Indra Bose
Section Head - Quality Control Documentation (QC)
Indore,MP
Summary
Section Head with 8 years of documented quality control success. Develops specific and measurable goals, improvements and standards to continuously and consistently improve quality and reduce and eliminate errors. Successfully audits and maintains product accuracy and timely delivery resulting in customer satisfaction. Initiates quality-related SOP training and enforces procedural adherence.
Overview
1
1
Language
5
5
years of post-secondary education
11
11
years of professional experience
Work History
Section Head - Quality Control
CIPLA Pharmaceuticals
Pithampur SEZ, Madhya Pradesh
04.2015 - 12.2018
- Modeled innovative solutions to respond to organizational needs.
- Produced on-time communications in support of new product submissions for regulatory agencies.
- Monitored over 12 employees' day-to-day activities and made plans to rectify issues resulting in time loss prevention in document control and access
- Collaborated with quality assurance team to comply with regulatory requirements.
- Identified audit parameters to comply with quality standards.
- Provided leadership vision, direction, development and maintenance of multiple complex and high priority contracts between company and business partners, vendors and suppliers.
- Provided staff training and mentorship in preparing communication content for different issue documents meeting inhouse production specifications and proposed external specifications.
- Oversaw performance of team of technical writers, assigned resources, and updated management on projects
- Reviewed document management protocols and user activities against internal records policies and document management standards.
- Utilized CIPDOX to scan and clean up project documents.
Quality Control Analyst
CIPLA Pharmaceuticals
Pithampur, Madhya Pradesh
10.2010 - 06.2015
- Inspected raw materials and finished products specifications to verify quality and disposed items that did not meet safety requirements.
- Created and maintained several databases to track statistical data.
- Developed and maintained quality assurance procedure documentation.
- Compiled and distributed weekly feedback to team leaders and managers to improve service time and quality while increasing productivity.
- Served as information systems liaison with departments and external sources, information services and auditors to make recommendations for optimization of regulatory requirements.
- Kept inspection journals and daily summary logs as required.
- Demonstrated new processes and functionality to department heads, managers and team members.
- Worked with central management to identify, plan, align and address training needs.
- Compiled training handbook and related course materials.
- Minimized down time 50% by reducing production rework and recalls
Subject Matter Expert - QC Documentation
CIPLA Pharmaceuticals
Pithampur, Madhya Pradesh
06.2012 - 04.2015
- Led corporate-wide initiatives to help guide enterprise and business level goals.
- Translated complex technical information into intuitive clear format.
- Remained informed on current regulations, especially concerning research industry and document creation.
- Analyzed specification documents to identify ambiguity and conflicts between documents and specifications.
- Worked with internal team members to remedy issues with preemptive solutions.
- Managed senior-level reviews working across all functions of program.
- Performed duties in accordance with all applicable standards, policies and regulatory guidelines to promote safe working environment - USFDA, MHRA, OSHA and ISO
- Improved man hour profitability by 25% by significantly reducing full-time employee (FTE) hours, maximizing efficiency of new e-documentation organizing software
Education
MBA - Human Resources Management
Symbiosis Institute of Management And Research
Pune 10.2014 - 07.2016
Master of Science - Biotechnology
Barkatullah University
Bhopal 04.2007 - 03.2009
PGDCA - Computer Applications
Makhanlal Chaturvedi National University
Bhopal 06.2008 - 06.2009
Skills
Knowledge of quality systems
Accomplishments
I was awarded the access keys to change specifications (Change Control), this was a highly trusted access only to restricted selected individuals across the company
I lead the project "e-Documentation" where e-documents of 2000 physical specifications and regulatory requirements were uploaded to a central server and access provided to a team working under me
Timeline
Section Head - Quality Control
CIPLA Pharmaceuticals
04.2015 - 12.2018
MBA - Human Resources Management
Symbiosis Institute of Management And Research
10.2014 - 07.2016
Subject Matter Expert - QC Documentation
CIPLA Pharmaceuticals
06.2012 - 04.2015
Quality Control Analyst
CIPLA Pharmaceuticals
10.2010 - 06.2015
PGDCA - Computer Applications
Makhanlal Chaturvedi National University
06.2008 - 06.2009
Master of Science - Biotechnology
Barkatullah University
04.2007 - 03.2009
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