Overall Summary:

A well professional QA personnel having about 7 years of work experience in different areas of Quality Operation in a world leading multinational pharmaceutical company including other local companies. During my career I have experienced 2 corporate GMP audits one time become auditee against cross functional audit and represent QO in company EHS and GMP related meetings. Although I have very strong command over all aspect of QA yet I believe in continuous learning and helping my colleagues to explore a new dimension of quality every day.

Personal Profile:

Name : Yasir Sultan

Marital Status: Married

Nationality: Pakistani

House No.1, Block 96, 5-G New Karachi, Karachi

Mobile: + (92-346-*******

acsy5t@r.postjobfree.com

OBJECTIVE:

To work in a challenging environment and hence my skills and knowledge could utilized for better performance.

EDUCATION:

2008 University of Karachi, Karachi

M.Sc First Division (Analytical Chemistry) (70% Marks)

2005 Islamia Science College, Karachi

B. Sc (Pass.) Second Division

2003 Government Science College Liaquatabad, Karachi

H.S.C Grade B

2001 Town Committee School, Karachi

S. S. C Grade C

WORKING EXPERIENCE:

Feb 2nd, 2009 to March 30th, 2010 as CHEMIST AM II in Quality Control Laboratory of Habib Oil Mills.

April 1st, 2010 to 18th of June 2012 as Quality Assurance Officer in Asian Continental Pvt. Ltd.

June 20th, 2012 to Date as QA Executive in Reckitt Benckiser Ltd.

TECHNIQUES AND INSTRUMENTS:

HPLC

Spectrophotometer

Flourimeter

Refractometer

Flame Photometer

Conductometer

PRINCIPAL DUTIES & RESPONSIBILITIES:

In-Process Control Tests of Oral Tablets & Capsules, Oral Liquid & Suspension, Sterile Injections & Packaging.

GMP Compliance checks according to RB Manual, MOH, WHO, and CFR (Sterile and Non – Sterile Area) applied at RB.

Deviation and Change Management, handling, investigation, Root cause determination and proper CAPA management.

Risk Management and Risk assessment using FMEA tools on Track Wise-8 software.

Market Return and Market Complaint handling and root cause determination and their CAPA management to avoid reoccurrence & Occurrence.

SOP Preparation, distribution and replaced SOPs obsceletion according to QMS and national legislation and their record keeping.

Annual Product Review and CAPA for Continual improvement from the outcome of APR, CI included market return, market complaints, Deviations, Audit & Inspections outcome & Risk management review.

Batch Document Review and Batch Release in JDE software on timely basis to avoid back orders.

Self-Inspection as well as Internal Audits according to Applicable regulations and Company’s internal requirements.

An External Audit of Al-Rahim Print and Packages conducted.

Management of Reference room, removal of all expired + 1 year products and batch cards, managing their incineration and certificate recording.

Prepared 03 BPR of Disprol suspension 90mL strength (New strength), Disprol p/s and for Gaviscon Liquid 240mL strength and implemented them.

Lead a team of maximum 06 QAI in the absence of Senior Executive, AM, and Manager at a time for One year in Reckitt & Benckiser.

Conducted R.O. and Boiler inspections

Optical Inspections in Injections

BET and TOC testing of water for Injection on Daily basis

Microbial Testing of Finished Product, Raw Material and Stability Products on routine basis.

Water Sample collection from initial point to point of use location of whole water network and its Microbial Testing of Complete Water Treatment Plant on weekly basis

Sterility Testing of Finished Injections on daily basis.

Sterile Area Environmental Monitoring

o Settle Plate Exposure

o Air sampling (Slit Air Sampler)

o Surface Monitoring (By swab technique)

o Viable or Non Viable Particle Count

Assisted Micro Department in Media fill trial of Ampoule filling machine and their Micro test results assessment.

Performed Process Validation of 14 products including Process Capability (Cpk and Ppk calculations and X bar R bar graphs)

o Prospective Validation

o Concurrent Validation

o Retrospective Validation

o Re-Validation

Cleaning Validation

Performed Equipment Qualification as per below sequence

o DQ (Design Qualification)

o IQ (Installation Qualification)

o OQ (Operational Qualification)

o PQ (Performance Qualification)

Got an additional responsibility for LOTO and worked for it under supervision of engineering manager.

Took part in EHS meetings to comply RB standards and took trainings of all EHS standards

Eight Coast Saving proposals given to QAM from which three were appreciated by QAM but could not implemented due to some management reasons.

Stationary items management and dealing with suppliers for asking quotations and purchasing.

OPERATIONAL EXCELLENCE PROJECTS:

Disprin Tablets and Disprol Tablets Bulk and FG Hold Time Study.

Cost Saving proposals to reduce costs.

Implementation of TrackWise-8 Deviation project through Pakistan (Mauripur).

Implementation of TrackWise-8 Risk Management project through Pakistan (Mauripur).

Introduction & Implementation of Risk Assessment in RB Mauripur factory.

EQIPMENTS OPERATIONAL & MANUFACTURING SKILLS:

Operation of Grall mixer.

Operationa of Ink Jet Printer

Operation of Ribbon Blender

Operation of Fluid Bed Dryer

Operation of Compression machines BB4-1, BB4-2

Operation of Blister Machine

Operation of Compact Bottle blowing, Filling, Capping, Labelling & Printing, and Cartoning Machine used for liquid filling.

Certifications: (internal & External)

Awareness and Internal Audit to IMS from SGS.

Information Security Awareness from Reckitt & Benckiser (Pvt), Ltd.

Business Management Systems

Compliance Passport

Computer System Validation (CSV)

Deviation Management through TrackWise software.

Health care technology Transfer

Good Distribution process

Hygiene design

Hygiene GMP/GHP

Hygiene HACCP (A risk assessment tool)

Hygiene Microbiology

Hygiene Process Management

Hygiene Plant

Quality, mission, vision and Principle

Safety & 5S in Laboratory.

COMPUTER SKILLS:

MS Office.

Reference:

Available on request.

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