JAYAPRAKASH PATEL

*** ********* **** *** # *-**

PARSIPPANY, NJ 07054

973-***-**** (H) 973-***-**** (C) ac0iso@r.postjobfree.com Summar y o f Qua l i f i c a t i on

Medical device and Pharmaceutical industrial Quality Assurance as well Manufacturing Packaging supervisory know-how, commitment towards teamwork, excellent customer service orientation skill to achieve company goals. Knowledge of numerous kind of sampling and inspection techniques, Versatile, dependable industrious Complaint Analyst,Senior Quality Assurance with 30 years’ involvement in the accustomed to working in a fast paced, demanding environment. Efficient to manage multiple assignments and swiftly mastering new responsibilities.

Emp l oyment h i s t ory

MAQUET [GETINGE Group]

45 Barbour Pond Drive, Wayne, NJ 07470 March 2016-March 2017 Product Complaint Analyst

• Product defect complaints determination, enters all complaints received in Track Wise, and escalates any Complaints Requiring Immediate Attention.

• Collecting follow up information related to complaints from customers. Typically through the Sales and /or Field Service groups.

• Gathers and reports various complaints metrics. Presents critical information at Complaint Reviews.

• Paying strict attention to detail, careful risk assessment, strong customer service, effective communication, and strong data entry.

• Timely intake of complaints and coordinating all parts of the intake process to ensure all needed information is collected at the first call.

• Investigation and documentation of field clinical events and follow-up with Sales Representatives.

• Work in a team environment with members of the QA-Product Surveillance group on achieving team metrics requirements.

• Maintains a record for each complaint received for all products, as required by FDA and MHRA regulations.

G&W Laboratories, Inc. June 2015-Dec 2015

111 Coolidge Street, South Plainfield. NJ 07080

Quality Operation Consultant

• Record and/or review data document notebooks, reports forms, system data updating activities in accordance with applicable guidelines, SOPs and Company policies.

• Responsible for the test results documentation verification and in-depth data review of raw materials, in-process, finished product, Control Retain samples, calibrations, stability, technical service-submission samples or projects within the QC Chemistry or Microbiology Laboratory, in a manner consistent with established standards.

• Daily support of the data integrity and GLP quality assurance program for Preclinical, Analytical chemistry, Material characterization program.

• Accustomed with basic computer skills including SAP/R3, TRACKWISE, CALS, LIMS, EDMS, ORACLE, Microsoft and Empower network Products.

PAR Pharmaceutical, Inc. Aug 2014 – May 2015

1 Ram ridge Road, Spring Valley. NY 10977

Sr. Quality Assurance Associate

• Perform manufacturing/packaging executed batch record stage review to completion of manufacturing and packaging operations in real time.

• Sampling/Inspection and release of incoming raw materials and packaging components/devices used in the manufacture/packaging of pharmaceutical products.

• Audit and monitor quality with respect to manufacturing, packaging, pharmacy, warehouse, and control Drug products in accordance with the company policies and specifications.

• Act as quality representative on the floor during manufacturing/packaging activities i.e. verification of line clearance, cleaning and start up activities and documentation/records during production/packaging operations, and perform in-process testing. HALO Pharmaceuticals, [Formerly ABBOTT, BASF, KNOLL Pharmaceut i cal s ] WHIPPANY, NJ 07981 Dec 1999- Dec 2013

Sr. Quality Assurance Associate

• Performs batch record review and approval based on product acceptance specifications

• Plays an active role in solving compliance errors when detected during the processes

• Enforcement of quality standards and process controls

• Evaluates and approves quality investigations and associated CAPAs; Involvement in critical quality investigations

• Assures that all Quality Events, Change Controls, CAPA's and/or any other required documentation related to the lots have been completed and closed before lot or material is released

• Places material on QA hold as needed when there are inaccuracies in the batch records or upon initiation of an investigation.

• Performed internal audits at manufacturing /processes/warehouse/retain sample staging area

• Communicates with contract customer regarding closure of investigations and batch release status, resolves questions regarding batch record documentation

• Performs daily monitoring of Mfg./Pack ./Product development operations with a focus of right at first time [Tablet, Capsule, Powder, Blister, Liquid, Ointment, Pouch, Aerosol,Gas and Hazmat]

• Create effective decisions in a timely manner and be focused on execution until completion

• Recognizes problems within scope of job promptly and clearly communicates them to the management

• Follows directions and demonstrates proper judgment when a deviation occurs

• Identify batch record documentation that fails to meet requirements

• Contribute to the resolution of problems relating to the quality of batch records by working with QA and Operations.

• Issue batch records to the manufacturing and finishing departments for production, which includes assignment of expiration and re-test dates to manufactured product upon issuance.

• Assign stability requirements as needed to manufactured product and raw material upon issuance to finishing.

• Sample, inspect & release all CDS and non-CDS drug substances including raw materials, work in process and finished goods

• Sample, inspect, test & release printed & non-printed commodities, e.g. bottles, caps, cotton, labels, leaflets, cartons, blister cards, shippers, films, foils, etc.

• Support Operations by monitoring and performing in-process inspection of Tablet, Liquid, Semi- solid & Blister operations

• Sample a variety of ancillary materials like purified water, clean steam, Nitrogen gas and alcohol

• Maintain both manual and electronic records of sampling, testing, inspection and release data

• Disposition of the incoming material for use in pharmaceutical manufacturing

• Participation in activities such as product/process improvement, troubleshooting, complaint handling, failure investigation, stability testing and CAPA documentation BL I SPAK INC, Nov1998-Nov1999

Whippany . NJ 07981

Qual i ty Cont rol Supervi sor

• Receive, quarantine & release bulk products and packaging components such as film, foil, inserts and cartons

• Prepare specification data sheets; produce master batch records and labels

• Reconcile batch records and release finished goods for shipment

• Handle QC retention sampling schedule, product complaints and annual review DURAMED PHARMACEUTICAL, Inc . Oct1997-Nov1998

Somerset, NJ 07873

Qual i ty Assurance Inspector

• Documentation review, prepare, and issue labels & shipper bar codes

• Sampled raw materials and packaging components

• Processed torque and leak testing during packaging and labeling run

• Thorough knowledge of Standard Operating Procedure and cGMP. SIDMAK LABORATORIES, Inc. Sep1992-Sep1997

Eas t Hanover, NJ 07936

Qual i ty Assurance Inspector

• Monitored and performed in-process testing on batches in the compression and encapsulation stages, tests include weight checks, disintegration, friability, hardness, thickness and moisture analysis

• Audited and approved work area and equipment as well as physical characteristic of the entire product

• Performed validation: Cleaned rooms, equipment, unit & large dosage of blends, compression as well finishing stages per established protocols

• Performed batch record review - inspection of finished product and AQL reports WOCKHARDT LABORATORIES Ltd. India Sep1985-Sep1991

Product ion Supervi sor

• Responsible for Dextrose derivative and protein extraction plant: Neutralization filtration, leaching, precipitation, decantation, entolation, formulation development and spray drying

• Developed excellent data analysis skills for preventive maintenance and Instrument calibration programs

Educat ion: -

• 1981 – Bachelors of Science [CHEMISTRY]; GUJARAT UNIVERSITY, INDIA

• 1983 – Bachelors of Education [Math & Science] GUJARAT UNIVERSITY, INDIA

• 1985 – Bachelors of LIBRARY & INFORMATION, Science’s UNIVERSITY

• 1998 – Certification - Instrumental Method of Analysis: HPLC, GC, UV, IR, LIMS,CCM, Randolph, NJ

• Pursue Associate in Computer Information System, County College of Morris, NJ

• 2014- Green Belt Six Sigma certification, County College of Morris, NJ Ref erences: - Furni shed upon request

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