669 Fda Jobs - Page 6

HVAC & Water System Engineers 2 Posts based in Amritsar. The ideal candidate brings 2 - 4 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen)...

Autocad Operator 1 Pos based in Amritsar. The ideal candidate brings 6-7 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Operate and tro...

Role & responsibilities Enforcing consistency in quality of supplies from RM & PM Vendors by tracking their performance & system implementation Ensuring implementation of Quality management system as per CQA guidelines. Conducting Internal Quality Audit as per ISO & Internal Standards - preparing reports, scoring and periodic reviews Ensure New Product Development prototype, launch and stabilization Ensure smooth implementation of QMS and 3M modules in SAP Ensure adherence of Legal Norms related to Statutory Bodies (FDA & Ayurvedic) Establishing & managing systems for legal compliance (AGMARK / PFA / MPCB / Metrology) Ensuring implementation of TPM, 5S and Lab Standardization at Plant Procur...

Role & responsibilities A Packing Head in the nutraceutical industry oversees all packaging operations, ensuring that products are packed efficiently and in compliance with strict quality and regulatory standards . The role involves strategic planning, team leadership, and process optimization to meet production targets and maintain product integrity. Core responsibilities Operational management: Lead and supervise the packaging department's daily activities, including planning and executing packing schedules to meet production demands. Quality and compliance: Enforce and uphold Good Manufacturing Practices (cGMP), FDA, and other relevant regulatory requirements. Review and approve batch pac...

Role & responsibilities Role Overview You will ensure that all natural food colour raw materials, in-process samples, and finished goods meet quality and regulatory standards. The role involves routine testing, documentation, and compliance support to maintain consistent product quality. Key Responsibilities Conduct routine analysis of raw materials, intermediates, and finished natural colour products. Test and validate key parameters (colour value, pH, solubility, stability, microbiological safety, heavy metals, etc.). Generate and review Certificates of Analysis (COA) for customer dispatches. Maintain and calibrate laboratory instruments (HPLC, UV-Vis spectrophotometer, TLC, GC-MS, etc.). ...

Responsibilities: Develop & implement quality systems using ISO13485, Six Sigma Green Belt, ISO9001. Conduct audits, manage CAPAs, ensure FDA/QSR/MDR compliance. Work closely with R&D for (NPI) to ensure quality planning (DFMEA, PFMEA, Control Plan)

Roles & Responsibilities Conduct post-market data analysis (complaints, adverse events, service reports, literature, vigilance data). Prepare and maintain PMS reports, PSURs, and trend analyses. Support risk management updates and product safety evaluations. Collaborate with cross-functional teams for CAPA and field actions. Ensure compliance with EU MDR, ISO 13485, and ISO 14971 requirements. Support audit and regulatory submission activities. Qualifications Bachelor’s degree in Engineering, Medical, Biomedical, or related field. 3–5 years’ experience in PMS, complaint handling, or post-market quality (medical device preferred). Strong knowledge of EU MDR, ISO 13485, and vigilance reporting...

Roles & Responsibilities Develop and execute biocompatibility evaluation plans and reports. Assess material composition, manufacturing processes, and potential biological risks. Coordinate testing with external laboratories and review study protocols/reports. Support risk assessments and justification for biological safety. Ensure compliance with ISO 10993 series, FDA, and EU MDR requirements. Collaborate with R&D, Regulatory, and Quality teams for product development and change control. Maintain documentation and support regulatory submissions. Qualifications Bachelor’s/Master’s in Biomedical, Materials, or Chemical Engineering, or related field. 5+ years’ experience in biocompatibility or ...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Description Regulatory Manager (CMC, EU Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

You will be joining the Sandoz Development Center in Hyderabad as an experienced Scientist specializing in Materials Science. Your primary focus will be on the characterization of Active Pharmaceutical Ingredients (APIs), preformulation, and deformulation using advanced solid-state technologies such as SEM, IR & Raman microscopy, DSC, BET, DVS, PSD, XRD, etc. Your expertise in XRD and PSD method development, validation, and transfer will be crucial. Additionally, you must possess knowledge of quality, compliance, and regulatory guidelines (e.g., ICH, FDA) and have strong communication, presentation, teamwork, and problem-solving skills. This role will allow you to contribute to innovative ph...

Role Overview: Working at Bristol Myers Squibb is a unique and rewarding experience where you will have the opportunity to engage in meaningful work that impacts the lives of patients worldwide. As a Computer System Validation Lead in the Digital Manufacturing EMES team, you will play a crucial role in ensuring compliance and validation for the Manufacturing Execution System (Syncade) to support BMS" global manufacturing operations. This position offers the chance to work with high-achieving teams and grow through diverse opportunities uncommon in scale and scope. Key Responsibilities: - Develop and implement the test automation strategy, aligning with project goals and timelines. - Design, ...

Concept Pharmaceuticals Ltd. is looking for Clinical Data Manager to join our dynamic team and embark on a rewarding career journey Data Collection and Entry: Oversee the collection and entry of clinical trial data into electronic databases, ensuring accuracy, completeness, and compliance with regulatory requirements Data Cleaning: Perform data validation, verification, and quality control procedures to identify and resolve discrepancies or errors in the data Database Design: Contribute to the design and development of electronic data capture (EDC) systems and databases for data collection and management Data Standardization: Ensure data standardization and adherence to data collection stand...

Concept Pharmaceuticals Ltd. is looking for Clinical Research Associate to join our dynamic team and embark on a rewarding career journey As a Clinical Research Associate (CRA), you will be responsible for monitoring clinical trials and ensuring that they are conducted in accordance with regulatory requirements and ethical standards Ensure compliance with study protocols, regulatory requirements, and ethical standardsMonitor and review study data to ensure accuracy, completeness, and compliance with study protocolsStrong knowledge of clinical research protocols, regulations, and guidelines, including ICH-GCP and FDA regulations Proficiency in using clinical research software, such as EDC sys...

Role & responsibilities Build the QMS end to end to ISO 13485:2016 : perform gap analysis, draft SOPs/WIs, deploy training, run Stage 1/2 audits and close nonconformities to achieve certification. Own Design Controls & Documentation: create/maintain SRS, DHF, DMR, Risk Management File (ISO 14971) , software lifecycle records (IEC 62304), trace matrices and labelling; ensure change control discipline. Regulatory Strategy & Submissions: chart and execute stepwise pathways CDSCO manufacturing licence & device registration first, then FDA 510(k) and EU MDR CE Mark ; prepare technical documentation/dossiers and coordinate with test labs, auditors and notified bodies. Audits, CAPA & Metrics: plan ...

Job Title: Formulation and Development Executive Cosmetics Division Company: Isha Agro Developers Pvt. Ltd. – (Brand - Herbal Hills) Location: Lonavala, Maharashtra Department: Cosmetics Manufacturing Experience: Minimum 3 to 5 years Qualification: B.Tech/M.Tech/M.Sc in Cosmetic Job Summary: We are seeking a skilled and innovative Formulation and Development Executive for our Cosmetics Division at Herbal Hills. The ideal candidate will be responsible for developing, testing, and improving cosmetic formulations in alignment with market trends and regulatory standards. Key Responsibilities: Develop and optimize formulations for skincare, haircare, and personal care products. Conduct stability ...

,in-processthe ,for leading,for leading,problem-solvingResponsibilities We are looking for a senior professional AGM with a range of 15 to 20 years of experience in Analytical Method Validation for regulated markets. The role involves leading API and excipient method validation across multiple dosage forms and managing a team of 30, including three senior managers. The ideal candidate must be technically strong, experienced in US/EU compliance, and hold an M. Pharm, M.Sc., or Ph.D. Role & responsibilities: Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Responsible for RM & PM characterization and documentation. Generate qualificat...

JD:- We have an exciting role of Submission Specialist (MLR+EMA) to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About US We are an integral part of Annalect Global and Omnicom Group, one of the largest media and advertising agency holding companies in the world. Omnicoms branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations, and other specialty communications services. Our agency brands are ...

Job Title: Clinical Product Owner/Scientist Location: Bangalore Experience: 10+ years Role Overview: We are seeking a visionary and accomplished Medical Device Clinical Product Owner to lead our new product development initiatives in Healthcare and Life sciences. This role combines deep functional expertise with strong leadership and business acumen. The ideal candidate will have a proven track record in conceptualizing, evaluating, and developing medical systems. You will liaison with medical practitioners, OEM partners and cross-functional engineering teams to guide solution development and implementations. This is a customer-facing role with a strong focus on innovation, solution developm...

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Follow Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Review scientific literature and patents to identify new product development opportunities. Required Candidate profile Specialty Chemicals / Excipients / Pharmaceutical Field Whatsapp CV on 9724346949

Responsibilities: Documentation & Record Review: Review specifications, sampling instructions, test methods, and analytical reports. Review and approval of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR), and Equipment Qualification Records. Review completed Batch Production Records and Laboratory Control Records post-batch completion. Review analytical data, Calibration & Preventive Maintenance schedules, and external audit reports. Review and finalize Certificate of Analysis (CoA) for finished products. Review Draft Equipment Cleaning Records and Hold Time Study protocols/reports. Review Standard Operating Procedures (SOPs) and Annual Product Quali...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for mo...

Job Description: Responsible for leading and managing all regulatory activities for the Indian domestic market to ensure timely product approvals, license renewals, and compliance with CDSCO and State FDA regulations. Key Responsibilities: • Oversee submission, approval, and renewal of product licenses, manufacturing, and marketing authorizations. • Ensure compliance with Drugs & Cosmetics Act, Schedule M, and other applicable regulations. • Liaise with CDSCO, State FDA, and other regulatory authorities for product-related matters. • Review and approve dossiers, product artworks, and labelling as per regulatory norms. • Monitor changes in drug regulations and implement necessary updates. • G...