Inprocess Quality Assurance Associate - II Resume - Hire IT People

Objective

I am looking to join a renowned pharmaceutical company Quality Assurance department with a possibility of long - term employment.

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Inprocess Quality Assurance Associate - II

Confidential

Responsibilities:

Capture critical information for customer complaint/deviation/ investigations/ CAPA (when necessary).
Identify, report, document, and trouble shoot Unplanned Deviations.
Perform, support, and document Planned Deviations as per Good Manufacturing Practices (GMP).
Perform complaint sample inspection.
Conduct and verify line clearances (Rooms / Equipment) and components verification.
Review and Approve Preventive Maintenance or Work Orders (if necessary).
Monitor compliance in Manufacturing, Packaging, Product Development/Technical Services (PDTS), and Warehouse areas.
Blend sampling (with exceptions).
Perform in-process checks and finish goods inspections to ensure product conforms batch record specifications.
Perform AQL Sampling.
Collect and submit Stability Samples from Manufacturing and Packaging operations.
Verify and confirm issuances and reconciliation of product and components.
Inspect and release printed packaging materials.
Revise SOP as needed
Initiate Change Controls
Write Protocols, CAPAS & Deviations as assigned
Handle various requests from departments for developmental or investigative reasons.
Master Label Creations
Provide support to complete Annual Product Review
Perform annual product visual inspections.

IPQA/ INSPECTOR

Confidential

Responsibilities:

Responsible for performing in-coming inspections of all raw material/components, performing in-process inspections, providing clearance for rooms/lines to run, and ensuring adherence to company standard operating procedures (SOPS), current good manufacturing practices (cGMP), and batch record specifications.
Identify, report and document Unplanned Deviations.
Perform, support, and document Planned Deviations.
Perform complaint sample inspection.
Performing in-process checks for tablet compression, encapsulation, liquid filling, granulation, final blend, and packaging lines.
Submitting the samples from in-process and finished products to the quality control lab and product development lab as per standard operating procedures of the company.
Identifying any non-conforming material and control the status of materials during incoming inspection.
Identifying any in-process failures during in-process inspections.
Providing support to the stability program by ensuring all rooms/lines meet requirements specified within procedures before use.
Following and adhering to all company and food and drug administration (FDA) guidelines, protocols, and standard operating procedures (SOPS)
Monitoring IPQA room clearance and minimize any delay for production areas.
Performing any other QA assigned duties.

PHARMA RECRUITER

Confidential

Responsibilities:

Recruiting life science professionals like drug safety associates, Pharmacovigilance, clinical research associate (CRA), the clinical data manager (CDM), clinical project managers, clinical business process analyst, regulatory affairs, medical device validation professionals, clinical SAS programmers, biostatisticians, statistical programmers, research associates and many other positions based on client requirements.
Batch production record issuing, retrieval & archiving
Checking the parameters during the processing at various stages of manufacturing as required in the batch production records.
Review of batch production records for batch release bulk drug product.
Control on master copies of standard operating procedure, batch production records, and other official documents
Handling of deviations in the drug manufacturing process

SOFTWARE TEST ENGINEER

Confidential

Responsibilities:

Analyzed system requirements, developed tests, writing test plans and test scripts for end-to-end testing based on Business Requirements, and interacting with the client.
Wrote test cases for manual and automation testing and tested applications manually and with automated tools.
Tested applications in different types of browser versions, such as Internet Explorer, Firefox, Google Chrome to simulate the production environment.
Performed manual and functional testing to test the functionality of the modules.
Performed functional decomposition of requirements for developing test cases.
Generated test cases and traced them to the relevant use cases.
Worked with users and business analysts to define and design test scenarios and test data.