Satish Gopal Rane
Mapusa
Summary
With 17 years of experience in pharmaceutical industry, I have developed a reputation for my expertise in leading teams in the Quality Control area to produce good quality drug. My track record of regulatory compliance, project management and process optimization speaks to my ability to oversee complex operations with efficiency and accuracy. My background in chemistry allows me to understand unique requirements of the pharmaceutical industry and make informed decisions that drive results. Having experience in handling multiple dosage forms & export pharmaceutical formulations like Tablets, Capsules, Injectable & Aerosols.
Excel in team leadership, problem-solving, and communication, using these soft skills to drive successful project completions and maintain standards of excellence across all operations.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Quality Control Manager
Sigma Laboratories PVT LTD
Mapusa
06.2020 - Current
- Accountable for Quality control operations in the organization.
- Responsible for implementing and monitoring quality systems, procedures, standards as per requirement from customer or regulatory guidelines.
- Amenable for product release at site by managing a team of Raw/Packed Material and Finished goods planners leading forecasting & planning for manufacturing operations of a plant.
- Qualified auditor in the organization to conduct internal audit as well as vendor audits as per schedule.
- Responsible for ensuring adequate cGMP controls are in place as per marketing countries and quality compliance.
- To ensure audit readiness of the department aligning the team in audit preparation, readiness and response to the observations and defining CAPA actions.
- Monitoring and tracking of various compliance actions that arise due to regulatory inspections and internal audits.
- Responsible for review of change controls, deviations, other quality system investigations such as OOS, OOT, Incident, Breakdown investigations.
- Review of vendor qualification documents such as audit report, certifications provided by vendor, quality agreement and ensuring the documentation is compiled as per cGMP requirements.
- Execution of internal audits within the organization.
- Monitoring of analytical method validations, method transfer as per the regulatory submission.
- Responsible for conducting vendor & external lab audits as per schedule.
- Responsible for resolving customer queries related to analytical data.
Executive QC
Indoco Remedies Ltd
Verna
07.2017 - 06.2020
- Ensuring adequate cGLP controls are in place as per quality compliance in QC department.
- Responsible for review of quality system investigations such as OOS, OOT, Incident, Deviations related to QC.
- Preparation as well as revision of quality documents such as SOP's, Specifications, MOA's qualification protocols and reports.
- To ensure audit readiness of the department aligning the team in audit preparation, readiness and response to the observations and defining CAPA actions.
- Installation and Qualification of new instruments, Software's.
- To maintain inventory of reference standards, calibration standards, primary standards as per current lot.
- Perform evaluation of revalidation of QC instruments and equipment's.
- Yearly maintenance and troubleshooting of Analytical instruments.
- Qualification of working standards.
- To keep track of calibration scheduler for the instruments used in QC laboratory.
- Responsible for Chemical management and ensuring availability of consumables in QC.
Senior Officer
Merck Ltd
Ponda
07.2013 - 07.2017
- Accountable for analysis & planning of finished products and raw material releases.
- Providing support for the review of Finish product & Stability sample reports.
- Responsible for preparation and control of working standards.
- Issuance and maintenance of Reference standards.
- Calibration & Troubleshooting of Analytical instruments.
- Liable for training of new joiners in QC.
- Member of six sigma quality control team.
Quality Control Officer
Wyeth Ltd
Verna
06.2010 - 06.2013
- Responsible for analysis of routine samples of finished products, process validation, raw materials, packaging materials.
- Responsible for calibration and maintenance of all instruments in Quality control.
- Responsible for Maintenance of ETP laboratory.
- Achievement - Completion of six sigma yellow belt project.
Quality Control Officer
Glenmark Pharmaceuticals Ltd
Mapusa
01.2010 - 05.2010
- Analysis of finished products samples.
- Analysis of packaging materials.
Quality Control Officer
Medispray PVT. LTD.
Ponda
06.2008 - 12.2009
- Responsible for Analysis of In-process & Finish product samples.
- Responsible for Maintenance & Calibration of UV Visible spectrophotometer.
- Complete Analysis of finished product of Aerosol as per IP, BP, USP, Ph. Eur.
- Performed tests such as Assay, Emitted dose, Fine particle dose test, Uniformity of Delivery dose etc.
Education
Master of Science - Analytical chemistry
Mumbai University
MumbaiBachelor of Science - Chemistry
Mumbai University
MumbaiH. S.C. - Physics, Chemistry & Mathematics
Kolhapur Board
S.S.C. -
Kolhapur Board
Skills
- HPLC
- GC
- UV-Visible Spectrophotometer
- FTIR Spectrophotometer
- Dissolution
- KF-Autotitrator
- PH Meter
- Analytical Balances
- UPLC
- Internal audit
- Analytical data review
- Communication
- Interpersonal skills
- Attention to detail
- Vendor audits
- Planning
- Execution
- Ability to work in fast paced environment
- Ability to work in demanding environment
- Ability to work in timeline driven environment
Certification
- Goa FDA Certification, Successfully completed the Goa FDA interview and formalities to obtain certification as an approved chemist for working in Quality Control Department.
- Yellow belt holder, Completed lean and six sigma project which reduces or eliminates non value added activities.
- Certified auditor course, Completed training on risk based approach to strengthen audit program by Qualistery team.
Personal Information
- Date of Birth: 10/20/85
- Gender: Male
- Nationality: Indian
- Marital Status: Married
- Religion: Hindu
Languages
- English
- Hindi
- Konkani
- Marathi
References
Shall be provided on request.
Additional Information
Ability to handle group of people in a positive way with increasing efficiency and output from every individual., Team Building / Lateral Leadership skills., Planning & Execution of projects as per the set timelines., Proven ability to work in multicultural environment.
Audits Faced
- USFDA
- MHRA
- TGA
- WHO
- EU
Languages
English
Upper Intermediate
B2
Timeline
Quality Control Manager
Sigma Laboratories PVT LTD
06.2020 - Current
Executive QC
Indoco Remedies Ltd
07.2017 - 06.2020
Senior Officer
Merck Ltd
07.2013 - 07.2017
Quality Control Officer
Wyeth Ltd
06.2010 - 06.2013
Quality Control Officer
Glenmark Pharmaceuticals Ltd
01.2010 - 05.2010
Quality Control Officer
Medispray PVT. LTD.
06.2008 - 12.2009
Master of Science - Analytical chemistry
Mumbai University
Bachelor of Science - Chemistry
Mumbai University
H. S.C. - Physics, Chemistry & Mathematics
Kolhapur Board
S.S.C. -
Kolhapur Board