SHUBHAKAR JAKKI
Manufacturing Quality Assurance
HYDERABAD
Summary
Dedicated Manager with over 10 years of experience in supervision, operations management, quality management, training, project management and cross-functional communication. Team player with expertise managing staff for efficient production. Detail-oriented scheduler seeking to leverage background into managerial role with progressive organization. Results-focused and proactive in planning day-to-day operations and solving service issues. Offers advanced abilities in tackling issues impacting team and business success. Excels at managing team and personal time to consistently exceed expectations.
Overview
10
10
years of professional experience
5
5
years of post-secondary education
1
1
Certification
1
1
Language
Work History
Deputy Manager QA
GRANULES INDIA LTD
02.2015 - Current
- Participating as representative of Operational QA team (Team Size: 25 Members) to assist different areas of QA functions.
- Implementation of GMP at workplace.
- Handling of Deviation Investigations applying Root Cause Analysis Tools.
- Handling of Change controls.
- Handling of Risk Assessments.
- Handling of OOT Manufacturing Investigations.
- Handling of OOS Manufacturing Investigations.
- Handling of e-QMS, e-DMS and LMS.
- Handling and Approvals of Trainings in Nichelon system.
- Handling of Annual Product Quality Review (APR).
- Play an important role on handing of Market Complaints (US, UK, ROW) and investigation for its compliance (Minor, Major, Critical) including implementation & effectiveness of CAPAs.
- Ensuring of 21CFR compliance for all manufacturing equipment's (Backup Verification of Batch Data reports, Alarm Reports, Event reports and Audit trail reports).
- Used excellent problem-solving and issue-resolution strategies to rectify difficulties quickly and effectively.
- Maintained positive, professional working environment to optimize staff and customer satisfaction.
- Monitored staff performance and developed improvement plans.
Senior Executive
BAFNA PHARMACEUTICALS LTD.
07.2013 - 01.2015
- Handling of IPQA (Manufacturing QA) functions.
- Handling of APQR.
- Vendor Management.
- Manufacturing Investigations.
- Implemented training and development programmes for new employees to successfully exceed retention targets.
- Met individually with employees to offer feedback and insight on job tasks based on careful review.
- Directed hiring and training of new officers to drive organizational improvements.
QA Officer
Medreich Limited (A meiji-seika group)
01.2012 - 07.2013
- Line clearance to different manufacturing areas i.e
- Dispensing, Granulation, Blending, Compression, Capsule filling, sachet filling, bottle and blister packing areas
- SAP Postings after each sample withdrawal
- Hold time study
- Batch card issuance
- Executed BMR/BPR review QC data review.
- COA-Certificate of Analysis Approvals.
- Batch release.
- Finished product container check at warehouse.
- Warehouse assurance.
- Ensured products met manufacturing specifications by measuring dimensions and testing functionality.
- Managed thorough compliance checks, supporting manufacturing teams in delivering safe, compliant goods.
- Coordinated and participated in internal and external quality management system audits to guarantee product and quality specifications.
- Performed thorough quality investigations, identifying key development strategies and supporting idea implementation.
QA CHEMIST
MEDOPHARM
11.2009 - 12.2011
- Review of Experimental, Exhibit Protocols, Reports and execution.
- Review of Process Validation Protocols, Reports and execution.
- Issuance/Review/Approval of BPRs/BMRs.
- Batch releases by reviewing BMR/BPR and QC Data in SAP.
- Managed product trials, including collecting, analyzing data and presenting findings to project teams.
Education
Master of Science - Organic Chemistry
01.2006 - 11.2011
Studied 2 years Master of Science in Organic Chemistry major.
Bachelor of Science - Biotechnoogy,Zoology,Chemistry
03.2004 - 04.2006
Completed 3 year Graduation i.e. Bachelor of Science in Bio-technology, Zoology and Chemistry as 3 major degree. where in Biotechnology sub-majors Micro biology, Bio chemistry and Bio statistics studied.
Skills
E-DMS (Document Management System)undefined
Certification
Lean six sigma yellow belt certified quality manager
Personal Traits
- Staff recruitment
- Staff coaching
- Dynamic leadership
- Team motivation
- Conflict resolution expertise
- Quick decision-making
- Regulatory requirements understanding
- Outstanding customer service
Timeline
Deputy Manager QA - GRANULES INDIA LTD
02.2015 - Current
Senior Executive - BAFNA PHARMACEUTICALS LTD.
07.2013 - 01.2015
QA Officer - Medreich Limited (A meiji-seika group)
01.2012 - 07.2013
QA CHEMIST - MEDOPHARM
11.2009 - 12.2011
Periyar University-MCAS College - Master of Science, Organic Chemistry
01.2006 - 11.2011
Kakatiya University-CD College - Bachelor of Science, Biotechnoogy,Zoology,Chemistry
03.2004 - 04.2006
Similar Profiles
Dileep Kumar KosuriDileep Kumar Kosuri
Deputy manager-Exhibit QC at Granules india ltdDeputy manager-Exhibit QC at Granules india ltd
Mahesh SivayogiMahesh Sivayogi
GxP System Qualification & Compliance at Granules India limitedGxP System Qualification & Compliance at Granules India limited
Viswanath Tejeswi JonnalagaddaViswanath Tejeswi Jonnalagadda
DATA ANALYST - STRATEGY at GRANULES INDIA LIMITEDDATA ANALYST - STRATEGY at GRANULES INDIA LIMITED