Aalok Marathe Email & Phone Number

Dublin, County Dublin, Ireland

County Dublin, Ireland

Dublin, County Dublin, Ireland

As a Quality Systems Coordinator, I am responsible for verifying compliance with the QMS systems, protocols, and procedures. I offer support during the coordination and facilitation of third-party audits. I collate insightful performance reports on quality compliance, for management review. In addition, I monitor the compliance of the QMS to proactively identify shortcomings and generate innovative solutions for improvement.- Responsible for maintaining and distributing the updated controlled copies on the floor to provide up-to-date manufacturing guidelines.- Point of contact to provide GDP and GMP training to new starters in the organization. - Responsible for reviewing and approving of Work Instructions (WI), Standard Operating Procedures (SOP), Validation Documents.- A thorough and working understanding of Quality Systems such as ISO 13485, ISO 14971, 21 CFR part 820, Eudralex Vol 4.

Dublin, Ireland

In this position, I inspected the quality of manufactured medical devices to verify alignment with the dimensional and visual specifications. I generated batch records and samples for auditing purposes, as well as implemented innovative strategies aimed at the resolution of deficiencies. I supervised a three-member team of Assembly Operators throughout duty execution and continually monitored their performance. In addition, I performed root cause analyses and applied fault-finding techniques to rectify errors. Furthermore, I executed site acceptance tests and validation for moulding machines against their specifications.~ Serving as the Health and Safety Associate, tasked with conducting machine safety checks and risk assessments to validate calibrations, as well as prevent production delays.~ Partnering with two Process Technicians to investigate errors, test samples, eliminate defects, and produce safety reports.~ Avoiding the contamination of products as a result of continually administering updates to ISO 9001:2000/ 14001/ 13845 documentation, as well as through strict enforcement of environmental and quality standards.

County Dublin, Ireland

Maharashtra, India

I worked as a volunteer for the project "Speak out".

Mumbai Area, India

As a Project Intern, I supported the integration of manufacturing equipment within a small warehouse. I conducted visual inspections to validate the packaging areas, verify alignment with the GMP guidelines, and deliver strategic consultancy pertaining to the calibration settings that match the requirements. Drafted standard operating procedures related to cleaning, packaging, staffing, and training. Additionally, I verified strict alignment with the environmental standards.A notable outcome from this role was:- Understanding of importance of GMP, GDP, GLP in a controlled environment- Creating and preparing SOP's with compliance to latest guidelines.

Msc In Pharmaceutical Business And Technology, Pharmaceutical Sciences

Bsc, Bioinformatics

Hsc, Science

Ssc