Beena Patel, Quality Associate (Operations)
I am a working professional with 4 years of expertise in Pharmaceutical Quality Assurance experience. I have worked in a Consent Decree environment and fully understand the importance of compliance. With exceptional interpersonal skills, I am a problem solver and detail-oriented individual. As a skilled leader, I am focused on achieving success and increased productivity through improvements in operations, safety and quality.
SKILLS
WORK EXPERIENCE
Quality Associate (Operations)
AmerisourceBurgen Pharmedium
03/2019 – Present
Dayton, NJ
Achievements/Tasks
Adheres to all cGMP, safety regulations and understands QA SOP’s with minimum supervision
Assist the Quality Supervisor with all quality operations and responsibilities at the Pain Management facility
Ensure compliance to procedures and address non-compliance issues
Provide support to management during all regulatory inspections
Participate in cross-functional teams to identify effective corrective and preventive instructions to improve process quality
Daily activities will include but not limited to: pooling, subassembly and final batch processing, label and packing, environmental monitoring, training of specific procedures
Conduct root cause analysis for compounding errors and in- process errors generated at the facility during all phases of the production process
Assist Quality Manager in assuring the timely closure of incident complaints
Write, review and revise SOP's as needed to assure compliance and continuous improvement
Perform review of quality related documents generated at the facility
Verification of Environmental Monitoring Report
Perform and Review Label verification activity
Perform Final Documented review of Scrap, Reject and Canceled Batch paperwork
Perform final documented review of completed batch paperwork prior to shipment and final review of all other GMP documents
Documentation responsibilities include the initiation of SOP changes, processing new and revised SOPs, maintaining Preventative Maintenance and Critical Systems documentation
Assist in training of new staff on Good Documentation Practices and batch record review process
Perform other duties and responsibilities as assigned
Quality Assurance
Navinta LLC
03/2019 – 11/2016
Ewing Township, NJ
Achievements/Tasks
Maintain all quality related documents including SOPs, regulatory documents, batch records, audit reports, and deviation reports while ensuring adherence to and compliance with, established company quality policies, practices, SOPs, and GMP/FDA regulations
Reviewing R & D report, Maintains and update calibration records for all QC equipment. Audit calibration documents ( IQ, OQ, and PQ ) Periodic review, revision, and implementation of SOPs as required. Maintain the master copy, control copy and obsolete copies for SOPs. Assist with all quality related inspections as required
Assist QA manager in internal quality audits for compliance with cGMP
Inspect and approve rooms and equipment prior to use by manufacturing and R&D personnel
Inspect and approve rooms for Sampling of raw materials and packaging materials. Prepare and verify sampling documents
Prepare Quarantine, Approved or Rejected Labels and affixed as per requirements after auditing respective documents.
Log in of different Samples such as Raw materials, Packaging materials, In-Process samples, finished product samples, stability samples and R&D samples for analytical testing
Approval of USP water system checks
Maintain all finished products, raw materials and stability Specification sheets and CoA
Review and Maintain Stability protocols
Execute stability and pull out stability samples as per Stability Protocol
Calibration of QC analytical balances
Maintain all training records of all employees
EDUCATION
Bachelors of Science Microbiology
Sardar Patel University
Gujarat, India 1998
Medical Laboratory Technician
Vivekananda College
Gujarat, India 1999
LANGUAGES
English
Guajarati
Hindi
STATUS
-Green Card Holder
REFRENCES
-Available upon request