plastemartjobs.com Email: jobs@plastemart.com, hr@plastemart.com Download Date: 4/2/2025 5:54:58 PM ________________________________________________________________________________________ RefNo: CA - 30507 Gender: Male Age: 38 Designation: Sr. Engineer Highest Education Level: Diploma Preferred Location: Osmanabad Notice Period: 30 Days Education Details: Diploma in Pharmaceutical Regulatory Affairs Global institute of regulatory affairs , Pune. in 2016 B. Sc. from Dr. B.A.M.U. Aurangabad in 2011 H.S.C. from H.S.C. Board, Latur. in 2004 S.S.C. from S.S.C Board, Latur. in 2002 Skill Sets: ABOUT REGULATORY Basic knowledge of preparation of regulatory required documentation like CTD, product license renewal, FDA approve,etc CORE COMPETENCIES Self-confident, hardworking, flexible, patient. Proficient in MS Office ( MS-Word, MS-Excel, MS-PowerPoint ) SAP System Work Experience: 13.8 Work Experience Details: Sr. Engineer From -September 2022 to till date Comapny profile - manufacturing of disposable syringes and intravenous infusion kits. Job profile - In-process Quality Control Responsible for routine daily process activity. Issuing of line clearance at every step of batch manufacturing. Maintain control & follow the SOPs and cGMP rules and regulations in the work. Actively involved in qualification activities of Machines & equipment. Completion of in-process documentation of running batches, reviewing batch manufacturing records, batch packing records, logbooks, calibration records, etc. Ensuring that all QC tests are carried out on the line and in full. Experience in facing ISO-TUV, ISO-13485 audits, and internal audits. Preparing and Reviewing Validation documents. (Protocols, reports, batch records). Experience of preparation reports of RCA, CAPA, change control, deviation, incidence report, and market complaint investigation. Working in MNC culture and attending various cGMP training. Actively involved in calibration & validation activities of instruments & equipment. Experience of implementation quality management systems in the organization. Carrying out 5s, and kaizen activities for continuous improvements. Reported any identified critical compliance risks to senior management. Preparation of various training records as per training schedule. Participated in various training programs Internal as well as External. Experience in handling SAP and carrying out various SAP activities such as COA preparation, and batch release. Responsible for auditing medical device areas as part of internal audit. Implementation of continual improvements in devices aplicable areas. Reviews the compliance documents (Audit response / CAPA) and supports the team in taking an informed decision on approving the supplier/vendor/service providers. INJECTION MOULDING Daily shift starting meeting with operators to run the m/c as per plan, quality-related issues. Planning for mold changes as required & actively involved in the mold changing process. Daily DPR preparation Daily tracking the production achievement as per simulation target. Daily SAP work Monitoring the production process as per std cycle time. Attending the mold / m/c-related issues & taking corrective action Provided training to new joining operators about entry-exit The procedure, gowning - de gowning process, also molding-related SOPs. Provided training to operators about following the GDP, safety measures, and quality inspection. Contribution to defect control Check & find out defect generation RC then make required changes as a corrective action to arrest the defect generation. Sr. Executive (In process Quality Control) From June-2012 to September 2022 Company profile- manufacturing syringes & Needles, Dialyzers, Blood Tubing, Arterial Fistulas. Job profile- Responsible for routine daily in process activity. Issuing of line clearance at every step of batch manufacturing. Maintain control & follow the SOPs and cGMP rule and regulation in the work. Actively involved qualification activities of Machines & equipment?s. Completion of in-process documentation of running batches, reviewing batch manufacturing records, batch packing records, logbook, calibration records, etc. Ensuring that all QC tests are carried out on the line and in full. Experience of facing ISO-TUV, ISO-13485 audit, internal audits. Preparing and Reviewing of Validation documents. (Protocols, reports, batch records) and CAPA reports, deviations and preparing the investigation reports of the same. Working in MNC culture and attended various cGMP trainings. Actively involved in calibration & validation activities of instruments & equipment?s. Having knowledge of quality management systems i.e. document control, change control, deviation, incidence report and market complaint. Carrying out 5s, kaizen activities for continues improvements. Reported any identified critical compliance risks to senior management. Preparation of various training record as per training schedule. Participated in various training program Internal as well as External. Experience of handling SAP and carrying out various SAP activities such as COA preparation, batch release. Quality Control Officer From June - 2011 to May 2012. MAHIKA PACKAGING INDIA LTD. Job profile- Responsible for routine daily in process activity. Responsible for line clearance, first piece approval, batch records, ISO related documents. Preparing certificate of analysis ( COA) and pre-dispatch inspection ( PDI) for outgoing goods. Manage QA / QC inspector. Train new inspectors and conduct recurrent training as required. Future Goals: My knowledge, skill and attitude towards the organization will always be a high point of my work. I will serve for the success of an organization with the best of my abilities based on my past experience. ________________________________________________________________________________________