212 Cmc Jobs - Page 9

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :4 to 6 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :5 to 8 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The candidate should have adequate knowledge in regulatory affairs (Injectable or Ophthalmic formulations) for US market. He/ She should have 3 - 5 years of experience with B. Pharm./ M. Pharm./ M. Sc. as a educational qualification. Candidate should possess excellent verbal and communicational skills.

Job Context: To support MIBG I-131 clinical programs and other JDI innovative products in the pipeline, The Regulatory Specialist will be reporting to the director of Regulatory Affairs and support the development of regulatory strategies related to JDI clinical programs, marketing applications in US and Canada and post-marketing activities. Challenges: 3. SCOPE and SIZE OF THE ROLE (Please indicate key metrics defining the size and scope of the role) Revenue / Operating Budget As per JDI RA budget plans Geographical Responsibilities (Global / International / Country / Area with in Country Will work with the team in Canada and based out of India Area of Impact (Dept. Location / Function or Business / Organization) Regulatory Affairs 4. KEY ACCOUNTABILITIES: ;;;;;;;;;;;;;Accountabilities ;;;;;;;;;;;;;;;;;;;;;;;;;;;Scope of work Regulatory Support Support regulatory due diligence activities pertaining product in-licensing or acquisition (product in clinical development or approved products). Re-evaluate the regulatory strategies following major changes including but not limited formulation, clinical protocol and marketing changes. Participate actively to meetings with regulatory agencies (pre-submission phase, NDA/NDS review phase, post-approval phases) Prepare, review and submit USFDA Investigational New Drug Application (IND) and Health Canada Clinical Trial application (CTA) filings to include but not limited to: new protocols applications, clinical protocol amendments, informed consent forms, clinical summary reports, regulatory correspondences, deviations, safety reports, cost recovery applications, exemptions, CMC amendments. 5. KEY INTERFACES External Interfaces Internal Interfaces Regulatory Agencies Clinical sites, Quality, marketing, clinical, technical services and R and D departments 6. EDUCATION and EXPERIENCE Indicate the education level, previous experience, specific knowledge, skills and abilities required to meet minimum requirements for this Job.. Education Qualification(Highest ) with Target Institute(s) Bachelor's degree in biology, biochemistry, or other life science Desired Certifications : A minimum of 5 years of related experience. Experience Range : 10 - 12 years No. of years post Highest Qualification : 8 years Desirable experience : 10 to 12 Years of Industrial Experience 7. SKILLS REQUIRED: ;;; Skills Description Proficiency Level (General Awareness; Working Knowledge; Functional Expert, Mastery ) Functional Skills Must be detail-oriented with well-developed organizational and analytical skills Functional Expert Behavioral Skills Must be self-motivated, capable of managing multiple projects in a fast-paced environment. General Awareness : Knows the fundamental or general understanding of concepts. Working Knowledge : Has broad job knowledge; knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concept in day to day practices. Functional Expert: Candidate is certified functional expert with strong knowledge on concepts. Mastery: Candidate is subject matter expert and has command over the subject/ concepts.

Skill requirement: Primary Skill --> Business Object 4.2 (Developer and Administrator), Web Intelligence / Crystal Reports, Universe design, CMC, CMS and Oracle PL/SQL Secondary Skill --> Windows, Unix scripts, Agile methodology Experience 6 to 9 years JD: To participate in report server configuration / upgrade and other SDLC activitiesincluding testing , deployment and support To be able to write new BO reports or modify existing BO report and also work along with other developers To manage the testing team for unit testing, system testing, integrated testing, UAT etc., To write the technical specification, functional specification, test plans and test scripts To coordinate with other team like Business solution team, source management team, infrastructure support, data centre, production support and others To support production issues and join the incident resolution team during system break down incidents The required skills: Must have Should have been a programmer in BO / Crystal reports and have participated in development life cycle Must have worked on in BO universe and other BO tools Must have created and configured reports Nice to have Exposure to Banking business and Oracle Development experience in .NET or Java Development experience in Oracle - PL/SQL Exposure or work experience in MQ Knowledge of Unix shell scripting Knowledge of windows server management Soft Skills must have Should have good communication Should be a team player and exposure to people management skills Minimum 6+ years of experience

Lead the preparation, review, and submission of new regulatory dossiers for Solid Oral Dosage Forms (SODF), Injectables, and/or Ophthalmic products to regulated markets. Lifecycle,Labelling Management, Stakeholder,Team Leadership,Process Improvement

Role & responsibilities : Install configure and upgrade SAP BO environments BI 4x. Manage BO servers services and clusters including CMS FRS and Web Intelligence. Monitor system performance and availability implement tuning and optimization. Administer user access roles and security policies using CMC and CCM. Develop and maintain Universes using IDTUDT. Schedule and manage reports and dashboards WebI Crystal Reports. Troubleshoot and resolve issues related to BO tools and reports. Implement and manage auditing logging and alerting mechanisms. Collaborate with developers analysts and business users to support reporting needs. Perform backup and recovery of BO content and configurations. Document system configurations procedures and best practices. Qualifications: Bachelors degree in Computer Science Information Systems or related field. Required Skills 5-8 years of experience in SAP BO administration. Strong knowledge of SAP BO architecture and components WebI Crystal Reports IDT UDT CMC CCM. Experience with SAP integration SAP BW ECC HANA. Proficiency in SQL and scripting UnixLinux shell PowerShell. Familiarity with Single SignOn SSO LDAP and Active Directory integration. Excellent problemsolving and communication skills. Preferred candidate profile: SAP Certified Application Associate SAP BusinessObjects. Experience with BI tools like Tableau Power BI or QlikView. Knowledge of data warehousing and ETL processes .

Designation Field Service Engineer Department Service Location Delhi NCR, Pune , Raipur/Bhopal Product Portfolio IVD (In-Vitro Diagnostics) Business Importance of the Role: This role owns delivering service & service business results as per Operational Metrics defined below & meets the operating Business Plan of Genworks. Manages high level of Customer satisfaction through Service Excellence at assigned customer accounts/IB by driving various Operations parameters as per target. Also drive Commercial excellence through AMCs, CMCs, Part Sales, Accessories & Consumable Business time to time. Over a period of time becomes the Customer success leader & be the Point of contact by building strong relationship between Genworks & respective OEM. Key Responsibilities to Deliver (Daily, Weekly, Monthly, Quarterly, Annual): Timely installation, Troubleshooting and Calibration Pre-installation demos, checks and user maintenance training for instruments including primary level of application issues and standardisation handling. Troubleshoot Instrument related issues (break fix issues). Strive for customer success through solutions-based growth approach.

Job Summary We are looking for an experienced SAP BO Developer to design, develop, and support Business Intelligence solutions using the SAP BusinessObjects suite. The ideal candidate will have hands-on experience in BO reporting tools, strong SQL/data modeling skills, and the ability to collaborate with business and technical teams to translate requirements into insightful and actionable reports. Key Responsibilities Design, develop, and deploy reports, dashboards, and universes using SAP BO tools (Web Intelligence, Crystal Reports, IDT/UDT, BO Dashboards). Gather and analyze reporting requirements from business stakeholders. Build and maintain semantic layers using Universe Design Tool (UDT) or Information Design Tool (IDT). Optimize BO reports and universes for performance and scalability. Work with SAP BW/HANA or other data sources to fetch and model data as needed. Schedule and manage BO jobs using Central Management Console (CMC). Conduct unit testing and support user acceptance testing (UAT). Troubleshoot issues and perform root cause analysis for reporting and performance problems. Document technical specifications and maintain support documentation. Required Skills 4 to 8 years of experience with SAP BO tools: Web Intelligence, Crystal Reports, IDT/UDT, Dashboards, Analysis for Office. Strong SQL and data analysis skills. Experience with SAP BW and/or SAP HANA as a data source. Good understanding of data warehousing concepts and ETL processes. Proficiency in performance tuning of reports and universes. Familiarity with user security setup and report distribution in BO environment. Experience with BO administration tasks like user management, folder security, and job scheduling in CMC. Ability to work independently and manage multiple tasks in a fast-paced environment. Excellent problem-solving and communication skills. Travel Requirement: Should have a valid passport to travel to client office if required. Should be ready to work Onsite (Middle East - Dubai / Riyadh) as per the need of the organization

Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Support with VDC strategy implementation and optimization. Comply with and support the maintenance of internal procedures. Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Handling of M3 databases Compilation/handling of wToCs for renewals/variations Drafting of eAFs and country information letters for dispatch packages Communication with local affiliates regarding local requirements Change assessments according to EU variation guideline CMC background preferred, IT affinity, very detail oriented, excellent communication skills Maintain knowledge and understanding of SOPs and current regulatory guidelines as applicable.

Job Details Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communication with clients and Health Authorities. Support with scientific advice procedures and representation of clients with health authorities. Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise. Support with VDC strategy implementation and optimization. Comply with, maintain and contribute to optimizing internal processes. Support with VDC led commercial, marketing and business development activities including proposal input. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Handling of M3 databases Compilation/handling of wToCs for renewals/variations Drafting of eAFs and country information letters for dispatch packages Communication with local affiliates regarding local requirements Change assessments according to EU variation guideline CMC background preferred, IT affinity, very detail oriented, excellent communication skills Maintain knowledge and understanding of SOPs and current regulatory guidelines as applicable.