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Quality Manager manager microbiology

Location:
Karachi, Sindh, Pakistan
Salary:
RS 150000 TO 200000
Posted:
February 01, 2020

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Resume:

RESUME

Name/Designation: RAJA ABDUL RAZZAK

Experience: 35 years

HEAD PRINCIPAL SCIENTIST MICROBIOLOGIST/

Principal Biotechnologist

HEAD CLINICAL DIAGNOSTIC LABS / LAB MANAGER

CANCER MEDICAL HOSPITAL KARACHI PAKISTAN

M.SC. MICROBIOLOGY (1983)

Subsidiary Subjects BIOCHEMISTRY BOTANY

DEPTT OF MICROBIOLOGY

UNIVERSITY OF KARACHI PAKISTAN

adbjct@r.postjobfree.com .

adbjct@r.postjobfree.com

adbjct@r.postjobfree.com

Mobile +92-335******* +923*********

Date of Birth: 10th May 1960

No of Publications (i) International / National: 42

PROFESSIONAL EXPERIENCE 35 YEARS

MICROBIOLOGIST IN QUALITY ASSURANCE DEPTT

PRODUCT MANAGEMENT IN MARKETING DEPTT

KARACHI PAKISTAN

SCIENTIFIC OFFICER (MICROBIOLOGY) 22-1-1987 to 1-12-1992

SENIOR SCIENTIST MICROBIOLOGY 1-12-1992 to 1-12-2001

PRINCIPAL SCIENTIST MICROBIOLOGY 1-12-2001 till date

PRINCIPAL SCIENTIST BIOTECHNOLOGY / MICROBIOLOGY

PRINCIPAL SCIENTIST

HEAD CLINICAL DIAGNOSTIC LABS CANCER / MEDICAL HOSPITAL KARACHI PAKISTAN

Quality Objectives and my responsibilities as Head Clinical Laboratories are as follows:

Provision of accurate and timely quality results using RIA/IRMA and Pathological Techniques of Clinical Laboratories and skilled expertise for complete satisfaction of patients and their referring physicians.

To supervise deliver reports to the patient/attendants

Radioimmunoassay is highly sensitive and specific technique for estimation of minute quantities of hormones, drugs and many other substances in serum.

Estimation of FT3, FT4 and TSH method involves antigen-antibody reaction, which is like a lock and key system which is highly specific as there is negligible cross reactivity during the reactions.

Being HEAD of the Clinical Laboratory I am involved in the following tasks:

To check/verify the quality of kits, reagents and other items purchased for Radioimmunoassay section.

Checking the quality control of Radioimmunoassay Lab. equipment

Checking quality controls of RIA kits and tests performed on Immulite system.

Checking the patients reports of Radioimmunoassay section and pathological section.

To Ensure the delivery of reports to the patients in time.

Upgrading existing facilities of RIA section and pathological section with Humastar 600 automatic analyser & ELIZA and estimation of fertility hormones

Checking the quality management system requirements and their implementation.

To design and prepare the technical documents of diagnostic labs. and implement the QMS and keep record as per requirement of ISO 9001-2008.

A procedure for control of documents and records is developed to carry out activities or processes in a planned and systematic manner as per requirements of a comprehensive quality management system (QMS)

Perform and supervise laboratory testing to support release of product and materials (for example: sterility, endotoxin, bioburden, particulate profiling, microbial identifications, growth promotion, and/or biological indicators).

• Perform data entry. Ensure that others carry out laboratory duties in a manner consistent with cGMP.

• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.

• Ensure proper documentation practices during job activities.

• Guide others on SOPs (Standard Operating Procedures), control documents, and/or work instructions

and complete required training.

• Train others on systems, software, equipment, machines, procedures, and/or processes.

• Answer compliance and process questions from others.

• Communicate policies and procedures to other employees.

• Collect, record, and report metrics. Assist in visual tracking to enhance trend analysis.

• Gather, organize, and communicate operational information to others.

• Involvement in investigations and studies with supervision. Conduct troubleshooting activities and investigate possible root cause(s).

• Involvement in improvement activities and teams to meet strategic goals.

• Communicate activities and progress to team on a continuing basis.

• Ensure that you have the tools needed to perform the job.

• Analyse trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.

• Assist in the development of lean processes and procedures.

• Identify temporary and permanent fixes to address issues.

• Involvement in gathering key performance indicators to meet strategic goals.

• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.

• Review and approve documentation needed for qualification of equipment and processes.

• Review completed documentation (eg. logbook reviews) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance.

• Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.

• Author and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.

• Coordinate with representatives from other departments.

• Alert manager when problems occur outside of SOPs (Standard Operating Procedures).

• Attend team meetings to discuss progress, initiatives, and/or other matters.

• Monitor equipment and/or systems for performance and problem indicators.

• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).

• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.

• Assess and implement improvements in productivity, reduced waste generation, quality, and cost.

• Conduct presentations for diverse audiences both inside and outside of the department



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