Role & responsibilities: To enhance the quality system by imparting cGMP knowledge and updating regulatory requirements to the sites. To provide new regulatory guidance and technical documents to the site. To maintain a quality intelligence database and inform the concerned site about current regulatory requirements, updates and changes as and when required. To prepare corporate quality policy, standard practices, and corporate directives for system harmonization across all sites. To evaluate and ensure continual improvement of the quality management system. To verify policy implementation at the site and extend the identified gaps to the site for compliance. To review and evaluate regulatory guidelines, other company 483s, warning letters and inspection reports as per current regulatory requirements and extend identified gaps into quality intelligence portal to sites for compliance. To inform the Zydus family about new quality issues, current regulatory inspection trends, forecasts and best possible practices. To impart policy training to the site as and when required. To initiate corporate change controls for preparation and revision of quality policies. To review, verify and monitor the implementation of extended Global CAPA, Policy implementation observations and quality intelligence observations at sites. To perform any other activity assigned by HOD, as and when required. Preferred candidate profile: 2 Vacancies: one is for QA OSD background and second is for QA Injectable background. Candidate must be from pharma QA (OSD or Injectable) background. Must have Good communication skill, drafting skill and interpersonal skills. Must ready to travel to site location for inspections and audit. Must be ready to work at Ahmedabad location.
Job Responsibilities: Overall Responsibilities: 1. Compiling all the relevant information necessary to prepare best regulatory dossier (M1 to M5) for registration of a new vaccine or a license update in all concerned row countries including WHO Prequalification. 2. Developing and maintaining the Regulatory Dossier Module 1 to Module 5 keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions. 3. Participating and performing change control assessment (CCRs) of any necessary changes and implementation plan with a global view for the impacted product(s). Filing of relevant Post approval Change (Variation). Primary Responsibilities: Marketing Authorization Applications (Preparation of dossiers for registration in ROW countries in CTD/ACTD/eCTD) Application for Post Approval Change(s)/Renewal Maintenance of Documentation Data base available with vaccine IRA. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. Review of Pack Profiles. Review of Artworks (Labels and Package Insert). Preparation / compilation of technical documents related to tenders / queries. Arranging Samples required for registration Secondary Responsibilities: To ensure continuous improvement in the quality of registration documents, internal systems and processes. Responsible for notification to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority Vaccine Regulatory Intelligence, Sharing vaccine regulatory updates. Profile Preference: Masters degree in Microbiology/ Biotechnology/Pharma Experience in R&D or Quality Assurance or Quality Control of vaccine & Biologicals shall be considered Proficient in MS Word, Excel, PDF, PowerPoint Experience in preparation of regulatory responses. Strong written and verbal communication skill Strong organization skills Strong Regulatory knowledge and demonstrated application shall be very helpful Strong background in biologics/vaccine/drug development, manufacturing, or testing Demonstrated ability to work successfully on global project teams.
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