RAJASHEKAR ATLA
Hyderabad
Summary
I am a dedicated Quality Assurance professional with extensive experience in the pharmaceutical industry, specifically within the Quality Assurance departments of leading companies. My expertise includes auditing, ensuring compliance with GMP standards, and facilitating corrective actions to maintain high-quality safety standards. I have proven skills in coordinating cross-functional teams and ensuring thorough documentation to meet regulatory requirements.
Overview
10
10
years of professional experience
Work History
Sr. Executive, Quality Assurance
Aurobindo Pharma Ltd.
06.2021 - Current
- Company Overview: Aurobindo Pharma is USFDA, WHO, and MHRA approved company.
- Responsible for giving line clearance at various stages of activity like dispensing, packing, and liquid manufacturing by ensuring the cleanliness of area and equipment.
- Monitoring of environmental conditions in all process areas.
- Reviewing executed Batch packing and Master Packing records.
- Utilized track and trace data to respond effectively to market complaints and recalls, ensuring quick identification of affected batches and minimizing potential impacts onproduct availability.
- Conducted impact assessments for proposed changes, successfully identifying and mitigating potential risks to product quality and safety.
- Evaluate CAPA effectiveness by monitoring implementation and assessing outcomes to prevent recurrence of issues.
- Monitoring handling of rejects.
- Stability follow ups with QC and AQA departments.
- Reporting GMP violation observations and process non-conformances.
- Monitoring process including, environment, equipment, procedures, personnel,cGMP.
- Collection of samples at regular intervals.
- Conduct simulation studies to investigate market complaints, analyzing results to recommend process improvements and corrective actions.
- Verification of logbooks.
- Labelling,coding proof checking, reconciliation of materials.
- Posting the batch details and analytical data (COA) in PROCESS PAD and ERP.
- Review of executed batch records.
- Performing packing validation and cleaning validation activities as per protocol.
- Preparation for internal and external audits.
- Co ordinate with other cross functional department to achieve the goals.
Executive, Quality Assurance
RA Chem Pharma Ltd.
04.2019 - 05.2021
- Company Overview: RA Chem Pharma is an approved company by USFDA, WHO, MHRA, and TGA
- Performing line clearance activity in packing area.
- Collection of samples.
- Performing inprocess checks.
- Review of executed batch records.
- Monitoring Handling of rejects during packing.
- Batch details coding and handling of rejections in packing area.
- Working in coordination with Production, QC, and Engineering Departments.
Officer, Quality Assurance
Hetero Labs Ltd.
03.2015 - 04.2019
- Company Overview: Hetero Labs is approved by USFDA, MHRA, WHO, and TGA
- Giving line clearance for dispensing activity and packing activity.
- Potency calculation of API at dispensing stage.
- Material verification before dispensing and packing activities.
- Regular verification of logbooks and material status of materials.
- Handling batch planning approval, sampling, and reconciliation.
- Performing calibration of in-process instruments.
- Responsible for daily checking of equipment logs and calibration logs.
Education
B. Pharmacy - JNTU University
Vaageswari Institute of Pharmaceutical Sciences
KarimnagarD. Pharmacy - Pharmacy
Aurobindo College of Pharmacy
Warangal07.2009
Intermediate -
Government Junior College
Karimnagar07.2007
Skills
- IPQA
- Sampling
- PROCESS PAD
- LIMS
- Track and Trace
- Change control Management
- Batch record review
- GMP compliance
- Environmental monitoring
- CAPA evaluation
- Risk assessment
- Internal audits
- Cross-functional coordination
- Regulatory compliance
- Process improvement
- Documentation control
- Quality management systems
- Validation processes
Accomplishments
Audits FACED
USFDA
MHRA
Personal Information
Title: Sr. Executive, Quality Assurance
Languages
English
Telugu
Hindi
Industryexpertise
- Inprocess Quality Assurance
- Change control Management
- Packing Validation
- Cleaning Validation
- Simulation studies for Market Complaints
- Track and Trace
- CAPA implementation and effectiveness follow up
- Problem solving and Root cause analysis
- Batch record review
- PROCESS PAD
- LIMS
Timeline
Sr. Executive, Quality Assurance
Aurobindo Pharma Ltd.
06.2021 - Current
Executive, Quality Assurance
RA Chem Pharma Ltd.
04.2019 - 05.2021
Officer, Quality Assurance
Hetero Labs Ltd.
03.2015 - 04.2019
B. Pharmacy - JNTU University
Vaageswari Institute of Pharmaceutical Sciences
D. Pharmacy - Pharmacy
Aurobindo College of Pharmacy
Intermediate -
Government Junior College
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