensure that appropriate manufacturing in-process controls are implemented. Review all documents that describe work instructions and set requirements such as procedures, protocols, test methods, specifications, etc. Ensure all non-conformances, customer complaints, and out-of-specifications are investigated, and root causes are found. Perform employee training for GMP, SOPs, and new positions as required by the client.

To review the documentation of manufacturing and packaging.Retrieve electronic scans and review batch records based on cGDP, cGMP, CPCs SOPs, and FDA guidelines.To perform batch data entry for APR and process validation.Preparation of Annual Product Review / Product Quality Review reports.To review the process validation report.

Designation : Sr. Manufacturing Chemist (Injectable) Education : The candidate should have minimum P.G. degree (M. Sc or B. Pharm/ M. Pharm)Experience : Mandatory Pharma Industry experience of 6 years or moreSalary :4 to 8 LPA Location : Faridabad, Haryana Job Roles and Responsibilities Should have Approved by FDA Must possess minimum basic knowledge on Peptides and possesses expertise in the manufacturing of Topical solutions, Injectable, Tablet, Capsule, Syrup, Ointment etc Thorough knowledge in Schedule M, GMP, and CGMP practices Experience in various regulatory and 3rd party audits Must be in a position to accomplish the work independently with minimum subordinate staffs.

R/M & P/M Dispensing, Reconciliation, Calculation mfg. of Injectable plantWashing Area Monitoring, ONLINE BMR, Logbook, formats, SOP, must have working in Autoclave, Vial, Ampoule, DHS M/c, DecodingManpower HandlingDocumentation & Formats, SOPRequired Candidate profileB. Sc. /B. Pharm/M.Sc/M.Pharm with injectable mfg - Responsible for Injectable Sterile, Aseptic mfg of pharma - formulation injectable plant, must have knowledge of Audit Documentation, Responsible for SOP.

Candidate should be FDA approved particularly in sterility and opening is at Tarapur MIDC Palghar .

Duties and Responsibilities: Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop Data Management Plans that will deliver accurate, timely, consistent, and quality clinical trial data. Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs). Primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects. Primary contact person for communication and discussion of topics related to data management timelines and deliverables, request for out of scope tasks, and first line contact for technical or procedural issues. Responsible for planning and implementing data management timelines and deliverables, for providing database and data management activities status reports, and contributes to the overall project planning, progress tracking and reporting. Design and review electronic Case Report Forms (eCRFs). Develop and review eCRF Completion Instructions. Generate and review annotated eCRFs. Develop and maintain data validation specifications. Fully involved in the clinical study database User Acceptance Testing (UAT), and ensure proper documentation thereof. Manage the process of database modifications (after go-live) due to protocol amendments or study needs. Regularly communicate and/or respond to data collection sites, third party service providers, and when appropriate sponsors; responding to queries in a timely manner,Qualifications: A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company. In-depth understanding of database structures and database programming. In depth knowledge of CDISC SDTM/CDASH standards. In-depth knowledge of clinical trial processes and experience in ICH, GCP, and GCDMP (SCDM

Designation : Sr. Manufacturing Chemist (Injectable) Education : The candidate should have minimum P.G. degree (M. Sc or B. Pharm/ M. Pharm)Experience : Mandatory Pharma Industry experience of 6 years or moreSalary :4 to 8 LPA Location : Faridabad, Haryana Job Roles and Responsibilities Should have Approved by FDA Must possess minimum basic knowledge on Peptides and possesses expertise in the manufacturing of Topical solutions, Injectable, Tablet, Capsule, Syrup, Ointment etc Thorough knowledge in Schedule M, GMP, and CGMP practices Experience in various regulatory and 3rd party audits Must be in a position to accomplish the work independently with minimum subordinate staffs.