679 Fda Jobs - Page 11

Roles and Responsibility Develop high-quality regulatory documents, including clinical trial applications, marketing authorizations, and periodic safety update reports. Collaborate with cross-functional teams, including regulatory, clinical, and product development, to ensure compliance with regulatory requirements. Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and adherence to company standards. Stay up-to-date with changing regulatory requirements and industry trends to improve document quality and compliance. Provide training and guidance to junior writers on regulatory affairs and medical writing best practices. Participate in the development of new r...

Role & responsibilities -Handling of Pharma Instruments i.e. HPLC, GC, UV, KF, IR, etc. -SOP Preparation. -Analytical documents preparation. -Wet analysis to be performed. Preferred candidate profile -Having experience in Pharma company only. -Having experience to face regulatory & customer audits. -Having knowledge of GLP & GMP importance.

Roles and Responsibility Manage and oversee the collection, review, and reporting of clinical trial data. Ensure compliance with regulatory requirements, such as GCP and FDA guidelines. Develop and implement effective data management plans and procedures. Collaborate with cross-functional teams, including clinical operations and statistical analysis. Conduct quality control checks on data accuracy and completeness. Provide training and support to site staff on data management best practices. Job Requirements Strong knowledge of clinical study protocols, informed consent forms, and case report forms. Experience with data management systems, such as Oracle or SQL. Excellent analytical and prob...

Number of requirements 1 / Level 3 rd Experience: 6 to 7 Years Job Overview: As a SAP CRM Consultant specializing in Application Support Management, the primary responsibility will be to provide ongoing application support, maintenance, and request fulfillment enhancements for SAP CRM systems. The consultant would have to work closely with business users to understand their needs and ensure that the CRM application remains reliable, secure, and aligned with GB ( Business Unit) goals. Qualifications: Bachelor's degree in a relevant field, such as Computer Science, Information Technology, or Business. Proven experience in SAP CRM On Premise application support and management. ( 6-7 years) Stro...

Job Title: Manager / Sr. Manager Sales & Marketing (APIs) Location: Vashi, Navi Mumbai Department: Sales & Marketing Reporting To: Marketing Head About Us Calyx Chemicals & Pharmaceuticals Ltd. is a leading manufacturer and supplier of Active Pharmaceutical Ingredients (APIs). With a strong global presence and focus on innovation, we are committed to delivering high-quality pharmaceutical solutions while ensuring compliance with international standards. Key Responsibilities Develop and execute strategic sales & marketing plans to drive revenue and business growth. Identify new business opportunities in domestic & international API markets. Monitor market trends, competitor activity, and regu...

Define and implement reliability strategies and frameworks for software systems. Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. Lead risk management activities including DFMEA, hazard analysis, and traceability. Design and maintain post-market monitoring and alerting solutions to proactively address issues. Conduct root cause analysis and drive effective CAPA implementation. Develop tools and automation for reliability testing and validation. Ensure system availability through redundancy, failover, and recovery strategies. Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. Mentor team...

As a global leader in assurance, tax, transaction, and advisory services, EY is dedicated to hiring and nurturing passionate individuals like you in an effort to contribute towards creating a better working world. Our culture is rooted in the belief that every individual deserves the training, opportunities, and creative freedom essential for growth. We are not solely interested in your current capabilities but in the potential of who you can become. Your career is yours to shape, with limitless possibilities awaiting you. Throughout your journey with us, we are committed to providing you with inspiring and fulfilling experiences that will aid you in evolving into the best version of your pr...

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide y...

Manufacturing operations, ensuring GMP compliance and safety. Monitor Manufacturing/production, maintain batch records and SOPs, assist with audits, and drive process improvements to enhance efficiency, reduce costs, and improve product quality.

Note to Hiring Manager: In support of BNP Paribas APAC's Diversity Commitment, Hiring Managers are to consider at least 1 Asia Pacific national, 1 male and 1 female candidate for the position to be filled. Position Purpose Facilitating transaction processing of instructions received from Client to ensure all settlement of trades in Global markets. Providing round the clock service to cover client queries across ASIA, EMEA and US regions. Reconciling client positions to match with the market positions. Being a team player and a manager to achieve team co-ordination, adhere to BNP policies and follow the agreed timelines to avoid any breach in SLA. Responsibilities Job summary Roles & Responsi...

Multiple requirements as Analyst for HPLC, GC and ICP at middle and senior level. Experience from public testing lab will be an added advantage. Preference will be given to immediate joiners or who are ready to join in short notice period. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) Walk-in interview 22-Sept to 26-Sept 9.30am to 5pm on 27-Sept-25(Saturday) from 9.30am to 3pm

Operations Head Job description: About NowZone Life: NowZone Life is a forward-thinking medical device organization dedicated to enhancing patient care and improving health outcomes. We develop, manufacture, and distribute innovative medical solutions that empower individuals and healthcare professionals. Our commitment to quality, compliance, and innovation is at the heart of everything we do. Join us in our mission to make a tangible difference in the lives of patients worldwide. Position Overview: We are seeking a highly skilled and motivated Operations Manager to oversee our end-to-end production and manufacturing processes. This critical leadership role is responsible for ensuring the e...

As a Senior Validation Engineer at ValGenesis, you will play a crucial role in ensuring compliance and quality of the innovative software solutions tailored for the life sciences sector. Your responsibilities will include: - Working hands-on in an individual capacity to deliver project milestones. - Collaborating with Product, Engineering, and Testing teams to understand product functions. - Reviewing various product requirements such as Epics, User stories, and User Requirements. - Authoring test cases in OQ and PQ protocols in alignment with requirements and QMS guidelines. - Generating realistic test cases and test data based on customer usage scenarios. - Executing test cases, reporting ...

As a QC Microbiologist I, you will be responsible for performing various microbiological testing activities under minimal supervision. This includes water testing, environmental monitoring, media preparation, growth promotion of media, raw material testing, finished product testing, stability testing, antibiotic assay testing, gram staining, microbial enumeration suitability testing, antimicrobial effectiveness testing, and other required microbial testing. Your role requires maintaining quality and efficiency in all tasks performed to ensure accurate results. Your responsibilities will include routine water testing, media preparation, growth promotion of media, and environmental monitoring....

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

As an experienced developer specializing in Oracle's JD Edwards Enterprise One management system, your role will involve developing, customizing, and maintaining applications to meet the unique requirements of each client. Your responsibilities will include: - Participating in implementations and migrations of Oracle's JD Edwards ERP software - Performing technical analysis to provide solutions, estimate timelines, and evaluate implications - Developing customized applications, localizations, and user interfaces - Conducting tests for applications and documenting design, programming, and procedures - Providing maintenance and support for applications, including incident resolution and monito...

Job Title Norm Compliance Officer Job Description Norm Compliance Officer The purpose of this position is to handle end-to-end Norm Compliance activities for Diagnostic X-ray systems as part of the Research and Development team, with all relevant mandatory international and national regulations. Your role: Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations. Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual sy...

Manufacturing Systems & Compliance Support manufacturing and laboratory systems (e.g., LIMS, MES, SCADA, PLCs, BAS, and ERP). Ensure IT systems comply with GxP regulations and 21 CFR Part 11. Support and maintain including documentation as per SOPs Required Candidate profile IT experience in a manufacturing environment (pharma preferred). Familiarity with GMP, GAMP5, and regulatory units (FDA, EMA). Supporting validated systems and documentation for audits/inspections. Perks and benefits Accommodation & Transportation

The role involves preparing and reviewing regulatory documents, ensuring compliance with national and international guidelines, and supporting product registration processes. Required Candidate profile Looking for a Regulatory Affairs Officer with 2-3 years of experience in the Pharma/API sector. Candidates should have strong MS Office skills and good communication abilities.

As a Consultant, you will be a key resource on client engagement. Be up to date with key technical and functional skills, and industry trends Skills and attributes for success Experience in Transfer Pricing and/or direct tax domain Skills and attributes To qualify for the role you must have Qualification Chartetred Accountant/ Postgraduate in Economics / MBA Finance Experience Prior experience/insight into Transfer Pricing Regulations (India and OECD) and/or India Income Tax provisions are desirable.

About The Role : Job TitleRegulatory Control Analyst Corporate TitleAssociate LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collecti...

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Pr...

About The Role : Job TitleRegulatory Control Analyst, NCT LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as ...

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals...