ASHOK KUMAR K
Vishakapatnam
Summary
Experienced professional with over 14 years of experience in the pharmaceutical industry. Skilled in QMS, investigations, CAPA, change control, risk assessment, SOP management, GMP compliance, and audit management. strong track record of leading cross-functional teams and driving continuous improvement.
Overview
14
14
years of professional experience
Work History
Deputy Manager
Eugia sterile facility
Vishakapatnam
05.2025 - Current
- Led production quality management system to ensure compliance with CGMP and regulatory requirements.
- Reviewed and approved deviations, CAPAs, change controls, investigations, and SOPs to ensure compliance and operational integrity.
- Partner with production, engineering, QC, warehouse and validation teams to improve quality performance.
- Conducted trend analysis and implemented continuous improvement initiatives to enhance quality management processes.
- Drove employee GMP awareness and fostered quality culture through targeted training programs.
- Trained team on critical investigation preparation and ensured timely closure of QMS elements including CMS tasks, CAPAs, action items, and effectiveness checks.
- Perform quality risk assessments for process and equipment changes.
- Coordinate internal and external regulatory inspections and customer audits.
Production Team Member
Dr. Reddy's
Vizag
08.2021 - 05.2025
- Conducted investigations for deviations, non-conformances, and quality events to identify root causes and implement effective corrective actions.
- Evaluated and managed Change Controls to ensure regulatory compliance and controlled implementation of process improvements.
- Assessed and reviewed Corrective and Preventive Actions (CAPAs) to verify effectiveness and prevent recurrence of quality issues.
- Performed Quality Risk Assessments (QRM/FMEA) to identify, evaluate, and mitigate process and product risks.
- Prepared and reviewed qualification, validation, and quality protocols in compliance with GMP and internal procedures.
- Ensured compliance with regulatory requirements and strengthened operational integrity through robust quality management practices.
Sr. Executive
Mylan Laboratories
Hosur
11.2015 - 08.2021
- Conducted investigations for deviations, non-conformances, and quality events to identify root causes and implement effective corrective actions.
- Evaluated and managed Change Controls to ensure regulatory compliance and controlled implementation of process improvements.
- Assessed and reviewed Corrective and Preventive Actions (CAPAs) to verify effectiveness and prevent recurrence of quality issues.
- Performed Quality Risk Assessments (QRM/FMEA) to identify, evaluate, and mitigate process and product risks.
- Prepared and reviewed qualification, validation, and quality protocols in compliance with GMP and internal procedures.
- Ensured compliance with regulatory requirements and strengthened operational integrity through robust quality management practices.
Production Officer
Hospira Health Care
Chennai
06.2012 - 11.2015
- Prepared compounding solutions, enhancing production process efficiency.
- Performed CIP, PHT, and SIP of manufacturing vessels, ensuring cleanliness and regulatory compliance.
- Conducted filter integrity tests, verifying operational reliability and maintaining product quality.
Education
MSc - Distance education
Sri Venkateshwara University
BSc - chemistry
Sri Chaitanya Degree College
INTERMEDIATE -
Srinivasa Junior College
SSC -
Vijnana Bharathi
Skills
- Regulatory compliance
- CAPA oversight
- Audit management
- Internal audits
- Quality assurance
- Change management
- Risk analysis
- Process improvement
- Production efficiency
- Issue resolution
- Teamwork
Accomplishments
- Reduced deviations and CAPA closure timelines thorough process improvements and on-time closure metrics.
- Improved QMS compliance through SOP optimization and training.
- Led implementation of quality improvemnt projects across manufacturing operations.
- Led successful regualtroy inspection readiness activities.
STRENGTHS:
- Hard working
- Self-Confident
- Ability to work in multi-cultural environment and encouraging personalize
Hobbies and Interests
Playing cricket., Cooking.
Disclaimer
I hereby declare that the above details furnished here are true and correct to the best of my knowledge Applicant’s Signature : ASHOK KUMAR.K
Personal Information
Languages
English, Telugu, Tamil
Timeline
Deputy Manager
Eugia sterile facility
05.2025 - Current
Production Team Member
Dr. Reddy's
08.2021 - 05.2025
Sr. Executive
Mylan Laboratories
11.2015 - 08.2021
Production Officer
Hospira Health Care
06.2012 - 11.2015
MSc - Distance education
Sri Venkateshwara University
BSc - chemistry
Sri Chaitanya Degree College
INTERMEDIATE -
Srinivasa Junior College
SSC -
Vijnana Bharathi