Kumar Babu K
Quality Assurance
Secunderabad
Summary
Seeking a professional association with an esteemed organization that offers diverse experiences and opportunities to enhance technical skills. Committed to working diligently and embracing challenges to contribute towards achieving the organization's goals.
Overview
20
20
years of professional experience
9
9
years of post-secondary education
2
2
Certifications
Work History
Manager-QA
Nakoda Chemicals Limited
03.2017 - Current
- Accountable for continuous improvement and strengthening of QMS tools in line with guidelines
- Impact assessment and approval of changes proposed as per Change control management
- Handling deviations through investigation – various tools – 5 M, 5 Why, Root Cause Analysis etc., and making sure that critical deviations are investigated and resolved
- Making sure that market complaints are investigated and resolved through handling all necessary communication with the customers
- Making sure that all OOS, OOT and OOC are investigated and resolved with proper documentation
- Establishing a system to release or reject raw materials, packaging and labeling materials, intermediates and APIs
- Handling of returned goods
- Accountable for implementation of all CAPAs and evaluation of its effectiveness
- Approving all specifications and master production instructions
- Review and evaluation of Annual product quality reports – Drawing appropriate CAPA as required
- Internal audit core team member and accountable for compliance of all internal audit observations making sure that internal audits (self-inspections) are performed
- Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution
- Responsible for Product release to market as per customer requirement
- Approving intermediate and API contract manufacturers
- Responsible for approval of various Protocols and Reports and monitoring of online validation activities like Process Validations, Cleaning Validations etc., reviewing and approving validation protocols and reports
- Making sure that effective systems are used for maintaining and calibrating critical equipment
- Making sure that there are stability data to support retest or expiry dates and storage conditions on APIs or intermediates where appropriate
- Performing vendor audits & preparation of Audit reports
- Review and assessment of Vendor qualification documents
- Preparation of audit agenda and audit checklist based on the audit agenda
- Coordination with the end user site for any specific inquiries and Quality issues
- Preparation of audit reports & follow-up with vendors for audit response
- Review and evaluation of audit response and CAPA proposed
- Follow-up with vendors for CAPA updates till closure and preparation of closure report
- Qualification of equipment, water system & HVAC
- Actively involved in checking the automated PLC system for GMP & 21 CFR part 11 req
Assistant Manager-QA
Nakoda Chemicals Limited
05.2016 - 02.2017
- Preparation and Review of APQRs
- Compliance verification of SOPs against vs guidelines
- Responsible for all Updates of SMF, VMP, yearly schedules and calendars
- One point contact for all Quality related issues with customers and investigation of all customer complaints
- Batch release of finished product, Handling Change control and Deviations
Assistant Manager-QA
Vasudha Pharmachem Limited
11.2015 - 04.2016
- Responsible for Vendor Management
- Responsible for approval of various Protocols and Reports and monitoring of online validation activities like Process Validations, Cleaning Validations etc
Assistant Manager-QA
Nakoda Chemicals Limited
04.2014 - 10.2015
Sr. Executive-QA
Nakoda Chemicals Limited
07.2008 - 03.2014
Chemist-QA
Arch Pharma Labs Ltd
10.2006 - 06.2008
- Responsible for document issuance, receipt and archival of all documents and review of BMRs
- Handling of all finished product dispatch activities
- Helping hand for QMS management
Shift in-charge (Production)
Satyadeva Pharmaceuticals Ltd
08.2005 - 09.2006
- Responsible for review and approval of on line BMRs
- Responsible for all production activities in the shift
Education
B.Sc. - Mathes, Physics & Chemistry
Nagarjuna University
01.1994 - 01.1999
Intermediate - M.P.C
Board of Intermediate (A.P)
01.1991 - 01.1994
S.S.C - undefined
Board of Secondary School Education (A.P)
01.1990 - 01.1991
Skills
MS Word
Certification
Certified ISO 9001: 2015 Lead Auditor, GRS Certification Affiliated by Exemplar Global, GTQ/G076/04, 03/15/2023
Career Path
- Manager-QA, Nakoda Chemicals Limited, Hyderabad, 03/01/2017, Present
- Assistant Manager-QA, Nakoda Chemicals Limited, Hyderabad, 05/01/2016, 02/28/2017
- Assistant Manager-QA, Vasudha Pharmachem Limited, Vizag, 11/01/2015, 04/30/2016
- Assistant Manager-QA, Nakoda Chemicals Limited, Hyderabad, 04/01/2014, 10/31/2015
- Sr. Executive-QA, Nakoda Chemicals Limited, Hyderabad, 07/01/2008, 03/31/2014
- Chemist-QA, Arch Pharma Labs Ltd, Hyderabad, 10/01/2006, 06/30/2008
- Shift in-charge (Production), Satyadeva Pharmaceuticals Ltd, Hyderabad, 08/01/2005, 09/30/2006
Personal Information
- Date of Birth: 02/28/1975
- Gender: Male
- Marital Status: Married with One Female child, 21 Years doing computers engineering
Attributes
- Hard working, Responsible by nature
- Self-starter and ability to prioritize
- Problem solving skills and accuracy and Attention to detail
- Proper planning and Logical thinking
- Logical thinking with Positive attitude
Learning about trading
Watching business news and keeping update on daily share markets.
Timeline
Manager-QA
Nakoda Chemicals Limited
03.2017 - Current
Assistant Manager-QA
Nakoda Chemicals Limited
05.2016 - 02.2017
Assistant Manager-QA
Vasudha Pharmachem Limited
11.2015 - 04.2016
Assistant Manager-QA
Nakoda Chemicals Limited
04.2014 - 10.2015
Sr. Executive-QA
Nakoda Chemicals Limited
07.2008 - 03.2014
Chemist-QA
Arch Pharma Labs Ltd
10.2006 - 06.2008
Shift in-charge (Production)
Satyadeva Pharmaceuticals Ltd
08.2005 - 09.2006
B.Sc. - Mathes, Physics & Chemistry
Nagarjuna University
01.1994 - 01.1999
Intermediate - M.P.C
Board of Intermediate (A.P)
01.1991 - 01.1994
S.S.C - undefined
Board of Secondary School Education (A.P)
01.1990 - 01.1991
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