QA Specialist

Amjad I. Saleem

***** ******** *** **. ******* NC 27614 919-***-**** *************@*****.***

Professional Summary

Strategically minded and result-driven Manufacturing and Quality Assurance Leader with 18 years’ experience in the biopharmaceutical manufacturing and pharmaceutical building construction industry. Recognized for effective leadership abilities with a proven record of exceeding standards and expectations. Demonstrated success in project-managing complex initiatives and strategic programs to drive continuous quality improvements through audits and risk-based decision-making. Comprehensive expertise in quality assurance, manufacturing, and ensuring compliance of Documentation & Records Management systems, and with local and federal regulations. Collaborative, influential, and able to work cross-functionally and inspire a diverse audience to achieve the company’s main goals and objectives. (Passion for zero error in process and product)

Education

NC State University @ Bionetwork- NC Community Colleges

Certificate, Aseptic Techniques, Cell Culture & Upstream Processing March 2019

Wake Technical Community College, Raleigh, NC

Certificate, Maintenance Technician April 2015

North Carolina Process Technician Board Raleigh, NC

Certificate, Process Technician CPT Dec.2015

Johnston Community College Smithfield, NC

Certificate, Advanced Bioprocessing Dec. 2015

Certificate, Biopharmaceutical Regulations Dec. 2015

Certificate, Aseptic Training and Elements of cGMP in Bio-manufacturing Processes Dec. 2015

Certificate, Bio-Work July. 2015

Asian Institute of Technology, Bangkok, Thailand

Master in Environment Management (course work Completed), 1995

University of Engineering & Technology Lahore, Pak

Bachelor’s in project planning Oct. 1986

Relevant Coursework

• Batch Record Issuance/ Approval • Environmental Health & Safety, Industrial Maintenance

• Pharmaceutical Quality Control and FDA Regulations, Validation/Protocol

Practical Training

•Environment Impact analysis• Six Sigma Yellow Belt• Audit • Industrial Safety and Technical documentation with Trouble shouting and Root Cause Analysis, Quality Assurance, Protocol

Professional Experience

Sr. Quality Assurance Manufacturing Specialist – Alcami Corporation Durham, N. C Sep 2022-Mar 2023

Implemented and maintained a quality system based on CFR (Code of Federal Regulation).

Supervised Quality Assurance Associates and Visual Inspectors

Prepared, printed, reviewed, and approved Batch Record / Guidelines of Quality Assurance

Archived Documents for Internal and FDA audit).

Actively participated Internal and FDA audits

Reviewed Specifications, Standard Test Methods (STMs) of Raw Materials, FP, Stability, Packaging materials, Test Data Sheets and Lab documentation

Reviewed Master Production Documents, Validation Master Documents Lab Documents and SAP master recipes for completeness and accuracy in accordance with standards and current GMPs.

Ensured that all changes to master production documents and master recipes have been implemented using an approved change control.

Ensured that Deviation Reports investigated properly and CAPA training completed.

Verified and approved the final product for release, after conformation/completion of Certificate of conformance, Reviewed BPR, Certificate of Analysis, Deviation Report, Change Control Report, Out of Specification Report (Lab Samples)

Performed Shop Floor QA activities in aseptic areas as daily task, (line clearance, AQL, visual inspection, approval of defect kits, review batch record and logbook during the batch running, and Safety walk)

Quality Assurance Specialist (Manufacturing) –Seqirus Holly Springs, N.C April 2017-Sep 2022

Reviewed production records for conformance to procedures.

Conducted non-conformance tests of manufactured, packaged or tested product.

Proficient on AQL

Performed Line Clearance after completion of each batch.

Conducted Weekly Quality self-inspection

Initiated and close Triage/DR and conducted CAPA and implement

Execute process steps to full-fill the task in Parts Washer, Autoclave, Filter Integrity Test, Parts Preparation and Assemblies, Vapro Osmometer, pH meter, SEBRA RF Tube Sealer, Wave Tube Sealer, Bench Top and Floor Scales, Terumo Tube Welder, Pall Kleenpak Connector, and Universal Small Volume Buffer (MF-59, Buffer M, 5X, 10X) according to defined SOP’s and BPR’s.

Interfacing with process automation systems and performed SIP(SOP), CIP (COP), Universal Vessel Pressure Test, Environmental Monitoring Surface Sampling, Environmental Monitoring and Decon of SKAN Filling isolator and Aseptic Interventions by using electronic business systems (e.g., LIMS, SAP, LiveLink, Delta V, Sharepoint, SuccessFactors, DEMS Trackwise,AX.)

Proficient on Final Packaging Process, Proficient on Front End Packaging, Proficient on Packaging Production Clearance, Proficient operator on these equipment, Cartoner, Brevetti Inspection machine, Denester, Labeler, Bundler and Casepacker and OPTEL Control.

Quality – Batch Review Specialist –Novartis Wilson, N.C Dec 2015 –Mar 2017

Made quality decisions (accepted or rejected) based on provided control outlines.

Reviewed production records for accuracy and compliance.

Performed routine quality inspection operations.

Maintained and organized all records, documentation, and other files associated with quality inspection tasks.

Quality Compliance Manager -Subway (Nisar Enterprises Inc.) Knightdale, N.C April 1999 --Aug. 2015

Managed work in process (WIP) for the Subway to ensure timely release of finished products which meet subway Headquarter and local health department requirements.

Released reports to Subway Headquarter, which has demonstrated compliance to Health Department requirements through review of safe handling of food.

Monitored auditing of completed all Subway stores records and specifications to assure timely release of reports which demonstrates compliance to Subway policies, procedures, specifications, and Health requirements.

Supervised food prep, while ensuring compliance with exacting standards of customer’s expectations.

GMP Project Manager – Planning Engineering & Architectural Concern (PEAC) PAK. Oct 1986 - 1999

Provided Planning, designing, construction services and project management for pharmaceutical company under the supervision of FDA and EPA - cGMP guidelines.

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