NIRANJANA RANA

** ********* ****

East Windsor, NJ 08520

EMAIL:-advh4b@r.postjobfree.com

Phone # 609-***-****

OBJECTIVE

Seeking a career opportunity where I can utilize my experience and trainings as decrial position. EDUCATION

1983-1984

M.S.University of Baroda

Baroda, Gujarat, India

Master of Commerce in Accounting & Auditing, Banking 1985-1986

M.S.University of Baroda

Baroda, Gujarat, India

Bachelors in Education in Accounting & Auditing, Economic 1986-1987

Fortune Info Technical Institute Baroda, Gujarat, India Medical Transcription

EXPERIENCE: -

Berry Global Inc.

Mar-2020- Present

Position: Quality Assurance Technician

Responsibilities:

• Monitor and verify product for defects per standard operating procedures and ensure compliance to all GMP, SQF and product safety practices.

• Maintain accurate recordkeeping on all quality reports per standard operating procedures.

• Monitor inspection of packing process.

• Perform sampling and testing of products in accordance with quality standards that are traceable to accredited methods.

• Know the basic functions and how to operate the following test equipment: Air Gauges, Function Fit Gauges, Plug Gauges, Calipers, Micrometers.

• Visual and dimensional inspection of our product during our Injection Molding process to ensure our product is per customer specification using SQF and ISO Guidelines and procedures.

Appco Pharma

Nov-2017-Mar 2020

Position: In Process QA Associate

Responsibilities:

• Collection and maintenance of Incoming materials, in process samples, finished products & stability samples and submission to quality control.

• Issue of inventory cards for incoming materials and affixing of status label for all the materials.

• Assigning of batch number for submission batches and commercial batches.

• Issue of batch numbers for submission batches and commercial batches.

• Equipment Area/room and line clearances for manufacturing/packaging.

• In-process quality assurance checks including environmental conditions during manufacturing and packaging.

• Requisition and submission of different manufacturing stages of samples to Quality control (in- coming materials, in process, finished products, stability samples, others if any).

• Monitoring of submission and commercial batches.

• Giving the line clearance for usage of equipment’s rooms for manufacturing and packaging.

• Collection and maintenance of reserve samples.

• Assigning of incident report numbers, deviation numbers, out of specification numbers, equipment ID numbers, and material codes etc.

• Issuing of control copies of master documents and logbooks to user departments.

• Collection and maintenance of stability samples and execution of stability protocols.

• Monitoring of stability chambers.

• Maintenance of documentation as needed.

• Follow current good manufacturing practices and good documentation practices.

• Follow in house safety rules.

• Review technical documents like batch records, protocols and reports etc.

• Ability to use functional & dimensional test method of capsules & tablets for using caliper, micrometer, hardness, thickness, friability & deviational. Packaging Coordinator Inc. (PCI)

May 2015-Nov 2017

Position: Quality Assurance-Inspector

Responsibilities: -

• Responsible for ensuring that Standard Operating Procedures are consistently followed and that cGMP’s are observed, in the course of packaging operations.

• Verifying and reconciling materials to and from Clinical Production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies.

• Inspect and release all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents all activities accordingly in the associated logbook.

• Supports and assists Mechanics on the execution of Operational Verifications (OVs) and Set-Up Records (SURs) both prior to the start and during the process (if necessary) for any jobs using validated or non-validated equipment respectively.

• Reviewing and understanding both the Production Protocol and QA Protocol prior to starting the Clinical Packaging process.

• Performing and documents hourly QA Inspections on assigned clinical packaging rooms as per both the QA Protocol and SOPs requirements as well as ensuring that the Production Protocol and GMP standards are being followed.

• Reviewing the batch record and any associated paperwork for any documentation errors made during the clinical packing operation and again when the job is completed prior to submitting the batch record to document control.

• Reviewing EMS system printouts for out of specification temperatures, humidity and pressures.

• Printing and reviewing Material Usage Reports for each clinical packaging job and/or operation to ensure that the drug product quantities documented in the batch record match those that are entered in the Inventory Management System.

• Ensuring that all Inventory Management System printed labels are correct against the information provided in the associated protocol.

• Updating the daily/shift QA turnover log with all pertinent information regarding activities during the assigned rooms and shifts and forwards relevant notes via email to all pertinent employees.

• Performing walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMPs are being followed.

• Review production logbooks for GMP compliance as each operation is completed and revises SOPs as needed.

• Partnering with other departments in resolving unplanned deviations, investigations and in troubleshooting. Driving deviations and investigations to completion.

• Performing additional sampling/testing protocols on clinical trial materials as requested by the customer.

• Performing equipment parts inspection, approval and storage as required per SOPs.

• Inspecting and verifying that all clean storage rooms meet approval criteria as per our SOPs.

• Participating in customer audits when required.

• Substituting for Quality Lead Inspector when necessary more then 15 people.

• Ability to communicate with other shift leads to determine work load & needs.

• Report & issue or problem with employee or equipment.

• Performing other duties or tasks as requested or required by QA Management.

• I have experience writing certification of analysis & issue batch record. Shiseido

East Windsor, NJ

February 2013-March 2015

Position: Quality Incoming Inspector

Responsibilities: -

• Perform component, in-process and end of line inspections/audits in accordance with SOPs for inspection guidelines. Assure all product meet specifications (aesthetic, fit, form, color, order, appearance) as defined by SOPs, packaging engineering specs, AQL and visual standards. Apply visual and functional test methods as required.

• Audit production lines using Inspection Checklist to document and record key product parameters such as batch/lot codes, fill weights, etc.

• Perform pallet inspections, which requires lifting and opening of totes (35lbs), packers and folding cartons in accordance with AQL sampling guidelines

• Complete required QC inspection records using proper English in clear legible handwriting which conforms to all internal and external (GMP/FDA) requirements

• Conduct and evaluate physical inspections utilizing established test methods, comparing results to approved specification, perform dimensional and functional evaluations utilizing caliper, micrometer, Vernier’s, thickness and force gauges. Conduct release torquer and vacuum/leakage test, and fill weight evaluation & ability to read blue print.

• Perform quality status maintenance with MAPICS computer system. Ensure that all inspection, testing and audit documentation are accurate, current and systematically stored. Issue inspection/audit dispositions (accept/reject) and affix appropriate accept/reject stickers on the goods.

• Maintaining conformance to established SAI/Customer quality stands, GMP, FDA and OSHA compliance

• Perform component and finished good audits to resolve customer and/or production quality issues. Assisting with establishing reworking standard

• Completing all the other tasks as directed by the QC-supervisor INTERNATIONAL VITAMINS COMPANY

June 2009-December 2012

Position: QUALITY CONTROL INSPECTOR

REPONSIBILITIES: -

• Quality Checking area & equipment cleanliness & give line clearance for packing operation.

• Approved the room clearance & equipment clearance based on SOP, GMP, cGMP for complete cleaning or partials cleaning for start up on every new batch.

• Check the fill volume, capping, labeling and chip box packing operation.

• Maintain the quality level for the packaging line.

• Maintain the quality of products based on requirements.

• Prepared product labels, Inserts, outsets and master shipper labels as required by the document control and packing lines.

• Review of Batch Manufacturing Record.

• Verifying the finished product stocks and releasing it.

• Measure and calibrations of packaging component& testing of labels, Inserts of packing lines.

• Reconciliation of packaging master record &percentage.

• To verify the stocks &endorse on the finished goods notes. Accumed Inc, Lawrence, NJ

2005 to 2009

Position: Quality Assurance Associate

RESPONSIBILITIES: -

• Checking area & equipment cleanliness & give line clearance for packing operation.

• Approved the room clearance & equipment clearance based on SOP, GMP, cGMP for complete cleaning or partials cleaning for start up on every new batch.

• Check the fill volume, capping, labeling and chip box packing operation.

• Maintain the quality level for the packaging line.

• Maintain the quality of products based on requirements.

• Prepared product labels, Inserts, outsets and master shipper labels as required by the document control and packing lines.

• Marinating stability for all the validations products.

• Monitoring & co-coordinating all quality assurance activities.

• Reconciliation of labels chip boxes & inserts after packing order has been completed & find out final output, the yield, percentage of product. Medico Lab Inc, Hamilton, NJ

2003 to 2005

Position: Quality assurance Associate

RESPONSIBILITIES: -

• Ensuring the products are manufactured taking into account the requirements of good manufacturing practices.

• Review of Batch Manufacturing Record.

• Verifying the finished product stocks and releasing it.

• Measure and calibrations of packaging component& testing of labels, Inserts of packing lines.

• Reconciliation of packaging master record &percentage.

• To verify the stocks &endorse on the finished goods notes.

• Took inventory for all labels & inserts control and non controlled drug on quarterly & yearly basis.

• Conducting quality audits to appraise the offensiveness of quality assurance system.

• To develop implement & maintain system to insure customer quality stands &regulations.

• Performs weekly water testing.

• Performs releases of finished goods from warehouse. Maintains calibrations of analytical equipment.

• The in process quality assurance for pharmaceutical manufacturing.

• Weighing of liquids, tablets and capsules, poweder, gel according to applicable SOPs.

• Performs room/line clearance for the manufacturing and packaging areas according to applicable SOPs.

• Performs in-process audit for the manufacturing and packaging areas according to applicable SOPs and other controlled documents such as batch records and protocols.

• Checking all log books like manufacturing area, dispensing material area and all lines log-book.

• Check and verifying temperature in manufacturing area; record in log-book.

• Ensuring proper operating of documents and records tracking as per GMP.

• Responsibility of initiating change of procedures and write new procedures.

• Have excellent documentation skill and ability to maintain accurate records. TECHNICAL SKILLS

Proficient in Microsoft office, COBOL, Computer Programming &Typing (80 w.p.m). OTHER SKILLS

Detail ordinated, Multi-tasking

Ability to work as team

Excellent interpersonal and communication skills

Leadership skills

Extremely energetic and organized.

Reference provided upon request.

Contact this candidate