Kalyani GOKA
Visakhapatnam
Summary
To seek a challenging career with a progressive organization which will utilize my skills, abilities and education to execute, accomplish and excel for personal and company's growth.
A keen performer & implementer with demonstrated abilities in delivering the results to the assigned tasks independently. Effective communicator with excellent presentation skills.
Overview
8
8
years of professional experience
12
12
years of post-secondary education
2
2
Languages
Work History
Training Specialist
Pfizer Healthcare India Pvt. Ltd.
05.2013 - 02.2021
- Handling of existing employee training-
- Schedule, impart and track inspector qualification/re-qualification trainings to existing employees
- Assign curriculums or courses to employee as per the business requirement
- Issue, retrieve and maintain training documents
- Support to Manager-
- Collection or verification of data in case of deviations related to visual inspection trainings
- Document upkeep and support for all time audit readiness
- Provide training status report - including employee Vs training status, periodic requalification data, deviations due to inadequate training as root cause
- Operating systems handling-
- PDOCS- Preparation, review and approval of documents (SOPs, Protocols, Knapp study reports, defect kit documents)
- Issuance of visual inspector training documents
- PLS (Training Management System)-Upload documents, assign trainings, creation and modification of curriculum and report generation for tracking trainings
- GQTS- Creation, implementation and closure of change controls
- Initiation, investigation and closure of Events/QARS
- Implementation and timely closure of CAPA's
- P-Log-Creation and implementation of electronic logbooks
- SAP- Had experience in SAP for batch manufacturing activities
- Adept at working on MS Excel, MS Word, Power Point and Internet ApplicationsWorked as training specialist for visual inspection activities:
- Monitoring of visual inspection activities
- Review of SOPs, Knapp study reports and Protocols
- Support during FDA inspection, MSQA and Mock audits
- Organizing shop-floor trainings to operators
- Qualified trainer for manual visual inspection of glass vials (clear / amber) and plastic vials, ampoules and emulsion products
- Hands on experience on visual inspection of clear liquids filled in clear glass vials (Tubular and molded), Tubular amber glass vials, Clear glass ampoules and Plastic vials
- Semi-automatic visual inspection program: conduct qualification of semi-automatic visual inspection machine - Maschinpex, Training and qualification of operators for Semi-automated visual inspection
- Conduct training and qualification for incoming containers inspection(Empty glass vials, plastic vials, ampoules, stoppers and seals)
- Knapp study protocol review, monitoring of Knapp study for qualification of automatic visual inspection machine -EISAI
- Procurement of standard defective containers from Micro measurement laboratories and Pfizer Rocky Mount site, arrange for verification of Procured kits and control
- Qualification of In-house prepared defect kits for manual and semi-automatic visual inspection
- Involve in investigations related to AQL failures and market complaints
- AUDITS > US FDA, Pfizer MSQA and Mock audits
Education
Bio Technology Management - GMS
Indian School of Business Management & Administrat
Mumbai 04.2001 - 04.2013
Board of Higher Secondary education - undefined
Andhra Pradesh
Board of secondary education - undefined
Andhra Pradesh
Skills
Training program development
Personal Information
- Date of Birth: 10/02/94
- Gender: Female
- Marital Status: Single
Timeline
Training Specialist
Pfizer Healthcare India Pvt. Ltd.
05.2013 - 02.2021
Bio Technology Management - GMS
Indian School of Business Management & Administrat
04.2001 - 04.2013
Board of Higher Secondary education - undefined
Andhra Pradesh
Board of secondary education - undefined
Andhra Pradesh
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