DHARA VIROJA
Windsor Locks,CT
Summary
Smart decision-maker promoting [Number] years of expertise in [Industry]. Educated and talented to work in demanding environments.
Offering solid foundation in regulatory principles and compliance best practices, eager to develop within professional setting. Brings ability to quickly grasp complex regulations and apply critical thinking to compliance challenges. Ready to use and develop analytical and problem-solving skills in [Desired Position] role.
Diligent [Desired Position] with solid background in regulatory compliance and risk management. Successfully implemented compliance programs and policies, ensuring adherence to industry standards and minimizing risk. Demonstrated effective problem-solving and communication skills in fast-paced environments.
Overview
13
13
years of professional experience
Work History
Quality Assurance Compliance Specialist
SCA Pharma
12.2021 - Current
- Implemented robust record-keeping systems that ensured accurate documentation was maintained according to regulatory requirements at all times.
- Served as a point of contact for employees seeking guidance on compliance matters, instilling confidence in the organization''s commitment to regulatory adherence.
- Assisted in the preparation of regular reports for senior management, detailing compliance activities and progress towards established goals.
- Reduced instances of non-compliance through meticulous monitoring of internal controls and periodic audits.
- Evaluated existing policies regularly, identifying areas for improvement and recommending revisions as needed.
- Managed quality programs to reduce overdue compliance activities.
MQA Specialist
SCA Pharma
11.2019 - 11.2021
- Followed all company policies and procedures to deliver quality work.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Maintained accurate records of drilling progress, ensuring proper documentation for management review.
Compounding Technician
SCA Pharma.
06.2017 - 11.2019
- Compound various lifesaving medications according to Standard Operating Procedures in an ISO5 area (in LAFH) in a Clean Room
- Knowledge of calibrating scale
- Also has experience of filling CADD cassettes and Life care Vials
- Have to document all the steps in Batch Records by following Good Documentation Practice
- Have also worked with Review of Master Batch Record and having correction done according to GDP
Pharmacy Technician
CVS Pharmacy.
01.2017 - 06.2017
- Filling prescription in the RX connect system
- Acquired knowledge of medication dosage
- Work under direct supervision of pharmacist
- Direct interaction with customers
- Answer questions of customers and solve their queries
- Re-fill medicine dosages
Analytical Chemist
E-CHEM GROUP INC.
11.2011 - 02.2013
- Company Overview: (Out sourcing group working for Chemtech Environmental laboratory, Mountainside, New Jersey)
- Led quality assurance program to ensure that the data is reliable and discover any discrepancy in data
- Interpretation of GC-MS generated chromatogram by MSD Chemstation and thereby analyzing the amount of semi volatile compounds present in water samples like drinking water and waste water or soil samples
- Trained to make8270 Method calibration standards by quanting the standards ran on GC-MS instrument then use this method of quanting water or soil samples
- Drafted technical reports with accurate interpretations of analytical data using Chemstation, LIMS, EISC, MS excel and word
- Assisted the team for internal and external audits
Education
Master of Science - Pharmaceutical Chemistry
Ashok & Rita Patel Institute of Integrated Study & Research in Biotechnology & Allied Sciences
04.2011
Bachelor of Science - Biotechnology
Natubhai V. Patel College of Pure & Applied Sciences
India04.2009
Skills
- Documentation skills
- Corrective action plans
- Documentation review
- Corrective actions
- Critical thinking
- Records management
- Project oversight
- SOP development
- Master Control (DMS system), LIMS and SAGE system
- Training co-ordinator
- Management collaboration
- Root-cause analysis
- Team collaboration
- Continuous improvement
- Attention to detail
Timeline
Quality Assurance Compliance Specialist
SCA Pharma
12.2021 - Current
MQA Specialist
SCA Pharma
11.2019 - 11.2021
Compounding Technician
SCA Pharma.
06.2017 - 11.2019
Pharmacy Technician
CVS Pharmacy.
01.2017 - 06.2017
Analytical Chemist
E-CHEM GROUP INC.
11.2011 - 02.2013
Master of Science - Pharmaceutical Chemistry
Ashok & Rita Patel Institute of Integrated Study & Research in Biotechnology & Allied Sciences
Bachelor of Science - Biotechnology
Natubhai V. Patel College of Pure & Applied Sciences
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