2 Soltraqs Jobs

JOB DESCRIPTION: Followings will be the Core Job responsibilities of the position holder: 1. Ensure the compliance to laid standards of the good manufacturing practices. 2. Organizing the job responsibilities to the technicians as per daily plan and execute the defined targets as per standard outputs. 3. To ensure maintenance of Production Area and Equipments in the state of cleanliness as per the SOPs at all points of time. 4. To carry out routine documentation as per Regulatory Requirements and to complete BMR timely with all respects. 5. Continuous monitoring and improving the production output on daily basis and control on absenteeism of Technicians. 6. Continuous monitoring of In-process controls in production areas. 7. To fill and maintain the BMR online. 8. To maintain /fill the formats and other related documents and the to provide the training to the technicians. 9. Coordination with production Planning department for process order and Batch Record document with QA. 10. Checking of dispensed input materials against process orders. 11. Co-ordination for installation and Qualification of Production equipment. 12. To exercise effective control over the environmental conditions in Manufacturing and other related activities, which may adversely affect the product quality. 13. Compliance to specifications and Validated methods 14. To co-ordinate for calibration / preventive maintenance for all production equipments and instruments with engineering / QA / QC & outside agencies. 15. To work within the specified working hours. 16. Raising requisition for the requirements of Consumables related to production activities. 17. Handling of online systems and software such as SolTRAQs, Isotrain, Darius. 18. Preparation of Standard Operating Procedures, for related equipment's and procedures. 19. Training and evaluation of the Production Technicians for their qualification to specific task or to operate specific equipment. 20. Ensure compliance of SAP activities related to updation of BOM, creation of new item codes and regularizes the SAP entries. In absence of the position holder, the sub-ordinate Executive/ Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Manufacturing DIVISION: EPD Established Pharma LOCATION: India Village Mauza : Baddi ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

JOB DESCRIPTION: Primary Job Function: To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products. Ensure timely submissions and approvals for all regulatory filings. Evaluate technical and scientific data for regulatory submissions. Liaise with health authorities for inspections, clarifications, and approvals. Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs. Product & Business Support Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution. Provide regulatory support for internalization and externalization of products. To provide site CMC documents to international business team to support export registration. Documentation & Quality Oversight Maintain and update regulatory databases, trackers, licenses, and approvals. Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications. Evaluate and approve site change controls and Change Request evaluation forms. Provide working standards/specifications and CoAs to regulatory authorities and internal teams. Tender Certificates To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business. Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority. Governance, SOPs & Training Support the preparation, revision, and implementation of Regulatory SOPs and work instructions. Deliver training on GMP, regulatory updates, and SOPs at the site level. Approve SCNs from Corporate QA and review reports from regulatory authorities. Additional Responsibilities Complete assigned trainings on time Perform other duties as assigned by the Regulatory Affairs leadership. Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations. Position Accountability/Scope: . Responsible for all regulatory activities for the manufacturing site mainly LL sites. . Ensures site compliance with applicable national regulations and Abbott standards. Supports business continuity through proactive regulatory planning and execution. Minimum Education: B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline. Minimum Experience/Training Required: Manager: Minimum 08 - 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable. Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: EPD Established Pharma LOCATION: India Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)