Kadiyam Rajesh
Quality Assurance
Eluru,AP
Summary
To secure a challenging position where I can effectively contribute my skills as Pharmaceutical Professional, possessing competent Technical Skills while being resourceful, innovative and flexible.
I am sincere, hardworking and responsible. My deterministic nature and self-confidence gives me the strength to face challenges. I am punctual and optimistic. I strongly believe in the words, "Coming together is beginning, keeping together is progress and working together is Success".
Overview
6
6
years of professional experience
3
3
Languages
Work History
QA Executive
Dr. Reddy's Laboratories FTO11
05.2023 - Current
- Ensuring the cGMP conditions are following during Manufacturing,Filling & Packing activities.
- Line clearance for manufacturing,Packing & WH activites.
- Cross verification of dispensed of Raw materials, Primary, secondary and tertiary packing materials from warehouse as per batch size.
- Performing In-process checks during filling, vial collection& packing .
- Performing Pre checks & Post checks to manufacturing loads , filling parts loads,seals and stoppers loads &miscellaneous loads in autoclave.
- Involving in different sampling stages like Bulk sampling (filtered&unfiltered), Hold time sampling, finished product sampling.
- Review and compliance of eBPAR& eBMR(PAS-X)
- Review media fill & Smoke study video records.
- Review batch wise audit trails & trimonthly audit trails in equipment
- Involving in QMS activities like Change control , Incident investigation, Market complaints investigations, CAPA and Internal audits.
- Performing monthly GEMBA walk in Manufacturing ,filling & packing areas
- Led a team of QA , providing guidance, support, and mentorship to improve individual performance and overall team productivity.
- Conducted root cause analysis for identified defects, recommending corrective actions to prevent future occurrences.
- Facilitated knowledge sharing among team members through effective communication channels such as meetings, presentations, and training sessions.
- Managed and archived quality documentation and participated in internal and external quality audits.
QA Executive
Aurobindo pharma ltd
07.2019 - 05.2023
- Ensuring the processing activities are performed as per respective standard operating procedures
- Ensuring the cGMP conditions are following Packing activities
- Involve in QMS activities like Change control, PNC investigation, Market complaint investigation, CAPA and internal audits
- Involve in CSV activities like eBPR & eLOG qualification projects
- Administration activities like verification of time in different equipment vs Digital clock, Use ID creation &deactivation, password reset& Data backup, retrieval, data export.
- Reviewing computerized system validation deliverables like URS ,Validation plan, HLRA, GxP assessment, ER-ES assessment & GAMP categorization.
- Having knowledge in Validation approach (Concept, Project,planning,retirement phases & IQ, OQ, PQ as per GAMP category and 21CFR Part 11
- Performing Line clearance verification in WH, Primary& secondary Packing areas.
- Performing Inprocess checks during Primary and secondary packing activity.
- Cross verification of dispensed Raw materials, Primary, secondary and tertiary packing materials from warehouse as per batch size.
- Performing sample collection in packing area like Reserve samples,stability samples,Validation samples.
- Handling of control samples like registrations,withdraw during investigations, annual visual inspections, Dispensing for additional analysis and destruction of expired reserve samples in LIMS software.
- Involved in execution of Packing validation
- Monthly review of log books & Manual BPAR Review .
- Giving trainings to new joiners providing guidance, support, and mentorship to improve individual performance and overall team productivity.
Education
Bachelor's - Pharmacy
Nova College of Pharmaceutical Education And Research
Vijayawada, Krishna District, India01-2017
Biological Sciences
St. Vincent Depaul Jr College
Eluru, India 04.2001 -
St. Xavier's T.M. High School
Eluru, India01-2010
Skills
MS OFFICE
undefinedAreas Of Interest
- Quality Assurance (IPQA, QMS)
- CSV (QA- IT)
Audit Experience
- Involved in Regulatory audits like EuGMP, MALTA, ANVISA, TANZANIA, German, US FDA.
- Ethiopia audits, customer audits like Orion, puren-Germany, Mylan & safety audits, Internal audits.
Personal Information
- Father's Name: Gaspar
- Date of Birth : 30/08/1995
- Gender : Male
- Marital status : Married
Hobbies
Playing sports
Reading books
Listening songs
Disclaimer
Here I am declaring that above all information is true to the best of my knowledge and belief.
Timeline
QA Executive
Dr. Reddy's Laboratories FTO11
05.2023 - Current
QA Executive
Aurobindo pharma ltd
07.2019 - 05.2023
Biological Sciences
St. Vincent Depaul Jr College
04.2001 -
Bachelor's - Pharmacy
Nova College of Pharmaceutical Education And Research
St. Xavier's T.M. High School
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