• Gender: Male
• Age: 38
• Designation: Sr. Engineer
• Highest Education Level: Diploma
• Preferred Country: India
• Notice Period: 30  Days
• Preferred Location: Osmanabad
• Work Experience: 13.8 Year(s)

Education

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

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.