669 Fda Jobs - Page 7

The ideal candidate brings 15-20 years 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). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 5 to 10 years 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) Additional info: Key Skills: DMF Compilation, QA Coordinat...

Micro Head based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 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). Lead mi...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years 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 improveme...

Chemist (On Contract) (MP 25/20) based in Narmada, Gujarat. The ideal candidate brings 15-20 years 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...

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...

Analysis of raw materials, in-process, finished products using HPLC, GC, UV-Vis,& titration. Maintain instruments, ensure doc as per SOPs & cGMP. Support method transfer, prepare reports,coordinate with QA and Production while ensuring lab safety.

Focus Areas: CSV: Strong knowledge of FDA, GAMP 5 , and global regulations ( US, EU, TGA ; Japan a plus) Equipment/Utility Qualification: Installation/operational/performance qualification, risk assessment, CAPA Process/Cleaning/Method Validation: Oral solid, topical, spray forms preferred Responsibilities: Lead and manage validation projects across global sites, develop SOPs and standards, ensure compliance (cGMP, ISO, WHO), perform risk and gap analyses, support audits and CAPA, and mentor site teams via COP forums. Ideal Profile: Strong in CSV plus complementary experience in equipment/utility; capable of designing validation strategies and managing cross-functional teams. Interested cand...

Role Overview: As a Regulatory Affairs Coordinator at Cipla, your primary responsibility is to ensure timely approvals from FDA (Loan License units) by coordinating with internal stakeholders and FDA teams for the submission of various applications. You will also be required to develop strong relationships with external stakeholders and advocate for licensing approvals for Cipla LL products. Key Responsibilities: - Obtain timely Regulatory Approvals from State FDA and CDSCO offices for loan license units by following up on and obtaining approvals for various applications such as fresh loan licenses, Additional product permissions, Test Licenses, India Business Tender Certificates, WHO-GMP, C...

Job Title: Executive / Sr. Executive - Quality Management System (Analytical Assurance) Department: Quality Management System Reports to: Manager Location: Ankleshwar Position Type: Full-time Qualifications And Experience Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field. Experience: Minimum 68 years of experience in Analytical Assurance within the pharmaceutical industry Job Responsibilities & Accountabilities We are looking for an experienced Analytical Assurance professional to join our team and lead the Out of specification investigation, along with core QMS activities pertaining to QC. Key Responsibilities Trigger out of specification investigations upon ...

Position Summary: Freyr is seeking an experienced individual to join their Medical Device Team. This position involves working directly with clients with software enabled medical devices or software as a medical device to serve as an advisor on regulatory strategy including the development of regulatory strategy documents, documentation to support premarket submissions, and preparation and submission of premarket applications as well as participation in FDA meetings and other regulatory interactions. The role is 50% billable with the remaining time being devoted to business development/marketing as well as mentorship and training of the more junior staff. The ideal candidate will possess in-...

What you will do In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be responsible for maintaining U.S. state and federal com...

Live What You Will Do The External Workforce Sr. Manager is responsible for supporting the management and coordination of the organization's external workforce in partnership with our Master Service Providers (MSP), including contingent workers, independent contractors, vendors, and service providers. This role will lead the planning, governance, and operational management of our external workforce to ensure the efficient use of labor categories and other external resources across the organization while maintaining compliance, optimizing cost, and enhancing workforce agility. This role works cross-functionally with HR, Procurement, Legal, IT, and department heads to ensure cost-effective and...

ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tr...

ABOUT AMGEN Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues Record and maintain w...

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations. R egulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

What you will do The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization. The AVP will lead Amgens Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, ...

Role & responsibilities Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverable...

Roles and Responsibilities: Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products. Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements. Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials. Leverage company subscriptions to provide art procurement services in support of Amgens marketing initiatives. Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, util...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

As a candidate for this position, you will be responsible for conducting QC tests of raw materials, semi-finished, and finished products to ensure compliance with FDA, GMP, ISO, and other cosmetic industry regulations. You will be expected to perform microbiological, pH testing, and thermal stability testing on cosmetic formulations and should be familiar with lab equipment. Additionally, you will investigate quality deviations, defects, and complaints, ensuring corrective actions are taken. Collaboration with R&D, Production, and Regulatory teams will be essential to maintain quality standards. You will also be responsible for maintaining product batch QC release, COA approvals, SOPs, metho...

About the Role We're looking for a highly skilled Adobe Campaign Developer with 5+ years of experience to join our growing team. This role is ideal for someone who thrives in a fast-paced environment, has a passion for marketing automation, and is eager to work with cutting-edge Adobe Experience Cloud solutions. Job Responsibilities Develop, configure, and maintain Adobe Campaign v8 including data models, workflows, and multi-channel campaign execution (Email, SMS, Direct Mail). Design and implement complex segmentation and personalization strategies. Integrate Adobe Campaign with: Adobe Experience Cloud: AEP RTCDP, Adobe Analytics, Adobe Target CRM Systems: Salesforce, Microsoft Dynamics Ex...