UKESH VIDIYALA
VISHAKAPATNAM
Summary
Experienced Shift Manager with over 13 years at Pfizer,specializing in process validation, CSV, QMS compliance and operational excellence. Proventrack record in leading cross functional teams , enhancing production performance , and ensuring quality standards. Known for excellent problem-solving and communication skills .Aiming to leverage expertise in process and software validation to drive company growth and compliance.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Shift Manager (Autoclave , FFL)
Pfizer
Vishakhapatnam
11.2012 - Current
- Process Knowledge: CSV, process validation, solution preparation, fill finish line, terminal sterilization.
- Supply: Managed solution preparation and fill-finish lines, ensuring efficient terminal sterilization.
- Quality: Maintained 100% compliance with procedures, lead quality improvements, and managed validations and audits.
- Technical Support: Simplify supported computer system installation and qualifications, ensuring smooth operation.
- Performed validation testing of software applications to ensure compliance with user requirements and industry standards.
- Developed test protocols, plans, scripts and reports for system validation activities.
- Created and maintained documentation related to validation activities such as traceability matrices and risk analysis documents.
- Provided technical support in the installation, configuration and qualification of computer systems.
- Conducted functional, performance and usability tests on software applications to ensure quality assurance.
- Executed regression testing to verify that changes made do not impact existing functionality of a product or system.
- Reviewed customer requirements to identify any gaps between the customer needs and the proposed solution design.
- Documented results of all validation tests performed for future reference and audit purposes.
- Prepared summary reports highlighting key findings from the validation process.
- Collaborated with developers in troubleshooting issues identified during the validation process.
- Ensured that all systems comply with applicable regulatory guidelines such as FDA 21 CFR Part 11.
- Established and maintained quality control standards throughout the manufacturing process.
- Coordinated with engineering, purchasing, inventory control, and other departments to ensure that all operational requirements were met.
- Created detailed reports on production performance metrics such as output rate and cycle time.
Education
Master of Science - M-PHARM (Pharmaceutics)
VELS UNIVERSITY
Chennai08-2011
Skills
- Decision-Making
- Attention to Detail
- Problem Resolution
- Excellent Communication
- Organization and Time Management
- Process Validation
- Quality management system (QMS)
- Regulatory Compliance (21 CFR Part 11)
- Team leadership
Accomplishments
- Elimination of chemical indicators at sterilization area.
- Localization of potassium acetate vials required for PRQ of sterilizers.
- Simplification of AMPS (EBR) documentation ) Process at TS , Solution preparation, fill finish line.
- Simplification of procedures.
- Implementation of limited filling changeover
Languages
Telugu
First Language
English
Advanced (C1)
C1
Hindi
Elementary (A2)
A2
Certification
Trained on M1 .
Guidelines
- 21 CFR Part 11
- EU Annex-1
- ISPE-Volume -05 (Commissioning and Qualification)
Timeline
Shift Manager (Autoclave , FFL)
Pfizer
11.2012 - Current
Master of Science - M-PHARM (Pharmaceutics)
VELS UNIVERSITY
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