397 Fda Jobs - Page 3

As a Project Engineer specializing in pharmaceutical machinery manufacturing at CoralPT Worldwide Pvt. Ltd., located in Ankleshwar, Gujarat, you will play a crucial role in managing projects from inception to completion with a focus on quality, efficiency, and adherence to industry standards. Your expertise in Blenders, Stainless steel reactors, fluid bed dryers, RMG/HSMG, Tray dryers, and other pharmaceutical equipment will be instrumental in ensuring the successful design, development, and execution of projects related to pharmaceutical machinery. Your key responsibilities will include overseeing the installation, commissioning, and validation of equipment, collaborating with cross-functio...

We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...

Were Hiring | Sr. Executive – New Product Development at Rage Coffee At Rage Coffee, we’re not just building products—we’re creating experiences for coffee lovers across the world. Our mission is to redefine how people consume coffee by blending innovation, quality, and creativity into every sip. Now, we’re looking for a passionate Sr. Executive – Product Development to join our team and help us take our product journey to the next level. Location: Gurugram Experience: 4–8 years What you’ll be doing: *Lead and execute new product development projects from ideation to launch *Partner with cross-functional teams—marketing, operations, supply chain, and sales—to bring innovative concepts to lif...

International Solar Alliance is looking for REGULATORY SPECIALIST to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistant...

Warm Greetings from SP Staffing Services Pvt Ltd!!!! Experience Required: 1 to 8 Years Location: Pune/Mumbai/Hyderabad Employment Type: Full-Time Job Description: Hands-on experience in JD Edwards EnterpriseOne technical development. Strong command over JDE toolsets: FDA, RDA, UBE, BSFN, NER, BSSV, and Orchestrator. Experience in Object Management Workbench (OMW) and Change Management. Good understanding of table structures, data dictionaries, and interdependencies in JDE. Knowledge of SQL, PL/SQL, and JD Edwards database structure. Exposure to CNC concepts is a plus. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Design, develop, test, and im...

You are invited to join a German Based MNC in Bangalore as a Validation Engineer with a focus on Installation and Qualification of Pharma Machinery. This exciting opportunity requires 3-6 years of experience, offering a competitive CTC of 6-8 LPA. The location for this role is Hebbal, Bangalore, and candidates must be open to both domestic and international travel. Your responsibilities will include ensuring that qualification projects meet customer requirements, clarifying customer qualification needs during kick-off meetings, and documenting agreements in the Qualification Master Plan (QMP). Additionally, you will moderate and document risk analyses, create various test documents, conduct ...

As a Clinical Data Management (CDM) professional, you will be responsible for overseeing the full lifecycle of clinical data management processes. Your role will involve ensuring the quality and integrity of clinical trial data, developing and implementing data management plans, and monitoring data entry and validation processes. You will coordinate with clinical teams to ensure timely data collection and conduct data cleaning and review activities. Additionally, you will be preparing data for statistical analysis and reporting while ensuring compliance with regulatory requirements and industry standards. Participating in protocol development and study design, utilizing data management softw...

The primary responsibilities of this role include ensuring the quality of all incoming PM, RM, in-process materials, stability samples, and finished products. You will be responsible for sampling and testing all PM, RM, in-process materials, and finished products within the specified lead time. Additionally, you will be expected to prepare testing reports in a timely manner and ensure correct labeling on materials such as sampled, approved, and rejected. You will also be responsible for sampling and testing raw water and purified water as per specifications. Other responsibilities include checking the dye strength of stock color solutions, verifying preservative traces in equipment used for ...

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...

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)...

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...

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...

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...

Chief Manager Training Centre (MP 25/14) 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/Lea...

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...

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...

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory require...

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...

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-...

You will be responsible for preparing and adhering to the annual planner for Quality audits for Loan Licence Units (LLU), Third-Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs) to ensure GMP and GLP compliance. This includes conducting periodic, due diligence, and for-cause quality audits to monitor overall performance. You will review audit compliance reports for any external, regulatory, or customer audits, ensuring the closure of individual observations by reviewing relevant supporting data. Additionally, you will conduct self-inspections of individual departments, compile reports, track and review compliance for timely closure, and maintain audit ...

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...

Develop business for Excipients & Fine chemicals with pharmaceutical Liaise with Pharma companies Prepare techno-commercial proposals Address customer queries Monitor market trends Maintain and update customer databases Ensure all documentation Required Candidate profile knowledge of pharma excipients & APIs Strong documentation handling skills (compliance, quality certifications, VQ’s) Customer relationship management Strong communication Proficiency in MS Office

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You should be able to recognize patient needs and prioritize those needs with the requirements outlined by physicians. Responsibilities - Assure quality care by adhering to standards set by the physicians. - Provide care education to patients in person or over the phone. - Adhere to compliance guidelines throughout processes (OSHA, FDA, HIPAA). Qualifications - Must be a Registered Professional Nurse with current licensure. - CPR, ACLS, and BCLS Certification. - Knowledge of OSHA, FDA, and HIPAA compliance. - You must be able to lift and position patients on an endoscopy stretcher a...

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You will be expected to recognize patient needs and prioritize them in alignment with the directives provided by physicians. Your role will involve assuring quality care according to the standards set by physicians, providing education on care to patients either in person or via telephone, and ensuring compliance with guidelines such as OSHA, FDA, and HIPAA throughout the processes. To qualify for this position, you must hold a current licensure as a Registered Professional Nurse. Additionally, you should possess certifications in CPR, ACLS, and BCLS. Knowledge of OSHA, FDA, and HIP...