Quality Control Manager

Mayurkumar Patel

***, ********** ****, ***#** Phone: 408-***-**** Parsippany, NJ-07054 E-mail: f19rer@r.postjobfree.com

Objective:

• To secure a challenging and growth oriented position in pharmaceutical industry to utilize my knowledge in pharmaceutical science and clinical research.

Summary:

• Knowledge of FDA guidelines, process validation, cleaning validation, 21 CFR part 820, 21 CFR Part 11(computer system validation), ICH Q7 and ICH Q8.

• Academic level knowledge of instrument Installation Qualification (IQ), Operational Qualification (IQ), Operational Qualification (OQ), performance /process Qualification (PQ) protocols.

• GXP qualities, management skills, assiduous, ability to implement the CAPA process as per SOPs.

• Working experience of cGMP (USP, ICH, CFR) and GLP environment.

• Experience in writing and maintaining batch record, SOPs and report submission.

• Strong technical knowledge and adaptability with good communication skills.

• Leadership, Quick Learner, Multi-tasker, and flexible with time schedule.

Skills:

• Laboratory: HPLC, TLC, GC, Colorimetry, Flame Photometry, UV & IR Spectroscopy, Calibration of Instruments, Lab scale tablet manufacturing.

• Software: Microsoft Office (word, power point, excel, project, Visio).

• Technical Writing: Knowledge of writing SOPs, URS, Protocols.

Lab Experience:

• Application of Physical chemistry, Organic chemistry, and material science in formulation development during course work.

• Expertise in Chromatography techniques: TLC, HPLC, GC.

• Familiar with lab techniques: Dissolution, Disintegration, Impurity assay related to Tablets & Capsules, Spectrophotometry.

• Excellency in Titrimetric analysis, Extraction, Cleaning techniques, and Assays, Wet Chemistry.

• Loss on Drying, Calibration of instruments, microscopy, calorimetry.

• Hands on experience on Hot air oven, Autoclave, Viscometer, and equipment typically found in formulation labs.

• Lab working experience in formulating Topical products.

• Lab working experience in formulation of different cosmetics (skin care, hair care products).

• Experience in formulation of emulsions, suspensions, use of different surfactants, liquid materials.

• Batch Production techniques: Mixing, Blending, Drying, Punching, Coating of dosage forms.

Professional Experience:

Vital Formulations Ltd., v.u.nagar, India

Assistant Production Trainee May 2009 – Dec. 2009

- Supervised Compression and Coating of tablets as per BMR (Batch Manufacturing Record) and following the SOPs.

- Conducted experiments to produce in-process data along with batch production such as dissolution, disintegration, friability, and hardness.

- Method development and writing product specifications and SOPs.

Atul Limited., Ankleshwar, Gujarat., India

Assistant Quality Control Chemist April 2008 – Dec. 2008

- Performed instrument calibration and preventive maintenance for analytical instruments.

- Performed qualitative and quantitative analysis of raw material (chemicals) and drug substances with GLP compliance.

- Solution preparation and extraction of pharmaceutical products for analysis.

- Performed quality tests using HPLC and GC following SOPs ensuring compliance.

- Data interpretation, writing analytical reports and report submission to QC manager.

Education:

New Jersey Institute of Technology, New Jersey Jan. 2010 – Dec. 2011

Master’s in Pharmaceutical Engineering GPA: 3.8/4.0

Coursework till date:

- Validation and regulatory issues in pharmaceutical industry; Pharmaceutical reaction engineering; Pharmaceutical project Management, Total quality Management, Pharmaceutical unit operations: solid processing, liquid and dispersion systems; Principles of pharmacokinetics and drug delivery; Pharmaceutical packaging technology; Principles of pharmaceutical engineering; Pharmaceutical facility design.

Bachelor of Pharmacy

L.B.Rao Institute of Pharmaceutical Education &Research, Sep. 2005 –may. 2009 Khambhat, Gujarat University, India. GPA:3.85/4.0

Achievement:

- Have qualified GATE (Graduate Aptitude Technical Examination) 2009 with 90.02 percentile.

Presentation:

Pharmaceutical Unit Operation- Particle size reduction

- Addressed a seminar presentation, as a part of course work under guidance of Prof. Boris Khusid, on different methods used to reduce the particle size and different factors that should be taken into consideration that affect the particle size reduction.

Clean in place (CIP) and sterilization in place (SIP)

- Addressed a seminar presentation, as a part of course work under guidance of Prof. Frank DeRosa and Prof. Norman Goldschmidt, on principle and importance of CIP and SIP as a reliable and repeatable process that meets the stringent hygiene regulations demanded by the food, dairy, biotechnology and pharmaceutical industries.

Novel Drug Delivery System- Needle Free Injection.

- Addressed a seminar presentation, as a part of course work under guidance of Prof. Stephen T. Orosz, on the design, manufacturing, assembling and packaging of needle free injection.

References: Available upon request.

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