Quality Assurance High School

Dipak Patel

** ***** ****, ******, ** *****

acxika@r.postjobfree.com Phone: 848-***-****

Objective

A challenging and performance oriented position as Quality Assurance with a reputed Pharmaceutical Organization.

Summary

Expertise in Quality Assurance field in pharmaceutical industries with more than 14 years of experience.

Able to handle and complete multiple tasks at once under pressure, projects without compromising time lines, quality, and functionally.

Computer literate in Word, Excel, LIMS, Oracle.

Energetic organized, self-motivated, a quick learner with good communication skills.

Have an ability to work for long time with the same concentration, accuracy and patience.

Training of new-hire with the effective way of maintaining quality. Professional Work experience:

Senior Quality Assurance 2011 - Present

Aurolife Pharma LLC, Dayton, NJ

Verify dispensing activity and review of pharmacy stage. Logbook review of various Manufacturing areas and equipment.

Working under strict cGMP regulations, responsibilities were Approval of line clearances for manufacturing and Packaging.

Performed in process testing at regular time intervals such as weight variation, thickness, Hardness, friability during Compression and Encapsulation. Verified printing material, labeling numbering, coding and cartoning during packaging.

Participated in Stability / Process Validation & commercial batch sampling during blending, compression, encapsulation, coating & packaging.

Balance Calibration.

Reviewed and approved work order.

Sampling from Blend, coating, compression, Encapsulation. Followed sampling plan and Performed AQL Inspection of finished product. Performed AQL inspection for special project and In-coming finished product.

Performed Cleaning Validation or Verification swab sampling and submitting to QC Lab.

Approved printed packaging materials.

Disposal of QA retain samples.

Experienced in Handling of controlled substances from Vault and cage and maintaining proper documentation.

Thorough understanding of GMP guidelines, QA documentation, Planned and unplanned Deviation and SOPs with respect to company.

Annual Product Review data entry.

Final review and released Batch Record of Manufacturing and Packaging. QA Inspector 2002 - 2011

NBTY Inc., South Plainfield, NJ

Verify dispensing activity and review of pharmacy stage.

Verify the cleanliness of the room and equipment in Manufacturing and Packaging area.

In process checks for Manufacturing and Packaging.

AQL - visual inspection for finished product and collect samples for QC testing.

Finished products check visually such as bottle, cap, label, seal.

Maintain work environment as per FDA regulation.

Logbook review of various Manufacturing areas and equipments.

Disposal of QA retain samples.

Inspection and approval and of printed packaging material and bulk packaging material for internal and contract manufacturing organization.

Education:

Bachelor of Science

Ahmadabad College, Ahmadabad Gujarat INDIA

Diploma in Ophthalmic Technology

Medical Collage, Surat, Gujarat, INDIA

High School Diploma

Tutorial High School, Ahmadabad, Gujarat, INDIA

1987

1984

1982

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