4 Quality System Jobs

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Take ownership of QMS documentation, ensuring it's current, accurate, and accessible. Regulatory Compliance: Apply strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and EU Medical Device Regulation (EUMDR) to all quality processes. Design History Files (DHFs): Manage and maintain Design History Files, ensuring completeness and compliance throughout the product development lifecycle. CAPA Management: Lead and support Corrective and Preventive Actions (CAPAs), from initiation and investigation to implementation and verification of effectiveness. Audits: Facilitate and support internal and external audits (e.g., regulatory inspections, notified body audits), ensuring readiness and effective follow-up on findings. Supplier Quality: Oversee supplier qualification, monitoring, and quality agreements to ensure high standards across our supply chain. Training & Calibration: Manage and track quality-related training programs and ensure timely calibration of essential equipment. Cross-functional Collaboration: Partner with teams like Product Development to integrate quality requirements early in the design process and support overall quality improvements. Regulatory Submissions: Provide critical support for regulatory submissions, ensuring all necessary quality documentation is complete and accurate.

LOB Financial Services PREFERRED SECTOR/INDUSTRY Legal & Compliance DESIGNATION B2 Sr. Analyst QUALIFICATION CS. (Must) LL. B (preferred but not mandatory) JOB RESPONSIBILITIES The role of Sr. Analyst in Legal & Compliance shall encompass various tasks including, but not limited to, the following: Preparation of management committee meetings, board meetings and the GPs of Client funds Drafting of management committee and board meetings minutes and review of GP minutes including maintaining policies/minutes trackers/action logs in this respect Manage corporate and legal & compliance process Ensure quality assurance and checking for all the deliverables Ensure creation of training plans and manuals, quality manuals, SOPs, query log, escalation matrix, guidelines, checklist, etc. Manage team and accountable for QAs/QCs/Analyst work Oversee Implementation of the Quality system in the project Quickly and effectively train resources on process and client tools. Creating SOPs, guidelines, checklist, quality manuals, training manuals etc. Reports to Team lead DESIRED SKILLS & COMPETENCIE Candidate should have at least 3.5 6 yearsexperience in the legal/corporate department of a fiduciary or have worked in a law firm. Candidate should be willing and looking to consolidate and grow the skills and talents in the long term with a company that works in a dedicated team and results-based environment. Technical Skills Knowledge of regulatory and corporate environment for Irish/Luxembourg funds Understand key challenges General Counsels face in running corporate legal departments and functioning of law firms Engage with Clients, support decision making, delivery/governance related discussions Skills in planning, evaluation, research, analysis, training, problem solving and reporting Ability to facilitate and contribute to client sessions to define, illustrate and gain buy in to substantial departmental transformation via legal services Ability to perform email outreach to client Expert in analyzing legal and compliance issues Functional Skills Excellent written and oral communication in English Proficiency in using MS office Suite Experience in managing multiple/large teams Experience in Delivery and related governance Handling Client Escalations, Resourcing, People Management, Project Deliverables Implementing the Quality system in the project Ensuring appropriate use of methods, tools, and techniques in project Co-ordinating customer-related activities including acceptance of the deliverables Engage with Clients, support decision making, delivery/governance related discussions

Open Positions: Officer / Executive / Sr Executive Quality Assurance & Quality Control : Analytical Skill on HPLC, Electrophoresis, Microbiology, Document Review, IPQA, Quality Systems, GMP Compliance, QA-QMS Biosimilars Manufacturing: Downstream (Operation of Chromatography systems) & Upstream (Handling of Single use and Stainless-steel bioreactors) Experience: 2 to 10 years of relevant experience in Biopharmaceutical Qualification: B Sc / B. Pharm/B Tech / M Sc in Microbiology / Biotechnology / Chemistry/M. Pharm Date : 01st June 2025, Sunday Time : 08:30 AM to 06:00 PM (Registration will be closed by 12:00 PM) Venue : Hotel Pride , 5, University Rd, Narveer Tanaji Wadi, Shivajinagar, Pune, Maharashtra 411005, India Note: All positions are based out at Pune, Gotawade.

Should have proper knowledge in Personal Care Products, Should be able to do out of box thinking Lead a team of scientists to develop products in Personal care category Should have proper knowledge of NPD process. Required Candidate profile M.TEC in Cosmetic from leading Cosmetology College or M.Tec from ICT Mumbai Experience Should have 7-8 Years of experience in leading Indian MNC or MNC or 3rd Party Manufcturing, In Personal care