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5.0 - 9.0 years
0 Lacs
ahmedabad, gujarat
On-site
As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions on regulatory topics, and ensuring the quality and compliance of critical documents/submissions related to DMFs, ANDAs/S, and Amendments. Furthermore, you will be responsible for formulating RA Strategy of ANDA/DMF/DS for ongoing projects, ensuring timely submissions to regulatory authorities, leading the Global DMF Team/Process, and coordinating global regulatory efforts for DMF/API between Raks, Amneal India & Amneal USA teams. Innovation and continuous improvement are key aspects of your responsibilities, as you will be developing RA tools, coordinating with SSSM team/vendors for document requirements, resolving DMF critical issues, and supporting audits with necessary regulatory information. Your role will also involve evaluating critical change notifications, supporting launch activities, handling team management and development, project distribution, resource planning, and candidate selection processes. Additionally, you will conduct yearly performance appraisals, approve team attendance, and ensure compliance with regulatory submissions. The ideal candidate for this role should have an M. Pharm / M. Sc. qualification and possess strong leadership skills, regulatory knowledge, and the ability to drive regulatory compliance across various projects and teams effectively.,
Posted 2 days ago
10.0 - 14.0 years
8 - 15 Lacs
Bengaluru
Work from Office
Preferred candidate profile M.Sc Organic Chemistry with 2-3 yrs. experience in Process /synthetic chemistry & 6-7 yrs. experience in API QA [ review of process development documents including KSM/KRM identification, specification proposal and stability reports. Role & responsibilities Prepare and Review Standard Operating Procedures and Guidelines for DQA. Review documents with respect to drug substance such as protocols, SOPs, test methods, data, BMR, BPR, ROAs, COAs and reports through collaboration with PRD, ARD and QC scientists, to achieve the highest quality from technical and compliance perspectives. Review process development documents including KSM/KRM identification, specification proposal, analytical method development/validation reports, stability protocols & reports, and safety studies. Responsible for investigations against laboratory Incidents, OOS, OOT encountered with aim of root cause identification and CAPA implementation. Responsible for assessing the impact, review and closure of Change control requests and Deviations. Responsible for CAPA implementations, verification of and effectiveness. Responsible for maintaining the Quality Metrics and preparation of Quality Metrics. Plan, execute internal audits, external audits and communicate audit schedules, outcomes to audit stakeholders ensuring CAPA appropriateness for closure, audit trending for continual quality improvement. Review and approval of Stability management activities of Drug substance and Drug products such as Stability Protocol, data and stability summary report. * Note : We are not looking for IPQA, CQA/Analytical QA personnel. Candidates with experience in review of process development documents including KM, KRM identification , specification proposals and API QA experience are required.
Posted 1 month ago
4 - 9 years
0 - 0 Lacs
Bengaluru
Work from Office
Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of change controls, deviations, Investigation and CAPAs and closure of the same. Tracking of QMS activities and coordinating with cross functional departments to complete the QMS activities like investigation for OOS, complaints, deviations. Identification, preparation and implementation of SOP’s. This position will prepare SOPs related to the machines which are undergoing commissioning and procedures which are proposed to implement in Drug product area. Preparation and review of URS, CLIA, SLIA, QRM, IQ and OQ documents. Involvement in the qualification activities of equipment and area in drug product area People: Champion the OneSource Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan. Preparation and execution of training modules on SOP’s in the department. Preparation and execution of QMS documents in the department. Preparation and execution of training modules on QMS and safety SOP’s in the department. Preparation and execution of training on soft skills to develop the team. Finance: Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product, process or site.
Posted 2 months ago
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