Manufacturing Manager

Syed Iqbal

Freehold, NJ *****

*******@*****.*** - 1-732-***-****

SUMMARY OF QUALIFICATIONS

** ***** ** ********** ** biological and pharmaceutical operations

Train, coordinate, plan, self motivated and focus team player, inventory control, excellent time management, self-learn skill, multi-task, prioritization, and supervise

Investigate customer complaints

Knowledge of Documentation, FDA, DEA, SOP, GMP & CGMP, Quality system manual, worldwide Quality policy, Global Health, safety and environmental regulations pertaining to pharmaceuticals and bio medical devices operations

PROFESSIONAL EXPERIENCE

Ortho Clinical Diagnostics (OCD) Raritan, NJ 08/2017- Present

Quality Control Inspector

Inspect incoming raw material, component

Use of sampling plans

Certified component reduced testing/inspection

Nonconformance recording and tracking

Placement of material Approved, Conditional release, Hold and Reject

Material and Component Batch record review, and disposition

Performs appropriate material controls in accordance with current procedures and specifications

Maintains good communication with manager and team

Ability to schedule work load to meet department and team goals with minimum supervision

Ability to detect and resolve errors and discrepancies

Maintain data Incoming Daily-Weekly Log

Use Allen-Bradley system for material measurement

Use calibrated caliper and gage for measurement

RCA Inc. - Dayton, NJ 01/ 2017-03/ 2017

QA Documentation

Perform final documented review of completed batch paperwork.

Documentation responsibilities include the Critical Systems documentation.

Provide support to management during all regulatory inspections.

Bio-pharm Inc - Levittown, PA

QA Inspector (Incoming) 08/ 2015- 10/ 2016

Ensures compliance with cGMPs, Company SOPs, FDA, and DEA requirements during all Phases of operations.

Ensures the raw materials, components, and labeling materials have been received from the approved vendor.

Inspects incoming raw materials, components, and labeling materials to ensure compliance with the approved specifications, certificate of analysis and labeling requirements.

Samples raw materials, components, and labeling material as per the approved procedures and sampling methodology

Submits samples to the QC laboratories and follows-up the status of the submitted samples

Reviews and verifies labeling text to ensure compliance with the approved master

Performs component testing as required per the SOPs

Ensure proper handling and storage of all incoming materials to designated areas in QA and manufacturing warehouse

Ensures that all materials have been appropriately labeled as Released, Quarantine etc. and stored as per the SOPs and manufacturer instructions

Maintains label control, and controlled substances in warehouse

Verifies reconciliation of labeling materials

Maintains QA sampling booth

Updates and maintains all documents related to receipt, handling, sampling, storage, and testing of incoming materials using electronic and paper documentation systems as per the SOPs

Maintains current approved vendor list and masters of labeling

Works closely with warehousing for material movements in and out of warehouse

Conducts daily walk-through of the warehouse

Works closely with manufacturing, and supply chain /purchasing departments to resolve issues related to incoming materials

Assist in performing Internal Audits

Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations.

Assists QA Manager in any other QA duties assigned to maintain the work flow of QA departments

Tris Pharma - Monmouth Junction, NJ

Production Tech 09/2012 - 08/ 2015

Position: Production Tech

Full knowledge of manufacturing and Federal regulations pertaining to manufacturing processes.

Manufacturing and compounding of liquids products. Charging and handling of raw materials into compounders, pre-mixers and transfer tanks.

Verifying that all equipment is calibrated as per SOP and GMP procedures. Operating manufacturing equipment per Sops. Ensure compliance to GMPs. Break down, clean and reassemble different machines such as; High Shear Mixer, Agitator Filter Dryer, Transfer Pumps, V-Blenders, Fitz Mill, Co Mill and Tray Dryers. Maintaining a safe work environment.

Aurolife Pharma

Operator in Granulation and Blending 06/2009 - 09/2012

Followed SOPs for operating and cleaning equipment used in the production of oral solid dosage

Blended and granulations in accordance with SOPs and manufacturing Batch Record.

Measured and examined product to confirm conformance to manufacturing Batch Record's specifications.

Record keep and reconciling of Granulation and Blending related documents.

Coordinate with production and planning for job related activities. Adhere to the safety and health program and associated plans. Controlled substances experience

OHM Lab

Operator in Granulation and Blending/packaging 10/2006 - 05 2009

Ability to read and understand Batch Record.

Blended and granulations in accordance with SOPs and manufacturing Batch Record.

Measured and examined product to confirm conformance to manufacturing Batch Record specifications

Reconciling of Blending and Granulation related documents.

Qualifications:

Intermediate ( HighSchool ) from U.P. India.

Certificates from Middlesex county vocational Technical school in

East Brunswick from Sep. 2008 - 09 :-

Electrical Trades Circuits Residential Wiring to NEC Code

Electrical Trades Circuits: Shop Practice

Programmable Controllers - Allen Bradley

References:

Available upon request

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