Quality Assurance officer

Maria Bangash

Marital status: Married

Mobile. 009***********

E-Mail: *****.********@*****.***

CAREER OBJECTIVE

To secure and establish a position in an organization where I can utilize my expertise and professional skills/ intelligence to brighten up my career and the organization.

PRESENT EXPERIENCE: (OCT 2011- TILL PRESENT)

POSITION: QA INSPECTOR

ESSENTIAL DUTIES AND RESPONSIBILITIES:

GULF PHARMACEUTICAL INDUSTRIES- JULPHAR – UAE (2011 Oct - Present)

Maintain cGMP compliance with all company policies and procedures

Perform Line Clearance / Inspections of the manufacturing facilities

Responsible to monitor the cGMP and cGDP implementation in the production/ QC and stores areas

Inspection of the documentation compliance in printing, packaging, manufacturing and weighing areas which includes checking of logbooks related to equipment usage/calibration/ SOP reading/ cleaning records)

Performing (FREEZERS/ REFRIGERATORS/ INCUBATORS Validation ) Qualification/ Requalification activities

Process validation.

Preparations of Validation Reports and assist supervisors in the validation activities.

Authorized to stop the manufacturing if the corrective action is not being taken after agreed decision with quality assurance manager with the relevant dept.

Preparation of Key process indicator (KPI).

Preparing Annual product Review (APR) reports

Review/ checking / Issuance of batch manufacturing records.

Performing Environmental Monitoring

Compilation / Review of Environmental Monitoring / Water Testing Trends.

Performing other responsibilities as well if assigned by Quality Assurance Manager or Quality Assurance Director

Responsible for giving SOP Trainings/ Evaluation

Preparation of QA related SOPs

Performing internal audits in assistance with the supervisors

PREVIOUS EXPERIENCE: - (JAN 2010 – SEP 2011)

POSITION:QC ANALYST

ESSENTIAL DUTIES AND RESPONSIBILITIES:

PFIZER GLOBAL MANUFACTURING/SUPPLY – PAKISTAN (2010 Jan – 2011 Sep)

To handle sophisticated instruments (HPLC/ FTIR / A.A .S/ G.C / TOC / Dissolution / Disintegration etc.)

To sample, inspect and analyze raw material, bulk, in process material, packaging material and finished products and stability samples.

Perform routine sample preparation and analysis with instruments (HPLC/ FTIR / A.A.S/ G.C / U.V etc.)

To perform method validation

Responsible for instruments calibration including glassware.

Preparation of stock solutions/ standard solutions/ calibration solution

Proper documentation as per cGDP/ to maintain Good housekeeping of the lab.

To keep a record of stock of chemicals and glassware and order as when required

Daily monitoring of reference standards/ pH buffers

Monitoring of reference sample / retention samples room/ stability chambers

Performed laboratory investigation in response to Out of specification / apparent failure or questionable results.

Comparative studies for same products

Follow SOPs during work; data management and maintenance to ensure compliance for audit preparation

Worked on lean lab.

Preparation of analysis report through the LIMS software

Maintaining lab logbooks

Worked on time and cost saving by reducing the testing methods mentioned in the lab monographs

TRAININGS/ CERTIFICATION: -

-GDP (good documentation practices) (Gulf Pharmaceutical Industries – UAE)

-cGMP (good manufacturing practices) (Gulf Pharmaceutical Industries – UAE)

-GXP(Gulf Pharmaceutical Industries – UAE)

-SIX SIGMA(Yellow belt certified) (Pfizer Global Manufacturing / Supply)

-Internship at inpatient pharmacy/ E.R- (Dr. Ziauddin Hospital- Pakistan) (9 months)

KEY RESPONSIBILITIES HANDLED:

-Area/ Documents inspections

-Performing in process quality assurance checks.

-Issuing of line clearance at every step of batch manufacturing

-Annual product review.

-Documentation/ documents review

-Maintaining and updating the Batch Manufacturing Records

-Documentation of log books, calibration records, temperature and humidity records etc.

-Internal audit, internal audit documentation.

PERSONAL QUALITIES:

-Quick Learner.

-Positive Attitude.

-Working in a fast paced environment

-Good Interpersonal and Team skills.

-Excellent presentation / communication skills.

PROFESSIONAL SKILLS:

SOP trainings, QA documentation, Inspection, Handling of Quality control laboratory instruments related to qualitative/ quantitative analysis

COMPUTER SKILL:

-Operating System: Windows 2000, XP. Win 7

-Applications: MSOffice, Adobe Photoshop, PDF

-Internet

PERSONAL SKILLS:

Ability to safely and successfully perform the essential job functions.

Ability to maintain regular, punctual attendance as per company’s policy.

Able to talk, listen and speak clearly.

Able to train the junior staff.

ACADEMIC QUALIFICATION:

-DOCTOR OF PHARMACY– pharm-D (2005-2010)

-HIGHER SCHOOL CERTIFICATE- (HSC) (2002 – 2004)

PERSONAL DETAILS:

-Ethnicity- Asian

-Language Known: English –Excellent

Urdu - Excellent

Arabic – beginner

REFERENCES:

Will be furnished upon request

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