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Quality Manager

Location:
Hightstown, NJ
Posted:
February 21, 2020

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Resume:

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



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