Permanent Address:

Flat No. C**, Neha Galaxy, Gut No.91 Deolai Road Beed By-Pass,

Aurangabad (Pin Code: 431002)

Maharashtra.

Mr. Gokul Ramdas Pawar

Contact No.: 898-***-**** / 942-***-****

E-mail ID: adney0@r.postjobfree.com

Career Summary:

Self motivated and result oriented Chemical Engineer with 15 years of experience in manufacturing of various APIs (Active Pharmaceutical Ingredients) in different organizations with expertise in demonstrating analytical thinking and problem solving skills.

Key Strength:

•knowledge of Systems Applications, Products in Data Processing (SAP)

•.Indent management along with daily consumables & other necessary stocks of plant related to CAPEX.

•Handling of QMS related activity like deviation, change control in Trackwise system.

•Preparation of necessary documents like PVP, PVR, SOP, MPCR, Risk assessment report.

•Preparation of investigation report of OOS & OOT.

•Online review of BPCR and respective usage log book

•Planning and executing daily production activities of plant & preparing daily report regarding Batch time cycle monitoring, yield trend report, WIP report

•Working experience with Distributed Control System (DCS) and related documents.

•Well versed in manufacturing of APIs in multi-product plant and QMS in API.

Professional Experience:

•Organization –

M/S. IPCA Laboratories Ltd, Ranu (Vadodara, Gujarat). From May. 2019 till date

Designation – Sr. Executive(Production).

Role - Responsibilities

•Prepare batch charging schedule based on monthly production planning.

•Planning and executing daily production activities of plant & preparing daily report regarding Batch time cycle monitoring, yield trend report, WIP report

Does the activity of safety data compilation like near miss & SBO details including PHA.

•Indent management along with daily consumables & other necessary stocks of plant related to CAPEX in IMS System.

•Co-ordinate with store/ ware house to indent required qty of raw material as per plan.

•Prepare necessary documentation system like SOP; BPCR, ECR, and Training record etc to maintain cGMP system.

•Preparation to comply statutory audit, customer audit and regulatory audit.

•For smooth production activity Co-Ordinate with different Dept. like Eng, QC, QA, Ware house, EHS.

•Ensure to compliance cGMP / EHS, Guideline.

•Monitor process parameter & ensure to record deviation and it’s CAPA in Trackwise System.

•Record and monitor yield against std yield.

•Online review of BPCR and respective usage log book.

•Handling of QMS related activity like deviation, change control in Trackwise System.

•Preparation of necessary documents like PVP, PVR, SOP, MPCR, Risk assessment report.

•Preparation of investigation report of OOS & OOT.

•To perform SCM related activities.

•To take follow up about all 12 guidelines of safety for GIC-2.

Achievements:

•Successfully faced and cleared the audits - Internal, CQA, Externals like customer audits without any data integrity (DI) observations.

•Maintained the classified area as per GMP guidelines.

•Rectification of hurdles of the plant operators related to their operations by help of maintenance persons & by arranging the required resources to ease unit operations.

•Stock re-conciliation along with any time auditable condition of the available stock .

•Organization –

M/S. Pfizer Healthcare India Pvt. Ltd, Aurangabad. (From Sept. 2016 to Feb. 2019)

Designation – Executive Production.

Role - Planning and executing daily production activities of Plant.

Achievements:

•Successfully faced and cleared the audits - USFDA, MHRA and WHO without any data integrity (DI) observations.

•Maintained the classified area as per GMP guidelines and responsible for the dispatch of the Finished Products.

•Validated HVAC (Heating Ventilation and Air Conditioning) system with help of External Agency and report prepared.

•Visual Inspections of the Equipments performed successfully after the Product changeover cleanings.

•Organization –

M/S. Hospira Healthcare India Pvt. Ltd., Aurangabad. ( From July 2014 to Sept. 2016)

Designation – Executive Production.

Role - Planning and executing daily production and dispatch activities of Powder Processing Area.

Achievements:

•Expertise Pre Start-up Safety Review (PSSR).

•Ensured Continuous coaching, mentoring and training to subordinates.

•Ensured the pest control activities and kept the plant free from insects and pests as per SOP.

•Organization –

M/S. Orchid Pharmaceuticals Ltd., Aurangabad. (From Aug. 2007 to July 2014)

Designation - Officer, Junior- Executive.

Role - Executing daily production and dispatch activities of Powder Processing Area.

Achievements:

•Temperature uniformity study for the storage areas performed as per Validation Master Plan.

•Handled various equipments like reactors, centrifuge, dryers, millers and sparkler filters etc

•Organization –

M/S. CIPLA Ltd. Daund (Kurkumbh) (From Nov-2005 to Aug.-2007)

Designation: Management Staff.

Role: Operator in Manufacturing of APIs.

Achievements:

•Achieved targeted yield with quality within time line.

•Handled various equipments like reactors, centrifuge, dryers, millers and sparkler filters etc.

•Organization –

M/S. Sun Pharmaceuticals Ltd. Ahmadnagar, Maharashtra, From Nov-2004 to Nov-2005

Designation: –Trainee Production Officer.

Role: Trainee Operator in Manufacturing of APIs.

Achievements:

•Understood the different unit operations and handled the equipment like reactors, centrifuge, dryers, millers and sparkler filters etc.

Academic Qualification:

•Diploma in Chemical Engineering (year of passing 2004) from MSBTE (Institute:- Padmashri Dr. Vitthalrao Vikhe Patil Institute of Technology and Engineering Polytechnic Pravaranagar)

Professional Development:

•Behavior, Technical Writing, Communication Skills program attended.

•Safety Squad Member.

•ICH Q7 – GMP, Data Integrity (DI) and Good Document Practice (GDP) training session attended.

Other:

•Current CTC :8.95 Lakh

•Expected Salary: As per company Policy

•Notice Period:01 Month

Contact this candidate