Quality Assurance Manufacturing
Resume:
SANJAYKUMAR N PATEL
Landisville, PA 17538
Contact No. 610-***-****
E mail ID: ********@*****.***
OBJECTIVE:
Seeking a challenging and responsible for Quality Assurance position where my expertise in documentation, IPQC, validation, audit will be utilized.
WORK EXPERIENCE AND JOB RESPONSIBILITIES:
1.GlaxoSmithKline, Marietta, PA (Sep. 2013 to till date)
Designation: QA Operation Specialist
Room clearance and release for the production batches.
Review and approve executed batch records. (Vaccine Filling, Lyophilization)
On floor coverage to support production.
Review and approve quality system documents i.e. deviation, CAPA, change control etc.
Lead investigators for investigating deviations and non-conformance.
Review and approve SOP’s, master batch records.
Author for SOP, CAPA, deviations and change controls.
Review and approve support documents i.e. Autoclave runs, Vessels CIP and SIP, Lyophilizer CIP, SIP, vial stoppers preparation and sterilization records etc.
Assist operation and participate for return to service of area, utilities and equipments.
Train and coach operational personnel for Good documentation practices, aseptic behaviors, critical alarm assessments, batch record comment recording etc.
Conducting GEMBA and walk troughs on operation shop floor.
Participate in internal and external audits.
2.Merck & Co. West Point, PA (July 2012 to Sep. 2013)
Designation: Ass. Quality Specialist
To perform batch record review. ( Vaccine lyopholization and inspection)
To perform real time batch record review on production floor.
Review Environmental monitoring data.
Review log books and cleaning logs.
Experience for sterile gowning ( Qualified RODAC test)
Trackwise experience for batch record review.
SAP experience for batch record review.
GMP walks to ensure all activities are according to SOP and with compliance.
Merck Yellow belt certification.
3.Sharp Corporation, Allentown, PA ( July – 2011 to July 2012)
Designation: QA Inspector
To perform daily IPQC at different stages of production (packaging)
Verification of cleaning of production area and proper documentation of cleaning logs.
Issuance of batch record for production.
Verification all components for packaging with batch record.
Assist production to ensure proper documentation for batch record and batch related documents.
To perform and verify equipment challenges.
Sampling of samples i.e. retain samples, line reference samples etc.
Investigation of any product related non conformance.
Identified root cause of non conformance and implement corrective and preventive actions.
Ensures that SOP’s is followed during operation to meet GMP.
Assist validation department during validation studies.
Review batch record for completeness and correctness.
Resolve discrepancies related to batch record with production department.
To print and verify shipper labels for the production.
4.Aventis Pharma Limited, Ankleshwar, INDIA: (November 2008-July – 2010)
(A Sanofi Aventis Group)
Designation: Executive – Quality Assurance
To perform daily IPQC at different stages of production i.e. manufacturing and packaging.
To ensure line clearance at different stages of manufacturing.
Preparation, Execution and Review of Process Validation Protocols.
Assisting in process validation and Cleaning Validation Program.
Handling of Deviations for planned and unplanned activities of production.
Handling of Change Controls, Market Complaint.
Investigation for deviations, Out Of Specification, Failure Investigations, NCRs.
Co-ordinate to conduct Self Inspection.
Auditing of Batch Manufacturing Records and Batch Packaging Records.
To carry out the Trend Analysis of Finished Product and Annual Product Review.
Release of Finished Products in SAP System.
Review of Hold Time Study Protocols of Products (stage wise) as well as Cleaned Equipments and Uncleaned Equipments.
To develop and train subordinates and trainees to achieve desired performance levels.
5. Lyka Labs Limited, Ankleshwar, INDIA: (July 2008 to October 2008)
Designation: Jr. Executive – Quality Assurance
To carry out in process quality control of finished products.
To ensure Line clearance at different stages of manufacturing (For dry powder injectable, external preparations and bulk sterile products)
To perform analysis of purified water and WFI.
Daily calibration of analytical instruments ( pH meter, Karl Fischer apparatus etc.)
To Prepare and Review of standard operating procedure and its distribution.
To prepare and review of analytical test reports.
Review of batch records.
Analysis of Raw material (API’s and Excipients) and finished products.
Handling of Failure, deviation, change control and OOS and its investigation.
Handling of complaints and its investigation.
Media fill validation for sterile products.
Batch release for market distribution.
Arrange stability schedule and prepare stability reports.
Arrange training programme for new recruited employees.
ACADEMIC CREDENTIALS:
1August - 2006 to May–2008
Master of Pharmacy
Institution: Faculty of Engineering & Technology,
University: Annamalai University, Annamalai Nagar, (T.N.). INDIA
Area of Specialization: Quality Assurance
2July-2002 to July-2006
Bachelor of Pharmacy
Institution: R.D. College of Pharmacy, Bhor, (Pune)
University: Pune University, Pune, INDIA
REFERENCE:
Available upon request.
Contact this candidate