SHARAD BANSODE

Mob. No: 088********

E-Mail: adkpue@r.postjobfree.com

Senior level position in API Production with a growth-oriented organisation of repute.

PROFESSIONAL OVERVIEW

A detail oriented and result focused professional experience in directing and optimizing Production to improve qualitative production output in API Industry.

Currently working with Ind-Swift Laboratories Ltd, Chandigarh from July 2017..

Ind-Swift Laboratories Ltd site having total 25 facilities along with regulatory certifications approved by USFDA, MHRA, TGA, PMDA KFDA, JFDA etc.

Currently handling of two no’s of API Facilities.

Total manpower strength is 56 No’s including both plants.

Handling of approx. 35 MT capacity monthly, including intermediates and API’s.

Proficient in performing an integral role in plant's operational success and profitability, knowledge of 40 + API and intermediate products.

Efficient in managing team as well as assisting them to reach the designated objectives set within the organisation and team to fulfil Knowledge in the field of API manufacturing Plants.

Knowledge of debottlenecking and capacity enhancement work.

Knowledge of QAMS software and Trackwise software and SAP PP module for QMS activities.

Knowledge of eDMS and DAS system software’s..

Handling of DCS system D.C.S. (SIEMENS PCS-7). SCADA & P.L.C. System.

Expertise in complete Production procedure of hormone/steroid API’s and non-hormonal API’s.

Inspections Handled

Good experience over the audits done by External Agencies & Organizations.

Handling of audits like USFDA, MHRA, WHO, TGA, PMDA etc

Customers Audits, Internal Audits, Safety Audits etc.

ACADEMIA.

M.Sc. (Organic Chemistry) 55.41%

Dr. B.A.M. University Aurangabad.

MBA (Operation Management) 58 %

IGNOU Delhi

Advance Diploma in Industrial Safety 64.5 %

From MSBTE Mumbai

PROFICIENCY FORTE

Production Planning & Control

Planning the production and completion of batch productions and validation activities within the time lines; working in pilot plant and execution of pre-validation and validation batches under R& D professionals also providing work direction to manufacturing personnel and defining priorities on a day-to-day operational basis.

Ensuring effective resource planning for optimizing man & equipment utilization, reducing wastes for enhancing productivity and profitability.

Handling of more than 40 products including general API and steroids/hormones etc.

Expertise in complete Production procedure of hormone/steroid API’s and General API’s.

Maintenance Coordination

Resolving technical, operational, quality issues and minimization of non-compliance issues in manufacturing.

Effectively interfacing with people at all levels, managing healthy work environment and inculcating bonded teamwork with high work ethics.

Quality Compliance

Participating in quality & process improvement initiatives along with technical services, R&D, QC, QA, process Engineering Departments, etc;

Review, preparation and Investigations of OOS, OOT, deviations etc.

Review, initiation of change controls, amendments related to process and modification, etc.

Review of cleaning validation and process validation related protocols and reports.

Guiding and monitoring the work to the plant personnel on Production/Process related topics.

Reviewing and Preparing the Standard Operating Procedures (SOPs), related to QC, Maintenance, EHS and production.

Preparation of monthly and quarterly training calendar for manufacturing department.

Training on Quality system and cGMP EHS, related documents all manufacturing department personnel.

KEY DELIVERABLES

Conducting regular batches and its critical checks, raw materials, safety parameters of Intermediate as well as & finished products.

Handling of documents like change control, deviations, OOS, OOT and CAPA in QAMS and Trackwise software.

Investigations of OOS and OOT and preparation CAPA.

Knowledge of D.C.S. (SIEMENS PCS-7). SCADA & P.L.C. System.

Operation of DCS through in HMI’s .(Human machine interface)

Handling of SCADA system, preparation of temp. Graph in equipment wise and monitor the control the operation through DCS.

Control of process parameters using DCS system.

Handling of Data acquisition system for temperature and humidity control in controlled area.

Handling manpower, resolving issues, team building, training and development of Operating personnel and subordinates.

Provided and execute suggestions for improvement of production, quality, cost, and operation safety.

Preparation and review of BMR, ECR and SOPs and other cGMP related documents.

Actively involved in weekly/monthly production planning & given suggestions time to time for system improvement.

Managing the approval of quality related documents such as SOPs, BPRs, Masters Documents and APQR.

Handling change control, new Project, capacity enhancement and modification, etc.

Maintaining cGMP, and other system oriented records; monitoring the approval of RM / PM.

After completion of validation batches preparation of campaign report as well as complete Quality Risk Management (Risk Assessment) of Product/projects.

Knowledge of Effective utilization of all available resources in API plants.

Work on isolators (make: - Bectochem) used for RM dispensing, charging cleaning etc. distillation in Rota vapour, adsorption column, RBF, ANFD, and contraceptive product handled by using PAPR.

SAP PP module knowledge: BOM and recipe, material movements etc.

High temperature & high-pressure reactions handled (at 5 to 50 kg pressure.) reactors plant Level Also. (E.g. Ammonolysis, Hydrogenations, etc.).

Handling of high potent drug product like Levonorgestrel, Desogestrel, Drospirenone, ethinylestradiol, norethindrone, etc

Knowledge and experience in isolation, separation, purification techniques and study of purity and impurity profile.

Handling of contraceptive products like Drospirenone, Levonorgestrel, Desogestrel, Norethindrone, Norethindrone Acetate, Testosterone, its intermediates under controlled area temp, and environment.

An effective communicator with strong relationship management, leadership, analytical and coordination skills in interacting with people across organisational levels for ensuring smooth task execution.

Knowledge of sterile plant, operations handled under controlled environment.

References

1.Dr. Vinay Nayak. (Independent Director) Aarti industries Ltd Mob no. 937-***-****

2. Mr. Bhagwat Patil. (Sr. GM Aurobindo Pharma Hyderabad) Mob. No. 961-***-****

EMPLOYMENT SCAN

Lupin Ltd, Indore (M.P)

Designation: Executive Production (Duration: Dec. 2012 to July- 2017)

Ranbaxy Laboratories Ltd. Dewas (M.P)

Designation: Sr. officer Production (Duration: Sept. 2010 to Dec. 2012)

Watson Pharma Pvt. Ltd, Ambernath (Mumbai)

Designation: Sr. Officer Production (Duration: Aug. 2009 to Sept. 2010)

Lupin Ltd, Tarapur Mumbai

Designation: Sr. Officer Production (Duration: Nov 2008 to Aug. 2009)

Orchid Chemicals and Pharmaceuticals Ltd, Aurangabad.

Designation: Production Officer (Duration: May 2006 to Nov. 2008)

IT FORTE

MS-Office,

SAP, PP module.

QAMS software,

Trackwise Software

DAS, eDMS, software

Training software: LMS, SABA

PERSONAL INFORMATION

Date of Birth : 25tH AUG 1981.

Address : Gulmohar City Ext, Derabassi,Dist., Mohali Punjab. 140507.

Mob. 700*******

Language : English, Hindi, and Marathi.

Passport no: H922890

Date: Sharad Bansode

CORE COMPETENCIES

Quality & Productivity Improvement

New Product Materials Coordination

Policy / Procedure Development

Documentation and Reporting

Process Improvements

Critical Problem Analysis/Resolution

Team Management

Regular Reporting & Communications

Operations Management in API Production

Contact this candidate